20 results on '"Filippatos, Gerasimos"'
Search Results
2. Blinded Withdrawal of Long-Term Randomized Treatment With Empagliflozin or Placebo in Patients With Heart Failure.
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Packer, Milton, Butler, Javed, Zeller, Cordula, Pocock, Stuart J., Brueckmann, Martina, Pedro Ferreira, João, Filippatos, Gerasimos, Usman, Muhammad Shariq, Zannad, Faiez, and Anker, Stefan D.
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- 2023
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3. Presence of Peripheral Artery Disease Is Associated With Increased Risk of Heart Failure Events: Insights From EMPEROR-Pooled.
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Verma, Subodh, Dhingra, Nitish K., Bonaca, Marc P., Butler, Javed, Anker, Stefan D., Ferreira, João Pedro, Filippatos, Gerasimos, Januzzi, James L., Lam, Carolyn S.P., Sattar, Naveed, Iwata, Tomoko, Nordaby, Matias, Brueckmann, Martina, Pocock, Stuart J., and Packer, Milton
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- 2023
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4. Association Between Hemoglobin Levels and Efficacy of Intravenous Ferric Carboxymaltose in Patients With Acute Heart Failure and Iron Deficiency: An AFFIRM-AHF Subgroup Analysis.
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Filippatos, Gerasimos, Ponikowski, Piotr, Farmakis, Dimitrios, Anker, Stefan D., Butler, Javed, Fabien, Vincent, Kirwan, Bridget-Anne, Macdougall, Iain C., Metra, Marco, Rosano, Giuseppe, Ruschitzka, Frank, van der Meer, Peter, Wächter, Sandra, and Jankowska, Ewa A.
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IRON deficiency , *HEART failure patients , *HEMOGLOBINS , *SUBGROUP analysis (Experimental design) ,CARDIOVASCULAR disease related mortality - Abstract
Background: Iron deficiency, with or without anemia, is an adverse prognostic factor in heart failure (HF). In AFFIRM-AHF (a randomized, double-blind placebo-controlled trial comparing the effect of intravenous ferric carboxymaltose on hospitalizations and mortality in iron-deficient subjects admitted for acute heart failure), intravenous ferric carboxymaltose (FCM), although having no significant effect on the primary end point, reduced the risk of HF hospitalization (hHF) and improved quality of life versus placebo in iron-deficient patients stabilized after an acute HF (AHF) episode. These prespecified AFFIRM-AHF subanalyses explored the association between hemoglobin levels and FCM treatment effects. Methods: AFFIRM-AHF was a multicenter, double-blind, randomized, placebo-controlled trial of FCM in hospitalized AHF patients with iron deficiency. Patients were stratified by baseline hemoglobin level (<12 versus ≥12 g/dL). In each subgroup, the primary composite (total hHF and cardiovascular death) and secondary (total hHF; total cardiovascular hospitalizations and cardiovascular death; time to cardiovascular death, and time to first/days lost due to hHF or cardiovascular death) outcomes were assessed with FCM versus placebo at week 52. Sensitivity analyses using the World Health Organization anemia definition (hemoglobin level <12 g/dL [women] or <13 g/dL [men]) were performed, among others. Results: Of 1108 AFFIRM-AHF patients, 1107 were included in these subanalyses: 464 (FCM group, 228; placebo group, 236) had a hemoglobin level <12 g/dL, and 643 (FCM, 329; placebo, 314) had a hemoglobin level ≥12 g/dL. Patients with a hemoglobin level <12 g/dL were older (mean, 73.7 versus 69.1 years), with more frequent previous HF (75.0% versus 68.7%), serum ferritin <100 μg/L (75.4% versus 68.1%), and transferrin saturation <20% (87.9% versus 81.4%). For the primary outcome, annualized event rates per 100 patient-years with FCM versus placebo were 71.1 and 73.6 (rate ratio, 0.97 [95% CI, 0.66–1.41]), respectively, and 48.5 versus 72.9 (RR, 0.67 [95% CI, 0.48–0.93]) in the hemoglobin levels <12 and ≥12 g/dL subgroups, respectively. No significant interactions between hemoglobin subgroup and treatment effect were observed for primary (P interaction=0.15) or secondary outcomes. Changes from baseline in hemoglobin, serum ferritin and transferrin saturation were significantly greater with FCM versus placebo in both subgroups between weeks 6 and 52. Findings were similar using the World Health Organization definition for anemia. Conclusions: The effects of intravenous FCM on outcomes in iron-deficient patients stabilized after an AHF episode, including improvements in iron parameters over time, did not differ between patients with hemoglobin levels <12 and ≥12 g/dL. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02937454. [ABSTRACT FROM AUTHOR]
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- 2023
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5. Effect of finerenone on ambulatory blood pressure in chronic kidney disease in type 2 diabetes.
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Agarwal, Rajiv, Ruilope, Luis M., Ruiz-Hurtado, Gema, Haller, Hermann, Schmieder, Roland E., Anker, Stefan D., Filippatos, Gerasimos, Pitt, Bertram, Rossing, Peter, Lambelet, Marc, Nowack, Christina, Kolkhof, Peter, Joseph, Amer, and Bakris, George L
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- 2023
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6. Decongestion with Acetazolamide in Acute Decompensated Heart Failure across the Spectrum of Left Ventricular Ejection Fraction: a Pre-specified Analysis from the ADVOR trial.
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Martens, Pieter, Dauw, Jeroen, Verbrugge, Frederik H., Nijst, Petra, Meekers, Evelyne, Augusto Jr, Silvio Nunes, Ter Maaten, Jozine M., Damman, Kevin, Mebazaa, Alexandre, Filippatos, Gerasimos, Ruschitzka, Frank, Tang, W.H. Wilson, Dupont, Matthias, Mullens, Wilfried, and Augusto, Silvio Nunes Jr
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- 2023
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7. Empagliflozin in Black Versus White Patients with Heart Failure: Analysis of EMPEROR-Pooled.
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Verma, Subodh, Dhingra, Nitish K., Butler, Javed, Anker, Stefan D., Pedro Ferreira, João, Filippatos, Gerasimos, Januzzi, James L., Lam, Carolyn S.P., Sattar, Naveed, Pfarr, Egon, Nordaby, Matias, Brueckmann, Martina, Pocock, Stuart J., Zannad, Faiez, and Packer, Milton
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- 2023
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8. Blood Pressure and Cardiorenal Outcomes With Finerenone in Chronic Kidney Disease in Type 2 Diabetes.
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Ruilope, Luis M., Agarwal, Rajiv, Anker, Stefan D., Filippatos, Gerasimos, Pitt, Bertram, Rossing, Peter, Sarafidis, Pantelis, Schmieder, Roland E., Joseph, Amer, Rethemeier, Nicole, Nowack, Christina, Bakris, George L., Mentenich, Nicole, and FIDELIO-DKD Investigators
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Background: Chronic kidney disease is frequently associated with hypertension and poorly controlled blood pressure can lead to chronic kidney disease progression. Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, significantly improves cardiorenal outcomes in patients with chronic kidney disease and type 2 diabetes. This analysis explored the relationship between office systolic blood pressure (SBP) and cardiorenal outcomes with finerenone in FIDELIO-DKD trial (Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease).Methods: Patients with type 2 diabetes, urine albumin-to-creatinine ratio 30 to 5000 mg/g, and estimated glomerular filtration rate of 25 to <75 mL/min per 1.73 m2 receiving optimized renin-angiotensin system blockade, were randomized to finerenone or placebo. For this analysis, patients (N=5669) were grouped by baseline office SBP quartiles.Results: Finerenone reduced office SBP across the baseline office SBP quartiles, including patients with baseline office SBP of >148 mm Hg. Overall, patients with lower baseline office SBP quartile and greater declines from baseline in SBP were associated with better cardiorenal outcomes. The risk of primary kidney and key secondary cardiovascular composite outcomes was consistently reduced with finerenone versus placebo irrespective of baseline office SBP quartiles (P for interaction 0.87 and 0.78, respectively). A time-varying analysis revealed that 13.8% and 12.6% of the treatment effect with finerenone was attributed to the change in office SBP for the primary kidney composite outcome and the key secondary cardiovascular outcome, respectively.Conclusions: In FIDELIO-DKD, cardiorenal outcomes improved with finerenone irrespective of baseline office SBP. Reductions in office SBP accounted for a small proportion of the treatment effect on cardiorenal outcomes.Registration: URL: https://www.Clinicaltrials: gov; Unique identifier: NCT02540993. [ABSTRACT FROM AUTHOR]- Published
- 2022
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9. Effects of Empagliflozin in Women and Men With Heart Failure and Preserved Ejection Fraction.
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Butler, Javed, Filippatos, Gerasimos, Siddiqi, Tariq Jamal, Ferreira, João Pedro, Brueckmann, Martina, Bocchi, Edimar, Böhm, Michael, Chopra, Vijay K., Giannetti, Nadia, Iwata, Tomoko, Januzzi, James L., Kaul, Sanjay, Piña, Ileana L., Ponikowski, Piotr, Rauch-Kröhnert, Ursula, Shah, Sanjiv J., Senni, Michele, Sumin, Mikhail, Verma, Subodh, and Zhang, Jian
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LEFT heart ventricle , *EVALUATION research , *CARDIOMYOPATHIES , *QUESTIONNAIRES , *HEART failure , *BENZENE , *HEART physiology , *RANDOMIZED controlled trials , *URIC acid , *GLYCOSIDES , *RESEARCH , *RESEARCH methodology , *STROKE volume (Cardiac output) , *COMPARATIVE studies , *DISEASE complications - Abstract
Background: Women and men with heart failure (HF) and preserved ejection fraction may differ in their clinical characteristics and their response to therapy. The aim of this study was to evaluate the influence of sex on the effects of empagliflozin in patients with HF and preserved ejection fraction enrolled in the EMPEROR-Preserved trial (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction).Methods: The effects of empagliflozin on the primary outcome of cardiovascular death or hospitalization for HF and on secondary outcomes (including total HF hospitalization, cardiovascular and all-cause mortality, and Kansas City Cardiomyopathy Questionnaire scores) were compared in women and men in the overall cohort and in subgroups defined by left ventricular ejection fraction (41%-49%, 50%-59%, and ≥60%). The effects of empagliflozin on physiological measures, including changes in systolic blood pressure, uric acid, hemoglobin, body weight, and natriuretic peptide levels, were also assessed.Results: Of the 5988 patients randomized, 2676 (44.7%) were women. In the placebo arm, women tended to have lower risk for adverse outcomes, including a lower risk of all-cause mortality (hazard ratio, 0.69 [95% CI, 0.56, 0.84]). Compared with placebo, empagliflozin reduced the risk of cardiovascular death or hospitalization for HF to a similar degree in both sexes (hazard ratio, 0.81 [95% CI, 0.69, 0.96] for men; and hazard ratio, 0.75 [95% CI, 0.61, 0.92] for women; Pinteraction=0.54). Sex did not modify the relationship between empagliflozin and outcomes across ejection fraction groups. Similar results were seen for secondary outcomes and physiological measures. Compared with placebo, empagliflozin improved the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score to a similar extent in both sexes (1.38 for men versus 1.63 for women at 52 weeks; Pinteraction=0.77); the results were similar for Kansas City Cardiomyopathy Questionnaire overall summary score and total summary score.Conclusions: Empagliflozin produced similar benefits on outcomes and health status in women and men with HF and preserved ejection fraction.Registration: URL: https://www.Clinicaltrials: gov; Unique identifier: NCT03057951. [ABSTRACT FROM AUTHOR]- Published
- 2022
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10. Empagliflozin for Heart Failure With Preserved Left Ventricular Ejection Fraction With and Without Diabetes.
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Filippatos, Gerasimos, Butler, Javed, Farmakis, Dimitrios, Zannad, Faiez, Ofstad, Anne Pernille, Ferreira, João Pedro, Green, Jennifer B., Rosenstock, Julio, Schnaidt, Sven, Brueckmann, Martina, Pocock, Stuart J., Packer, Milton, Anker, Stefan D., and EMPEROR-Preserved Trial Committees and Investigators
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VENTRICULAR ejection fraction , *HEART failure , *EMPAGLIFLOZIN , *HEART failure patients , *GLOMERULAR filtration rate - Abstract
Background: Empagliflozin improves outcomes in patients with heart failure with a preserved ejection fraction, but whether the effects are consistent in patients with and without diabetes remains to be elucidated.Methods: Patients with class II through IV heart failure and a left ventricular ejection fraction >40% were randomized to receive empagliflozin 10 mg or placebo in addition to usual therapy. We undertook a prespecified analysis comparing the effects of empagliflozin versus placebo in patients with and without diabetes.Results: Of the 5988 patients enrolled, 2938 (49%) had diabetes. The risk of the primary outcome (first hospitalization for heart failure or cardiovascular death), total hospitalizations for heart failure, and estimated glomerular filtration rate decline was higher in patients with diabetes. Empagliflozin reduced the rate of the primary outcome irrespective of diabetes status (hazard ratio, 0.79 [95% CI, 0.67, 0.94] for patients with diabetes versus hazard ratio, 0.78 [95% CI, 0.64, 0.95] in patients without diabetes; Pinteraction=0.92). The effect of empagliflozin to reduce total hospitalizations for heart failure was also consistent in patients with and without diabetes. The effect of empagliflozin to attenuate estimated glomerular filtration rate decline during double-blind treatment was also present in patients with and without diabetes, although more pronounced in patients with diabetes (1.77 in diabetes versus 0.98 mL/min/1.73m2 in patients without diabetes; Pinteraction=0.01). Across these 3 end points, the effect of empagliflozin did not differ in patients with prediabetes or normoglycemia (33% and 18% of the patient population, respectively). When investigated as a continuous variable, baseline hemoglobin A1c did not modify the effects on the primary outcome (Pinteraction=0.26). There was no increased risk of hypoglycemic events in either subgroup as compared with placebo.Conclusions: In patients with heart failure and a preserved ejection fraction enrolled in the EMPEROR-Preserved (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction), empagliflozin significantly reduced the risk of heart failure outcomes irrespective of diabetes status at baseline.Registration: URL: https://www.Clinicaltrials: gov; Unique identifier: NCT03057951. [ABSTRACT FROM AUTHOR]- Published
- 2022
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11. Toward a Universal Definition of Etiologies in Heart Failure: Categorizing Causes and Advancing Registry Science.
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Agarwal, Anubha, Tromp, Jasper, Almahmeed, Wael, Angermann, Christiane, Chandramouli, Chanchal, Hyunjai Cho, Don-Ju Choi, Damasceno, Albertino, Filippatos, Gerasimos, Fonarow, Gregg C., Harikrishnan, Sivadasanpillai, Lund, Lars, Masoudi, Fred, Mensah, George A., Pathan, Asad, Perel, Pablo, Pinto, Fausto, Ribeiro, Antonio Luiz, Rich, Stuart, and Yasuhiko Sakata
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- 2024
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12. Impact of Rapid Up-Titration of Guideline-Directed Medical Therapies on Quality of Life: Insights From the STRONG-HF Trial.
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Čelutkienė, Jelena, Čerlinskaitė-Bajorė, Kamilė, Cotter, Gad, Edwards, Christopher, Adamo, Marianna, Arrigo, Mattia, Barros, Marianela, Biegus, Jan, Chioncel, Ovidiu, Cohen-Solal, Alain, Damasceno, Albertino, Diaz, Rafael, Filippatos, Gerasimos, Gayat, Etienne, Kimmoun, Antoine, Léopold, Valentine, Metra, Marco, Novosadova, Maria, Pagnesi, Matteo, and Pang, Peter S.
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BACKGROUND: This analysis provides details on baseline and changes in quality of life (QoL) and its components as measured by EQ-5D-5L questionnaire, as well as association with objective outcomes, applying high-intensity heart failure (HF) care in patients with acute HF. METHODS: In STRONG-HF trial (Safety, Tolerability, and Efficacy of Rapid Optimization, Helped by NT-proBNP Testing, of Heart Failure Therapies) patients with acute HF were randomized just before discharge to either usual care or a high-intensity care strategy of guideline-directed medical therapy up-titration. Patients ranked their state of health on the EQ-5D visual analog scale score ranging from 0 (the worst imaginable health) to 100 (the best imaginable health) at baseline and at 90 days follow-up. RESULTS: In 1072 patients with acute HF with available assessment of QoL (539/533 patients assigned high-intensity care/usual care) the mean baseline EQ-visual analog scale score was 59.2 (SD, 15.1) with no difference between the treatment groups. Patients with lower baseline EQ-visual analog scale (meaning worse QoL) were more likely to be women, self-reported Black and non-European (P <0.001). The strongest independent predictors of a greater improvement in QoL were younger age (P <0.001), no HF hospitalization in the previous year (P <0.001), lower NYHA class before hospital admission (P <0.001) and high-intensity care treatment (mean difference, 4.2 [95% CI, 2.5–5.8]; P <0.001). No statistically significant heterogeneity in the benefits of high-intensity care was seen across patient subgroups of different ages, with left ventricular ejection fraction above or below 40%, NT-proBNP (N-terminal pro-B-type natriuretic peptide) and systolic blood pressure above or below the median value. The treatment effect on the primary end point did not vary significantly across baseline EQ-visual analog scale (P
interaction =0.87). CONCLUSIONS: Early up-titration of guideline-directed medical therapy significantly improves all dimensions of QoL in patients with HF and improves prognosis regardless of baseline self-assessed health status. The likelihood of achieving optimal doses of HF medications does not depend on baseline QoL. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03412201. [ABSTRACT FROM AUTHOR]- Published
- 2024
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13. Finerenone Reduces Risk of Incident Heart Failure in Patients With Chronic Kidney Disease and Type 2 Diabetes: Analyses From the FIGARO-DKD Trial.
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Filippatos, Gerasimos, Anker, Stefan D., Agarwal, Rajiv MS, Ruilope, Luis M., Rossing, Peter, Bakris, George L., Tasto, Christoph, Joseph, Amer, Kolkhof, Peter, Lage, Andrea, Pitt, Bertram, Agarwal, Rajiv, and FIGARO-DKD Investigators
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TYPE 2 diabetes , *HEART failure patients , *CHRONIC kidney failure , *DIABETIC nephropathies , *VENTRICULAR ejection fraction , *CHRONICALLY ill , *KIDNEY failure , *RESEARCH , *HETEROCYCLIC compounds , *RESEARCH methodology , *DISEASE incidence , *EVALUATION research , *COMPARATIVE studies , *RANDOMIZED controlled trials , *STATISTICAL sampling , *HEART failure , *DISEASE complications ,CHRONIC kidney failure complications - Abstract
Background: Chronic kidney disease and type 2 diabetes are independently associated with heart failure (HF), a leading cause of morbidity and mortality. In the FIDELIO-DKD (Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease) and FIGARO-DKD (Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease) trials, finerenone (a selective, nonsteroidal mineralocorticoid receptor antagonist) improved cardiovascular outcomes in patients with albuminuric chronic kidney disease and type 2 diabetes. These prespecified analyses from FIGARO-DKD assessed the effect of finerenone on clinically important HF outcomes.Methods: Patients with type 2 diabetes and albuminuric chronic kidney disease (urine albumin-to-creatinine ratio ≥30 to <300 mg/g and estimated glomerular filtration rate ≥25 to ≤90 mL per min per 1.73 m2, or urine albumin-to-creatinine ratio ≥300 to ≤5000 mg/g and estimated glomerular filtration rate ≥60 mL per min per 1.73 m2), without symptomatic HF with reduced ejection fraction, were randomized to finerenone or placebo. Time-to-first-event outcomes included new-onset HF (first hospitalization for HF [HHF] in patients without a history of HF at baseline); cardiovascular death or first HHF; HF-related death or first HHF; first HHF; cardiovascular death or total (first or recurrent) HHF; HF-related death or total HHF; and total HHF. Outcomes were evaluated in the overall population and in prespecified subgroups categorized by baseline HF history (as reported by the investigators).Results: Overall, 7352 patients were included in these analyses; 571 (7.8%) had a history of HF at baseline. New-onset HF was significantly reduced with finerenone versus placebo (1.9% versus 2.8%; hazard ratio [HR], 0.68 [95% CI, 0.50-0.93]; P=0.0162). In the overall population, the incidences of all HF outcomes analyzed were significantly lower with finerenone than placebo, including an 18% lower risk of cardiovascular death or first HHF (HR, 0.82 [95% CI, 0.70-0.95]; P=0.011), a 29% lower risk of first HHF (HR, 0.71 [95% CI, 0.56-0.90]; P=0.0043) and a 30% lower rate of total HHF (rate ratio, 0.70 [95% CI, 0.52-0.94]). The effects of finerenone on improving HF outcomes were not modified by a history of HF. The incidence of treatment-emergent adverse events was balanced between treatment groups.Conclusions: The results from these FIGARO-DKD analyses demonstrate that finerenone reduces new-onset HF and improves other HF outcomes in patients with chronic kidney disease and type 2 diabetes, irrespective of a history of HF. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02545049. [ABSTRACT FROM AUTHOR]- Published
- 2022
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14. Empagliflozin, Health Status, and Quality of Life in Patients With Heart Failure and Preserved Ejection Fraction: The EMPEROR-Preserved Trial.
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Butler, Javed, Filippatos, Gerasimos, Jamal Siddiqi, Tariq, Brueckmann, Martina, Bohm, Michael, Chopra, Vijay K., Pedro Ferreira, Joao, Januzzi, James L., Kaul, Sanjay, Pina, Ileana L., Ponikowski, Piotr, Shah, Sanjiv J., Senni, Michele, Vedin, Ola, Verma, Subodh, Peil, Barbara, Pocock, Stuart J., Zannad, Faiez, Packer, Milton, and Anker, Stefan D.
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HEART failure patients , *VENTRICULAR ejection fraction , *EMPAGLIFLOZIN , *QUALITY of life , *BENZENE , *LEFT heart ventricle , *RESEARCH , *RESEARCH methodology , *GLYCOSIDES , *HEALTH status indicators , *EVALUATION research , *COMPARATIVE studies , *QUESTIONNAIRES , *STROKE volume (Cardiac output) , *HEART physiology , *HEART failure ,CARDIOVASCULAR disease related mortality - Abstract
Background: Patients with heart failure with preserved ejection fraction have significant impairment in health-related quality of life. In the EMPEROR-Preserved trial (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction), we evaluated the efficacy of empagliflozin on health-related quality of life in patients with heart failure with preserved ejection fraction and whether the clinical benefit observed with empagliflozin varies according to baseline health status.Methods: Health-related quality of life was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and 12, 32, and 52 weeks. Patients were divided by baseline KCCQ Clinical Summary Score (CSS) tertiles, and the effect of empagliflozin on outcomes was examined. The effect of empagliflozin on KCCQ-CSS, Total Symptom Score, and Overall Summary Score was evaluated. Responder analyses were performed to compare the odds of improvement and deterioration in KCCQ related to treatment with empagliflozin.Results: The effect of empagliflozin on reducing the risk of time to cardiovascular death or heart failure hospitalization was consistent across baseline KCCQ-CSS tertiles (hazard ratio, 0.83 [95% CI, 0.69-1.00], 0.70 [95% CI, 0.55-0.88], and 0.82 [95% CI, 0.62-1.08] for scores <62.5, 62.5-83.3, and ≥83.3, respectively; P trend=0.77). Similar results were seen for total heart failure hospitalizations. Patients treated with empagliflozin had significant improvement in KCCQ-CSS versus placebo (+1.03, +1.24, and +1.50 at 12, 32, and 52 weeks, respectively; P<0.01); similar results were seen for Total Symptom Score and Overall Summary Score. At 12 weeks, patients on empagliflozin had higher odds of improvement ≥5 points (odds ratio, 1.23 [95% CI, 1.10-1.37]), ≥10 points (odds ratio, 1.15 [95% CI, 1.03-1.27]), and ≥15 points (odds ratio, 1.13 [95% CI, 1.02-1.26]) and lower odds of deterioration ≥5 points in KCCQ-CSS (odds ratio, 0.85 [95% CI, 0.75-0.97]). A similar pattern was seen at 32 and 52 weeks, and results were consistent for Total Symptom Score and Overall Summary Score.Conclusions: In patients with heart failure with preserved ejection fraction, empagliflozin reduced the risk for major heart failure outcomes across the range of baseline KCCQ scores. Empagliflozin improved health-related quality of life, an effect that appeared early and was sustained for at least 1 year. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03057951. [ABSTRACT FROM AUTHOR]- Published
- 2022
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15. Effect of Empagliflozin on Worsening Heart Failure Events in Patients With Heart Failure and Preserved Ejection Fraction: EMPEROR-Preserved Trial.
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Packer, Milton, Butler, Javed, Zannad, Faiez, Filippatos, Gerasimos, Pedro Ferreira, Joao, Pocock, Stuart J., Carson, Peter, Anand, Inder, Doehner, Wolfram, Haass, Markus, Komajda, Michel, Miller, Alan, Pehrson, Steen, Teerlink, John R., Schnaidt, Sven, Zeller, Cordula, Schnee, Janet M., Anker, Stefan D., and Ferreira, Joao Pedro
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- 2021
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16. Impact of Sacubitril/Valsartan Versus Ramipril on Total Heart Failure Events in the PARADISE-MI Trial.
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Pfeffer, Marc A., Claggett, Brian, Lewis, Eldrin F., Granger, Christopher B., Kober, Lars, Maggioni, Aldo P., Mann, Douglas L., McMurray, John J.V., Rouleau, Jean-Lucien, Solomon, Scott D., Steg, Philippe Gabriel, Berwanger, Otavio, Cikes, Maja, De Pasquale, Carmine G., Fernandez, Alberto, Filippatos, Gerasimos, Jering, Karola, Landmesser, Ulf, Menon, Venugopal, and Merkely, Bela
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- 2022
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17. Response by Filippatos et al to Letter Regarding Article, "Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes".
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Filippatos, Gerasimos, Agarwal, Rajiv, Bakris, George, Anker, Stefan, and FIDELIO-DKD Committees and Investigators
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TYPE 2 diabetes , *CHRONIC kidney failure , *TREATMENT effectiveness , *CHRONICALLY ill , *HETEROCYCLIC compounds , *DISEASE complications - Published
- 2021
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18. Interatrial Shunt Treatment for Heart Failure: The Randomized RELIEVE-HF Trial.
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Stone GW, Lindenfeld J, Rodés-Cabau J, Anker SD, Zile MR, Kar S, Holcomb R, Pfeiffer MP, Bayes-Genis A, Bax JJ, Bank AJ, Costanzo MR, Verheye S, Roguin A, Filippatos G, Núñez J, Lee EC, Laufer-Perl M, Moravsky G, Litwin SE, Prihadi E, Gada H, Chung ES, Price MJ, Thohan V, Schewel D, Kumar S, Kische S, Shah KS, Donovan DJ, Zhang Y, Eigler NL, and Abraham WT
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Background: An interatrial shunt may provide an autoregulatory mechanism to decrease left atrial pressure and improve heart failure (HF) symptoms and prognosis., Methods: Patients with symptomatic HF with any left ventricular ejection fraction (LVEF) were randomized 1:1 to transcatheter shunt implantation versus a placebo procedure, stratified by reduced (≤40%) versus preserved (>40%) LVEF. The primary safety outcome was a composite of device-related or procedure-related major adverse cardiovascular or neurological events at 30 days compared with a prespecified performance goal of 11%. The primary effectiveness outcome was the hierarchical composite ranking of all-cause death, cardiac transplantation or left ventricular assist device implantation, HF hospitalization, outpatient worsening HF events, and change in quality of life from baseline measured by the Kansas City Cardiomyopathy Questionnaire overall summary score through maximum 2-year follow-up, assessed when the last enrolled patient reached 1-year follow-up, expressed as the win ratio. Prespecified hypothesis-generating analyses were performed on patients with reduced and preserved LVEF., Results: Between October 24, 2018, and October 19, 2022, 508 patients were randomized at 94 sites in 11 countries to interatrial shunt treatment (n=250) or a placebo procedure (n=258). Median (25th and 75th percentiles) age was 73.0 years (66.0, 79.0), and 189 patients (37.2%) were women. Median LVEF was reduced (≤40%) in 206 patients (40.6%) and preserved (>40%) in 302 patients (59.4%). No primary safety events occurred after shunt implantation (upper 97.5% confidence limit, 1.5%; P <0.0001). There was no difference in the 2-year primary effectiveness outcome between the shunt and placebo procedure groups (win ratio, 0.86 [95% CI, 0.61-1.22]; P =0.20). However, patients with reduced LVEF had fewer adverse cardiovascular events with shunt treatment versus placebo (annualized rate 49.0% versus 88.6%; relative risk, 0.55 [95% CI, 0.42-0.73]; P <0.0001), whereas patients with preserved LVEF had more cardiovascular events with shunt treatment (annualized rate 60.2% versus 35.9%; relative risk, 1.68 [95% CI, 1.29-2.19]; P =0.0001; P
interaction <0.0001). There were no between-group differences in change in Kansas City Cardiomyopathy Questionnaire overall summary score during follow-up in all patients or in those with reduced or preserved LVEF., Conclusions: Transcatheter interatrial shunt implantation was safe but did not improve outcomes in patients with HF. However, the results from a prespecified exploratory analysis in stratified randomized groups suggest that shunt implantation is beneficial in patients with reduced LVEF and harmful in patients with preserved LVEF., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03499236.- Published
- 2024
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19. Serum Chloride and the Response to Acetazolamide in Patients With Acute Heart Failure and Volume Overload: A Post Hoc Analysis From the ADVOR Trial.
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Van den Eynde J, Martens P, Dauw J, Nijst P, Meekers E, Ter Maaten JM, Damman K, Filippatos G, Lassus J, Mebazaa A, Ruschitzka F, Dupont M, Mullens W, and Verbrugge FH
- Abstract
Background: Chloride plays a crucial role in renal salt sensing. This study investigates whether serum chloride is associated with clinical outcomes and decongestive response to acetazolamide in patients with acute decompensated heart failure., Methods: This post hoc analysis includes all 519 patients from the ADVOR trial (Acetazolamide in Decompensated Heart Failure With Volume Overload), randomized to intravenous acetazolamide or matching placebo on top of intravenous loop diuretics. The impact of baseline serum chloride on the main trial end points and the treatment effect of acetazolamide was assessed, as was the evolution of serum chloride under decongestive treatment., Results: Hypochloremia (<96 mmol/L) and hyperchloremia (>106 mmol/L) were present in 80 (15%) and 53 (10%), respectively, at baseline. Hypochloremia was associated with significantly slower decongestion, a longer length of hospital stay, and increased risk of all-cause mortality and heart failure readmissions. Acetazolamide increased the odds of successful decongestion and reduced length of stay irrespectively of baseline serum chloride levels. No statistically significant interaction between serum chloride levels and the effect of acetazolamide on death or heart failure readmissions was observed. The placebo group exhibited a progressive decline in serum chloride, which was effectively prevented by acetazolamide ( P <0.001)., Conclusions: Hypochloremia is associated with diuretic resistance and worse clinical outcomes. Add-on acetazolamide therapy improves decongestion across the entire range of serum chloride and prevents the drop in chloride levels caused by loop diuretic monotherapy., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03505788.
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- 2024
- Full Text
- View/download PDF
20. Decongestion With Acetazolamide in Acute Decompensated Heart Failure Across the Spectrum of Left Ventricular Ejection Fraction: A Prespecified Analysis From the ADVOR Trial.
- Author
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Martens P, Dauw J, Verbrugge FH, Nijst P, Meekers E, Augusto SN Jr, Ter Maaten JM, Damman K, Mebazaa A, Filippatos G, Ruschitzka F, Tang WHW, Dupont M, and Mullens W
- Subjects
- Humans, Male, Female, Acetazolamide therapeutic use, Acetazolamide pharmacology, Stroke Volume, Natriuretic Peptide, Brain, Ventricular Function, Left, Sodium Potassium Chloride Symporter Inhibitors, Treatment Outcome, Diuretics therapeutic use, Heart Failure diagnosis, Heart Failure drug therapy, Ventricular Dysfunction, Left drug therapy
- Abstract
Background: Acetazolamide inhibits proximal tubular sodium reabsorption and improved decongestion in the ADVOR (Acetazolamide in Decompensated Heart Failure with Volume Overload) trial. It remains unclear whether the decongestive effects of acetazolamide differ across the spectrum of left ventricular ejection fraction (LVEF)., Methods: This is a prespecified analysis of the randomized, double-blind, placebo-controlled ADVOR trial that enrolled 519 patients with acute heart failure (HF), clinical signs of volume overload (eg, edema, pleural effusion, or ascites), NTproBNP (N-terminal pro-B-type natriuretic peptide) >1000 ng/L, or BNP (B-type natriuretic peptide) >250 ng/mL to receive intravenous acetazolamide (500 mg once daily) or placebo in addition to standardized intravenous loop diuretics (twice that of the oral home maintenance dose). Randomization was stratified according to LVEF (≤40% or >40%). The primary end point was successful decongestion, defined as the absence of signs of volume overload within 3 days from randomization without the need for mandatory escalation of decongestive therapy because of poor urine output., Results: Median LVEF was 45% (25th to 75th percentile; 30% to 55%), and 43% had an LVEF ≤40%. Patients with lower LVEF were younger and more likely to be male with a higher prevalence of ischemic heart disease, higher NTproBNP, less atrial fibrillation, and lower estimated glomerular filtration rate. No interaction on the overall beneficial treatment effect of acetazolamide to the primary end point of successful decongestion (OR, 1.77 [95% CI, 1.18-2.63]; P =0.005; all P values for interaction >0.401) was found when LVEF was assessed per randomization stratum (≤40% or >40%), or as HF with reduced ejection fraction, HF with mildly reduced ejection fraction, and HF with preserved ejection fraction, or on a continuous scale. Acetazolamide resulted in improved diuretic response measured by higher cumulative diuresis and natriuresis and shortened length of stay without treatment effect modification by baseline LVEF (all P values for interaction >0.160)., Conclusions: When added to treatment with loop diuretics in patients with acute decompensated HF, acetazolamide improves the incidence of successful decongestion and diuretic response, and shortens length of stay without treatment effect modification by baseline LVEF., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT03505788.
- Published
- 2023
- Full Text
- View/download PDF
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