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4. Comparing Analytical Methods for Composite End Points in Clinical Trials: Insights from the Vericiguat Global Study in Subjects with Heart Failure With Reduced Ejection Fraction Trial

Author

WESTERHOUT, CYNTHIA M., RATHWELL, SARAH, ANSTROM, KEVIN J., HERNANDEZ, ADRIAN F., PONIKOWSKI, PIOTR, EZEKOWITZ, JUSTIN A., VOORS, ADRIAAN A., FELKER, G. MICHAEL, BAKAL, JEFFREY A., BLAUSTEIN, ROBERT O., NKULIKIYINKA, RICHARD, O'CONNOR, CHRISTOPHER M., and ARMSTRONG, PAUL W.

Published
2024
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9. Assessment of Biomarkers of Myocardial injury, Inflammation, and Renal Function in Heart Failure With Reduced Ejection Fraction: The VICTORIA Biomarker Substudy

Author

DEFILIPPI, CHRISTOPHER R., ALEMAYEHU, WENDIMAGEGN G., VOORS, ADRIAAN A., KAYE, DAVID, BLAUSTEIN, ROBERT O., BUTLER, JAVED, EZEKOWITZ, JUSTIN A., HERNANDEZ, ADRIAN F., LAM, CAROLYN S.P., ROESSIG, LOTHAR, SELIGER, STEPHEN, SHAH, PALAK, WESTERHOUT, CYNTHIA M., ARMSTRONG, PAUL W., and O'CONNOR, CHRISTOPHER M.

Published
2023
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12. Background Medical Therapy and Clinical Outcomes From the VICTORIA Trial

Author

Ezekowitz, Justin A., McMullan, Ciaran J., Westerhout, Cynthia M., Piña, Ileana L., Lopez-Sendon, Jose, Anstrom, Kevin J., Hernandez, Adrian F., Lam, Carolyn S.P., O’Connor, Christopher M., Pieske, Burkert, Ponikowski, Piotr, Roessig, Lothar, Voors, Adriaan A., Koglin, Joerg, Armstrong, Paul W., and Butler, Javed

Published
2023
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13. STREAM-2: Half-Dose Tenecteplase or Primary Percutaneous Coronary Intervention in Older Patients With ST-Segment–Elevation Myocardial Infarction: A Randomized, Open-Label Trial

Author

Van de Werf, Frans, Ristić, Arsen D., Averkov, Oleg V., Arias-Mendoza, Alexandra, Lambert, Yves, Kerr Saraiva, José F., Sepulveda, Pablo, Rosell-Ortiz, Fernando, French, John K., Musić, Ljilja B., Vandenberghe, Katleen, Bogaerts, Kris, Westerhout, Cynthia M., Pagès, Alain, Danays, Thierry, Bainey, Kevin R., Sinnaeve, Peter, Goldstein, Patrick, Welsh, Robert C., and Armstrong, Paul W.

Published
2023
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18. Proteomics Identify Clinical Phenotypes and Predict Functional Outcomes in Heart Failure With Preserved Ejection Fraction: Insights From VITALITY-HFpEF.

Author

deFilippi, Christopher R., Shah, Palak, Shah, Sanjiv J., Alemayehu, Wendimagegn, Lam, Carolyn S. P., Butler, Javed, Roessig, Lothar, O’Connor, Christopher M., Westerhout, Cynthia M., and Armstrong, Paul W.

Abstract

BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) is a heterogeneous syndrome that may emerge from overlapping systemic processes associated with comorbidities. We assessed whether unique clusters of circulating proteins are associated with specific clinical characteristics and functional status at baseline and follow-up in a well-phenotyped cohort of patients with HFpEF. METHODS: We evaluated 368 proteins associated with cardiovascular disease and inflammation in prerandomization blood samples from 763 VITALITY-HFpEF (Vericiguat to Improve Physical Functioning in Daily Living Activities of Patients With HFpEF) participants who had a left ventricular ejection fraction ≥45% and a heart failure decompensation event within 6 months. Proteins were clustered, and their associations with clinical characteristics, baseline, and 24-week functional outcomes (Kansas City Cardiomyopathy Questionnaire Physical Limitation Score, 6-minute walk distance [6MWD], and Fried frailty phenotype) were estimated with linear regression. Elastic net regression was used to derive a proteomic summary composite to predict changes in 24-week functional outcomes. RESULTS: Four unique protein clusters were identified, containing 24, 66, 197, and 81 proteins. At baseline, 2 protein clusters with the hub proteins caspase-3 and Dickkopf-related protein 1 were associated with increased frailty, whereas the cluster with tumor necrosis factor receptor 1 as a hub protein was associated with lower Kansas City Cardiomyopathy Questionnaire Physical Limitation Score and shorter 6MWD. By contrast, the cluster with protein C as a hub protein was associated with less frailty and longer a 6MWD. The 24-week increase in 6MWD was negatively correlated with the protein cluster with caspase-3; the protein C cluster was correlated with less frailty at 24 weeks. The baseline proteomic summary composite predicted observed changes in Kansas City Cardiomyopathy Questionnaire Physical Limitation Score and 6MWD at 24 weeks (r=0.42 and 0.30; P<0.001 for both). CONCLUSIONS: Proteomics differentiate specific baseline functional traits associated with HFpEF and may facilitate phenotyping in a heterogeneous disease. These proteins also provide insights into the diverse pathophysiology of HFpEF and which patients may improve functional status during follow-up. [ABSTRACT FROM AUTHOR]

Published
2024
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20. Is Time of the Essence? The Impact of Time of Hospital Presentation in Acute Heart Failure Insights From ASCEND-HF Trial

Author

Cerbin, Lukasz P, Ambrosy, Andrew P, Greene, Stephen J, Armstrong, Paul W, Butler, Javed, Coles, Adrian, DeVore, Adam D, Ezekowitz, Justin A, Hernandez, Adrian F, Metra, Marco, Starling, Randall C, Tang, Wilson, Teerlink, John R, Voors, Adriaan A, Wu, Angie, O’Connor, Christopher M, and Mentz, Robert J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Clinical Research, Cardiovascular, Good Health and Well Being, Acute Disease, After-Hours Care, Aged, Dyspnea, Emergency Service, Hospital, Female, Heart Failure, Humans, Male, Middle Aged, Mortality, Nitroglycerin, Patient Readmission, Posture, Prognosis, Proportional Hazards Models, Respiratory Sounds, Sodium Potassium Chloride Symporter Inhibitors, Time Factors, Vasodilator Agents, heart failure, presentation, ASCEND-HF, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

OBJECTIVES:As the largest acute heart failure (AHF) trial conducted to date, the global ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial database presented an opportunity to systematically describe the relationship among time of hospital presentation, clinical profile, inpatient management, and outcomes among patients admitted with AHF. BACKGROUND:Time of hospital presentation has been shown to impact outcomes among patients hospitalized with many conditions. However, the association among time of presentation and patient characteristics, management, and clinical outcomes among patients hospitalized with AHF has not been well characterized. METHODS:A post hoc analysis of the ASCEND-HF trial was performed, which enrolled 7,141 patients hospitalized for AHF. Patients were divided based on when they presented to the hospital; regular hours were defined as 9 am to 5 pm, Monday through Friday, and off hours were defined as 5 pm to 9 am, Monday through Friday and weekends. Clinical characteristics and outcomes were compared by time of presentation. RESULTS:Overall, 3,298 patients (46%) presented during off hours. Off-hour patients were more likely to have orthopnea (80% vs. 74%, respectively) and rales (56% vs. 49%, respectively) than regular-hour patients. Off-hour patients were more likely to receive intravenous (IV) nitroglycerin (18% vs. 11%, respectively) and IV loop diuretics (92% vs. 86%, respectively) as initial therapy and reported greater relief from dyspnea at 24 h (odds ratio [OR]: 1.14; 95% confidence interval [CI]: 1.04 to 1.24; p = 0.01) than regular-hour patients. After adjustment, off-hour presentation was associated with significantly lower 30-day mortality (OR: 0.74; 95% CI: 0.57 to 0.96; p = 0.03) and 180-day mortality (hazard ratio [HR]: 0.82; 95% CI: 0.72 to 0.94; p = 0.01) but similar 30-day rehospitalization rates (p = 0.40). CONCLUSIONS:In this AHF trial, patients admitted during off hours exhibited a distinct clinical profile, experienced greater dyspnea relief, and had lower post-discharge mortality than regular-hour patients. These findings have implications for future AHF trials.

Published
2018

23. Abstract 11574: Relationship Between Baseline Electrocardiographic Parameters and Outcomes in Patients With High-Risk Heart Failure With Reduced Ejection Fraction: Insights From the Vericiguat Global Study in Patients With Heart Failure With Reduced Ejection Fraction (VICTORIA) Trial

Author

Yogasundaram, Haran, Zheng, Yinggan, Ly, Eric, Ezekowitz, Justin A, OConnor, Christopher M, Blaustein, Robert O, ROESSIG, Lothar, Temple, Tracy C, Westerhout, Cynthia M, Armstrong, Paul W, and Sandhu, Roopinder

Published
2022
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26. Body Weight Change During and After Hospitalization for Acute Heart Failure: Patient Characteristics, Markers of Congestion, and Outcomes Findings From the ASCEND-HF Trial

Author

Ambrosy, Andrew P, Cerbin, Lukasz P, Armstrong, Paul W, Butler, Javed, Coles, Adrian, DeVore, Adam D, Dunlap, Mark E, Ezekowitz, Justin A, Felker, G Michael, Fudim, Marat, Greene, Stephen J, Hernandez, Adrian F, O'Connor, Christopher M, Schulte, Philip, Starling, Randall C, Teerlink, John R, Voors, Adriaan A, and Mentz, Robert J

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Heart Disease, Clinical Research, Cardiovascular, Clinical Trials and Supportive Activities, Acute Disease, Aged, Dyspnea, Female, Heart Failure, Hospitalization, Humans, Male, Middle Aged, Natriuretic Agents, Natriuretic Peptide, Brain, Treatment Outcome, Urine, Weight Gain, Weight Loss, acute heart failure, body weight, dyspnea, urine output, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

ObjectivesThis study sought to examine the relationships between in-hospital and post-discharge body weight changes and outcomes among patients hospitalized for acute heart failure (AHF).BackgroundBody weight changes during and after hospitalization for AHF and the relationships with outcomes have not been well characterized.MethodsA post hoc analysis was performed of the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide and Decompensated Heart Failure) trial, which enrolled patients admitted for AHF regardless of ejection fraction. In-hospital body weight change was defined as the difference between baseline and discharge/day 10, whereas post-discharge body weight change was defined as the difference between discharge/day 10 and day 30. Spearman rank correlations of weight change, urine output (UOP), and dyspnea relief as assessed by a 7-point Likert scale are described. Logistic and Cox proportional hazards regression was used to evaluate the relationship between weight change and outcomes.ResultsStudy participants with complete body weight data (n = 4,172) had a mean age of 65 ± 14 years, and 66% were male. Ischemic heart disease was reported in 60% of patients and the average ejection fraction was 30 ± 13%. The median change in body weight was -1.0 kg (interquartile range: -2.1 to 0.0 kg) at 24 h and -2.3 kg (interquartile range: -5.0 to -0.7 kg) by discharge/day 10. At hour 24, there was a weak correlation between change in body weight and UOP (r = -0.381), and minimal correlation between body weight change and dyspnea relief (r = -0.096). After risk adjustment, increasing body weight during hospitalization was associated with a 16% increase per kg in the likelihood of 30-day mortality or HF readmission for patients showing weight loss ≤1 kg or weight gain during hospitalization (odds ratio per kg increase 1.16, 95% confidence interval [CI]: 1.09 to 1.27; p < 0.001). Among the subset of patients experiencing >1-kg increase in body weight post-discharge, increasing body weight was associated with higher risk of 180-day mortality (hazard ratio per kg increase 1.16; 95% CI: 1.09 to 1.23; p < 0.001).ConclusionsA substantial number of patients experienced minimal weight loss or frank weight gain in the context of an AHF trial, and increasing body weight in this subset of patients was independently associated with a worse post-discharge prognosis.

Published
2017

32. 2019 Canadian Cardiovascular Society/Canadian Association of Interventional Cardiology Guidelines on the Acute Management of ST-Elevation Myocardial Infarction: Focused Update on Regionalization and Reperfusion

Author

Armstrong, Paul W., Bagai, Akshay, Bainey, Kevin, Cairns, John, Cheskes, Sheldon, Ducas, John, Dzavik, Vlad, Jolly, Sanjit, McVey, Jennifer, Schampaert, Erick, Schnell, Gregory, So, Derek, Wong, Graham C., Welsford, Michelle, Ainsworth, Craig, Abuzeid, Wael, Fordyce, Christopher B., Greene, Jennifer, Huynh, Thao, Lambert, Laurie, Le May, Michel, Lutchmedial, Sohrab, Mehta, Shamir R., Natarajan, Madhu, Norris, Colleen M., Overgaard, Christopher B., Perry Arnesen, Michele, Quraishi, Ata, Tanguay, Jean François, Traboulsi, Mouheiddin, van Diepen, Sean, Welsh, Robert, Wood, David A., and Cantor, Warren J.

Published
2019
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33. Hemoglobin and Clinical Outcomes in the Vericiguat Global Study in Patients With Heart Failure and Reduced Ejection Fraction (VICTORIA)

Author

Ezekowitz, Justin A., Zheng, Yinggan, Cohen-Solal, Alain, Melenovský, Vojtěch, Escobedo, Jorge, Butler, Javed, Hernandez, Adrian F., Lam, Carolyn S.P., O’Connor, Christopher M., Pieske, Burkert, Ponikowski, Piotr, Voors, Adriaan A., deFilippi, Christopher, Westerhout, Cynthia M., McMullan, Ciaran, Roessig, Lothar, and Armstrong, Paul W.

Published
2021
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35. Diuretic use and outcomes in patients with heart failure with reduced ejection fraction: Insights from the VICTORIA trial.

Author

Ezekowitz, Justin, Alemayehu, Wendimagegn, Edelmann, Frank, Ponikowski, Piotr, Lam, Carolyn S.P., O'Connor, Christopher M., Butler, Javed, Corda, Stefano, McMullan, Ciaran J., Westerhout, Cynthia M., Voors, Adriaan A., Mentz, Robert J., and Armstrong, Paul W.

Subjects
HEART failure patients, VENTRICULAR ejection fraction, DIURETICS, TREATMENT effectiveness, HEART failure
Abstract

Aims: In VICTORIA, vericiguat compared with placebo reduced the risk of cardiovascular death (CVD) and heart failure hospitalization (HFH) in patients enrolled after a worsening heart failure (WHF) event. We examined clinical outcomes and efficacy of vericiguat as it relates to background use of loop diuretics in patients with WHF. Methods and results: We calculated the total daily loop diuretic dose equivalent to furosemide dosing at randomization and categorized these as: no loop diuretic, 1–39, 41–80, 40, and >80 mg total daily dose (TDD). The primary composite outcome of CVD/HFH and its components were evaluated based on TDD loop diuretic and expressed as adjusted hazard ratios with 95% confidence intervals. Post‐randomization rates of change in TDD were also examined. Of 4974 patients (98% of the trial) with diuretic dose information available at randomization, 540 (10.8%) were on no loop diuretic, 647 (13.0%) were on 1–39, 1633 (32.8%) were on 40, 1185 (23.8%) were on 41–80, and 969 (19.4%) were on >80 mg TDD. Patients with higher TDD had a higher rate of primary and secondary clinical outcomes. There were no significant interactions with TDD at randomization and efficacy of vericiguat versus placebo for any outcome (all pinteraction > 0.5). Post‐randomization diuretic dose changes for vericiguat and placebo showed similar rates of up‐titration (19.6 and 20.2/100 person‐years), down‐titration (16.8 and 18.1/100 person‐years), and stopping diuretics (22.9 and 24.2/100 person‐years). Conclusions: Loop diuretic TDD at randomization was independently associated with worse outcomes in this high‐risk population. The efficacy of vericiguat was consistent across the range of diuretic doses. [ABSTRACT FROM AUTHOR]

Published
2024
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36. Accelerometer vs. other activity measures in heart failure with preserved ejection fraction: the VITALITY‐HFpEF trial.

Author

Butler, Javed, Khan, Muhammad Shahzeb, Gasior, Tomasz, Erickson, Tyler R., Vlajnic, Vanja, Kramer, Frank, Blaustein, Robert O., Goldsbury, David, Roessig, Lothar, Lam, Carolyn S.P., Anstrom, Kevin J., and Armstrong, Paul W.

Subjects
VENTRICULAR ejection fraction, HEART failure, ACCELEROMETERS, CLINICAL deterioration, LOGISTIC regression analysis
Abstract

Aims: The relationship between accelerometry data and changes in Kansas City Cardiomyopathy Questionnaire‐Physical Limitation Score (KCCQ‐PLS) or 6 min walk test (6MWT) is not well understood. Methods and results: VITALITY‐HFpEF accelerometry substudy (n = 69) data were assessed at baseline and 24 weeks. Ordinal logistic regression models were used to assess the association between accelerometry activity and deterioration, improved, or unchanged KCCQ‐PLS (≥8.33 and ≤ −4.17 points) and 6MWT (≥32 vs. ≤ −32 m). KCCQ‐PLS score deteriorated in 16 patients, improved in 34, and was unchanged in 19. 6MWT deteriorated in 8 patients, improved in 21, and was unchanged in 19. Mean accelerometer wear was 21.4 (±2.1) h/day. Changes in hours active from baseline to 24 weeks were not significantly different among patients who exhibited deterioration, improvement, or no change in KCCQ‐PLS [odds ratio (OR) 0.91, 95% confidence interval (CI) 0.71–1.18; P = 0.48] or 6MWT (OR 1.21, 95% CI 0.91–1.60; P = 0.18). Similar lack of association was observed for other accelerometry metrics and change in KCCQ and 6MWT. These findings were unaffected when KCCQ and 6MWT were examined as continuous variables. Conclusions: Accelerometer‐based activity measures did not correlate with subjective or objective standard measures of health status and functional capacity in heart failure with preserved ejection fraction. Further investigation of their relationships to clinical outcomes is required. [ABSTRACT FROM AUTHOR]

Published
2024
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39. Effects of genetic variation in protease activated receptor 4 after an acute coronary syndrome: Analysis from the TRACER trial

Author

Tricoci, Pierluigi, Neely, Megan, Whitley, Michael J., Edelstein, Leonard C., Simon, Lukas M., Shaw, Chad, Fortina, Paolo, Moliterno, David J., Armstrong, Paul W., Aylward, Philip, White, Harvey, Van de Werf, Frans, Jennings, Lisa K., Wallentin, Lars, Held, Claes, Harrington, Robert A., Mahaffey, Kenneth W., and Bray, Paul F.

Published
2018
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43. Prognostic and Practical Validation of Current Definitions of Myocardial Infarction Associated With Percutaneous Coronary Intervention

Author

Tricoci, Pierluigi, Newby, L. Kristin, Clare, Robert M., Leonardi, Sergio, Gibson, C. Michael, Giugliano, Robert P., Armstrong, Paul W., Van de Werf, Frans, Montalescot, Gilles, Moliterno, David J., Held, Claes, Aylward, Philip E., Wallentin, Lars, Harrington, Robert A., Braunwald, Eugene, Mahaffey, Kenneth W., and White, Harvey D.

Published
2018
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44. 2018 Canadian Cardiovascular Society/Canadian Association of Interventional Cardiology Focused Update of the Guidelines for the Use of Antiplatelet Therapy

Author

Armstrong, Paul W., Bagai, Akshay, Bucci, Claudia, Déry, Jean-Pierre, Diodati, Jean, Dupuis, Jocelyn, Fitchett, David, Love, Michael P., Welsh, Robert, Mehta, Shamir R., Bainey, Kevin R., Cantor, Warren J., Lordkipanidzé, Marie, Marquis-Gravel, Guillaume, Robinson, Simon D., Sibbald, Matthew, So, Derek Y., Wong, Graham C., Abunassar, Joseph G., Ackman, Margaret L., Bell, Alan D., Cartier, Raymond, Douketis, James D., Lawler, Patrick R., McMurtry, Michael S., Udell, Jacob A., van Diepen, Sean, Verma, Subodh, Mancini, G.B. John, Cairns, John A., and Tanguay, Jean-François

Published
2018
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46. Global Collaborative Cardiovascular Research: The Collective Wisdom of Countries.

Author

Armstrong, Paul W.

Subjects
*MYOCARDIAL infarction, *MEDICAL personnel, *MEDICAL quality control, *INFORMATION technology, *ST elevation myocardial infarction, *SOCIAL media
Abstract

The article discusses the unprecedented pace of knowledge transformation in cardiovascular disease research and its impact on health in the past century. It highlights the role of information technology in facilitating research and communication, leading to advancements in data analysis and remote patient monitoring. The article also explores the development of mission-driven academic research organizations (AROs) and their role in conducting large-scale international investigations. It emphasizes the importance of collaboration, standardized protocols, and recognition of individual investigators and clinical sites in promoting a research culture. The article concludes by discussing future avenues for research, including the integration of social sciences and addressing environmental threats to health. [Extracted from the article]

Published
2024
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49. Abstract 14727: Meteorin-like Glial Cell Differentiation Regulator is a Novel Protein Biomarker of Cardiovascular Outcomes in Patients With Diabetes and Vascular Disease: A TECOS Substudy

Author

Truby, Lauren K, Regan, Jessica A, Nguyen, Maggie, Giamberardino, Stephani, Mentz, Robert J, McGarrah, Robert W, Zheng, Yinggan, McGuire, Darren K, Buse, John B, Armstrong, Paul W, Green, Jennifer, standl, eberhard, Peterson, Eric D, Shah, Svati H, and Holman, Rury

Published
2020
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