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2. Rationale and design of CONTINUITY: a Phase 4 randomized controlled trial of continued post-discharge sodium zirconium cyclosilicate treatment versus standard of care for hyperkalemia in chronic kidney disease

Author

Burton, James O, Allum, Alaster M, Amin, Alpesh, Linde, Cecilia, Lesén, Eva, Mellström, Carl, Eudicone, James M, and Sood, Manish M

Subjects
Prevention, Kidney Disease, Patient Safety, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Renal and urogenital, chronic kidney disease, chronic renal insufficiency, clinical trial, heart failure, hyperkalemia
Abstract

BackgroundIndividuals with chronic kidney disease (CKD) hospitalized with hyperkalemia are at risk of hyperkalemia recurrence and re-hospitalization. We present the rationale and design of CONTINUITY, a study to examine the efficacy of continuing sodium zirconium cyclosilicate (SZC)-an oral, highly selective potassium (K+) binder-compared with standard of care (SoC) on maintaining normokalemia and reducing re-hospitalization and resource utilization among participants with CKD hospitalized with hyperkalemia.MethodsThis Phase 4, randomized, open-label, multicenter study will enroll adults with Stage 3b-5 CKD and/or estimated glomerular filtration rate 5.0-≤6.5 mmol/L, without ongoing K+ binder treatment. The study will include an in-hospital phase, where participants receive SZC for 2-21 days, and an outpatient (post-discharge) phase. At discharge, participants with sK+ 3.5-5.0 mmol/L will be randomized (1:1) to SZC or SoC and monitored for 180 days. The primary endpoint is the occurrence of normokalemia at 180 days. Secondary outcomes include incidence and number of hospital admissions or emergency department visits both with hyperkalemia as a contributing factor, and renin-angiotensin-aldosterone system inhibitor down-titration. The safety and tolerability of SZC will be evaluated.Ethics approval has been received from all relevant ethics committees. Enrollment started March 2022 and the estimated study end date is December 2023.ConclusionsThis study will assess the potential of SZC versus SoC in managing people with CKD and hyperkalemia post-discharge.Trial registrationClinicalTrials.gov identifier: NCT05347693; EudraCT: 2021-003527-14, registered on 19 October 2021.

Published
2023

4. Apixaban vs Aspirin According to CHA2DS2-VASc Score in Subclinical Atrial Fibrillation: Insights From ARTESiA

Author

Lopes, Renato D., Granger, Christopher B., Wojdyla, Daniel M., McIntyre, William F., Alings, Marco, Mani, Thenmozhi, Ramasundarahettige, Chinthanie, Rivard, Lena, Atar, Dan, Birnie, David H., Boriani, Giuseppe, Amit, Guy, Leong-Sit, Peter, Rinne, Claus, Duray, Gabor Z., Gold, Michael R., Hohnloser, Stefan H., Kutyifa, Valentina, Benezet-Mazuecos, Juan, Cosedis Nielsen, Jens, Sticherling, Christian, Benz, Alexander P., Linde, Cecilia, Kautzner, Joseph, Mabo, Philippe, Mairesse, Georges H., Connolly, Stuart J., and Healey, Jeff S.

Published
2024
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11. Iron deficiency in new onset heart failure: association with clinical factors and quality of life

Author

Cabrera, Carin Corovic, primary, Ekström, Mattias, additional, Tornvall, Per, additional, Löfström, Ulrika, additional, Frisk, Christoffer, additional, Linde, Cecilia, additional, Hage, Camilla, additional, Persson, Hans, additional, Eriksson, Maria J., additional, Wallén, Håkan, additional, Persson, Bengt, additional, and Lyngå, Patrik, additional

Published
2024
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12. Identifying risk of adverse outcomes in COVID-19 patients via artificial intelligence–powered analysis of 12-lead intake electrocardiogram

Author

Sridhar, Arun R., Chen (Amber), Zih-Hua, Mayfield, Jacob J., Fohner, Alison E., Arvanitis, Panagiotis, Atkinson, Sarah, Braunschweig, Frieder, Chatterjee, Neal A., Zamponi, Alessio Falasca, Johnson, Gregory, Joshi, Sanika A., Lassen, Mats C.H., Poole, Jeanne E., Rumer, Christopher, Skaarup, Kristoffer G., Biering-Sørensen, Tor, Blomstrom-Lundqvist, Carina, Linde, Cecilia M., Maleckar, Mary M., and Boyle, Patrick M.

Published
2022
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18. Integration of implantable device therapy in patients with heart failure. A clinical consensus statement from the Heart Failure Association (HFA) and European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC)

Author

Mullens, Wilfried, Dauw, Jeroen, Gustafsson, Finn, Mebazaa, Alexandre, Steffel, Jan, Witte, Klaus K., Delgado, Victoria, Linde, Cecilia, Vernooy, Kevin, Anker, Stefan D., Chioncel, Ovidiu, Milicic, Davor, Hasenfuss, Gerd, Ponikowski, Piotr, Stephan von Bardeleben, Ralph, Koehler, Friedrich, Ruschitzka, Frank, Damman, Kevin, Schwammenthal, Ehud, Testani, Jeffrey M., Zannad, Faiez, Boehm, Michael, Cowie, Martin R., Dickstein, Kenneth, Jaarsma, Tiny, Filippatos, Gerasimos, Volterrani, Maurizio, Thum, Thomas, Adamopoulos, Stamatis, Cohen-Solal, Alain, Moura, Brenda, Rakisheva, Amina, Ristic, Arsen, Bayes-Genis, Antoni, Van Linthout, Sophie, Tocchetti, Carlo Gabriele, Savarese, Gianluigi, Skouri, Hadi, Adamo, Marianna, Amir, Offer, Yilmaz, Mehmet Birhan, Simpson, Maggie, Tokmakova, Mariya, Gonzalez, Arantxa, Piepoli, Massimo, Seferovic, Petar, Metra, Marco, Coats, Andrew J. S., Rosano, Giuseppe M. C., Mullens, Wilfried, Dauw, Jeroen, Gustafsson, Finn, Mebazaa, Alexandre, Steffel, Jan, Witte, Klaus K., Delgado, Victoria, Linde, Cecilia, Vernooy, Kevin, Anker, Stefan D., Chioncel, Ovidiu, Milicic, Davor, Hasenfuss, Gerd, Ponikowski, Piotr, Stephan von Bardeleben, Ralph, Koehler, Friedrich, Ruschitzka, Frank, Damman, Kevin, Schwammenthal, Ehud, Testani, Jeffrey M., Zannad, Faiez, Boehm, Michael, Cowie, Martin R., Dickstein, Kenneth, Jaarsma, Tiny, Filippatos, Gerasimos, Volterrani, Maurizio, Thum, Thomas, Adamopoulos, Stamatis, Cohen-Solal, Alain, Moura, Brenda, Rakisheva, Amina, Ristic, Arsen, Bayes-Genis, Antoni, Van Linthout, Sophie, Tocchetti, Carlo Gabriele, Savarese, Gianluigi, Skouri, Hadi, Adamo, Marianna, Amir, Offer, Yilmaz, Mehmet Birhan, Simpson, Maggie, Tokmakova, Mariya, Gonzalez, Arantxa, Piepoli, Massimo, Seferovic, Petar, Metra, Marco, Coats, Andrew J. S., and Rosano, Giuseppe M. C.

Abstract

Implantable devices form an integral part of the management of patients with heart failure (HF) and provide adjunctive therapies in addition to cornerstone drug treatment. Although the number of these devices is growing, only few are supported by robust evidence. Current devices aim to improve haemodynamics, improve reverse remodelling, or provide electrical therapy. A number of these devices have guideline recommendations and some have been shown to improve outcomes such as cardiac resynchronization therapy, implantable cardioverter-defibrillators and long-term mechanical support. For others, more evidence is still needed before large-scale implementation can be strongly advised. Of note, devices and drugs can work synergistically in HF as improved disease control with devices can allow for further optimization of drug therapy. Therefore, some devices might already be considered early in the disease trajectory of HF patients, while others might only be reserved for advanced HF. As such, device therapy should be integrated into HF care programmes. Unfortunately, implementation of devices, including those with the greatest evidence, in clinical care pathways is still suboptimal. This clinical consensus document of the Heart Failure Association (HFA) and European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC) describes the physiological rationale behind device-provided therapy and also device-guided management, offers an overview of current implantable device options recommended by the guidelines and proposes a new integrated model of device therapy as a part of HF care.

Published
2024
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19. Metabolomic Profile in HFpEF vs HFrEF Patients

Author

Hage, Camilla, Löfgren, Lars, Michopoulos, Filippos, nilsson, Ralph, Davidsson, Pia, Kumar, Chanchal, Ekström, Mattias, Eriksson, Maria J., Lyngå, Patrik, Persson, Bengt, Wallén, Hakan, Gan, Li Ming, Persson, Hans, and Linde, Cecilia

Published
2020
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21. Cardiac Magnetic Resonance Identifies Responders to Cardiac Resynchronization Therapy with an Assessment of Septal Scar and Left Ventricular Dyssynchrony

Author

Larsen, Camilla Kjellstad, primary, Smiseth, Otto A., additional, Duchenne, Jürgen, additional, Galli, Elena, additional, Aalen, John Moene, additional, Lederlin, Mathieu, additional, Bogaert, Jan, additional, Kongsgaard, Erik, additional, Linde, Cecilia, additional, Penicka, Martin, additional, Donal, Erwan, additional, Voigt, Jens-Uwe, additional, and Hopp, Einar, additional

Published
2023
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22. Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation

Author

Healey, Jeff S., primary, Lopes, Renato D., additional, Granger, Christopher B., additional, Alings, Marco, additional, Rivard, Lena, additional, McIntyre, William F., additional, Atar, Dan, additional, Birnie, David H., additional, Boriani, Giuseppe, additional, Camm, A. John, additional, Conen, David, additional, Erath, Julia W., additional, Gold, Michael R., additional, Hohnloser, Stefan H., additional, Ip, John, additional, Kautzner, Josef, additional, Kutyifa, Valentina, additional, Linde, Cecilia, additional, Mabo, Philippe, additional, Mairesse, Georges, additional, Benezet Mazuecos, Juan, additional, Cosedis Nielsen, Jens, additional, Philippon, Francois, additional, Proietti, Marco, additional, Sticherling, Christian, additional, Wong, Jorge A., additional, Wright, David J., additional, Zarraga, Ignatius G., additional, Coutts, Shelagh B., additional, Kaplan, Andrew, additional, Pombo, Marta, additional, Ayala-Paredes, Felix, additional, Xu, Lizhen, additional, Simek, Kim, additional, Nevills, Sandra, additional, Mian, Rajibul, additional, and Connolly, Stuart J., additional

Published
2023
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24. The European Society of Cardiology Cardiac Resynchronization Therapy Survey II: A comparison of cardiac resynchronization therapy implantation practice in Europe and France

Author

Galand, Vincent, Linde, Cecilia, Lellouche, Nicolas, Mansourati, Jacques, Deharo, Jean-Claude, Sagnol, Pascal, Da Costa, Antoine, Horvilleur, Jerome, Defaye, Pascal, Boveda, Serge, Steinbach, Mathieu, Bru, Paul, Rumeau, Philippe, Beard, Thierry, Younsi, Salem, Dickstein, Kenneth, Normand, Camilla, and Leclercq, Christophe

Published
2019
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29. Comorbidities and clinical response to cardiac resynchronization therapy: Patient‐level meta‐analysis from eight clinical trials.

Author

Fudim, Marat, Dalgaard, Frederik, Friedman, Daniel J., Abraham, William T., Cleland, John G.F., Curtis, Anne B., Gold, Michael R., Kutyifa, Valentina, Linde, Cecilia, Ali‐Ahmed, Fatima, Tang, Anthony, Olivas‐Martinez, Antonio, Inoue, Lurdes Y.T., Al‐Khatib, Sana M., and Sanders, Gillian D.

Subjects
CARDIAC pacing, HEART failure, CLINICAL trials, CORONARY artery disease, ATRIAL fibrillation, MORTALITY
Abstract

Aims: Patients with heart failure usually have several other medical conditions that might alter the effects of interventions. We investigated whether the burden of comorbidity modified the clinical response to cardiac resynchronization therapy (CRT). Methods and results: Original patient‐level data from eight randomized trials exploring the effects of CRT versus no CRT were pooled (BLOCK‐HF, MIRACLE, MIRACLE‐ICD, MIRACLE‐ICD II, RAFT, COMPANION, MADIT‐CRT and REVERSE). A prior history of the following comorbidities was considered: episodic or persistent atrial fibrillation (n = 920), coronary artery disease (n = 3732), diabetes (n = 2171), and hypertension (n = 3353). Patients were classified into three groups based on the number of comorbidities: 0, 1–2, or ≥3. The outcomes of interest were time to all‐cause mortality and time to the composite outcome of heart failure hospitalization (HFH) or all‐cause mortality. Outcomes were evaluated within each comorbidity group using a Bayesian hierarchical Weibull survival regression model. Of 6324 patients, 970 (15%) had no comorbidities, 4052 (64%) had 1–2 and 1302 (21%) had ≥3 comorbidities. The adjusted hazard ratio (aHR) for CRT versus no CRT for all‐cause mortality in the overall cohort was 0.79 (95% credible interval [CI] 0.68–0.93) (p = 0.010); for no comorbidities the aHR was 0.54 (95% CI 0.34–0.86), for 1–2 comorbidities was 0.81 (95% CI 0.67–0.97) and for ≥3 comorbidities was 0.83 (95% CI 0.64–1.07) (no significant interaction between CRT and comorbidity burden: p = 0.13). For the endpoint of HFH or all‐cause mortality, the aHR for the overall cohort was 0.74 (95% CI 0.65–0.84) (p = 0.001), for no comorbidities was 0.69 (95% CI 0.50–0.94), for 1–2 comorbidities was 0.77 (95% CI 0.66–0.90) and for ≥3 comorbidities was 0.68 (95% CI 0.55–0.82) (no significant interaction between CRT and comorbidity burden: p = 0.081). Conclusion: In a meta‐analysis of patient‐level data from eight major trials, the totality of evidence suggests that CRT reduces HFH and/or all‐cause mortality even when several comorbid diseases are present. Clinical Trial Registration: NCT00271154, NCT00251251, NCT00267098, NCT00180271. [ABSTRACT FROM AUTHOR]

Published
2024
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30. Comorbidities and clinical response to cardiac resynchronization therapy: patient‐level meta‐analysis from eight clinical trials

Author

Fudim, Marat, primary, Dalgaard, Frederik, additional, Friedman, Daniel J., additional, Abraham, William T., additional, Cleland, John G.F., additional, Curtis, Anne B., additional, Gold, Michael R., additional, Kutyifa, Valentina, additional, Linde, Cecilia, additional, Ali‐Ahmed, Fatima, additional, Tang, Anthony, additional, Olivas‐Martinez, Antonio, additional, Inoue, Lurdes Y.T., additional, Al‐Khatib, Sana M., additional, and Sanders, Gillian D., additional

Published
2023
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34. Contributors

Author

Albakri, Aref, primary, AlMahameed, Soufian T., additional, Andršová, Irena, additional, Asirvatham, Samuel J., additional, Avari Silva, Jennifer N., additional, Bacharova, Ljuba, additional, Bagliani, Giuseppe, additional, Barakat, Rody, additional, Barakat, Michel M., additional, Barletta, Valentina, additional, Barthel, Petra, additional, Bébarová, Markéta, additional, Beck, Hiroko, additional, Belhassen, Bernard, additional, Bende, Girish, additional, Berkefeld, Anna, additional, Birgersdotter-Green, Ulrika, additional, Blinova, Ksenia, additional, Blomström-Lundqvist, Carina, additional, Bongiorni, Maria Grazia, additional, Brand, Thomas, additional, Bugiardini, Raffaele, additional, Bunch, T. Jared, additional, Castiglione, Alessandro, additional, Cenko, Edina, additional, Chatzidou, Sofia, additional, Chee, Jennifer, additional, Chelu, Mihail G., additional, Chen, Shih Ann, additional, Ciconte, Giuseppe, additional, Curtis, Anne B., additional, Curtis, Stephanie, additional, Cygankiewicz, Iwona, additional, Dalal, Aarti S., additional, Day, John D., additional, Della Tommasina, Veronica, additional, Deshmukh, Abhishek J., additional, Dilaveris, Polychronis, additional, Di Summa, Roberto, additional, Dogan, Mehmet, additional, Dong, Jun, additional, du Fay de Lavallaz, Jeanne, additional, Eckhardt, Lee L., additional, Efimova, Elena, additional, Ernst, Sabine, additional, Fawzy, Ameenathul M., additional, Gaita, Fiorenzo, additional, Garber, Libet, additional, Garnett, Christine, additional, Georgiopoulos, Georgios, additional, Gillis, Anne M., additional, Giustetto, Carla, additional, Gonzalez Corcia, M. Cecilia, additional, Haim, Moti, additional, Halliday, Brian P., additional, Hamdan, Mohamed H., additional, Hammersley, Daniel J., additional, Hartikainen, Juha E.K., additional, Haugaa, Kristina H., additional, Haukilahti, M. Anette E., additional, Hautala, Arto J., additional, Helánová, Kateřina, additional, Hnatkova, Katerina, additional, Hu, Yu-Feng, additional, Hu, Xiao, additional, Hurley, David, additional, Iwai, Sei, additional, Jacobs, Victoria, additional, Jacobson, Jason T., additional, James, Cynthia A., additional, Jiang, Hongying, additional, Jones, Camelle, additional, Jones, Richard E., additional, Junttila, M. Juhani, additional, Kadish, Alan H., additional, Karavirta, Laura, additional, Karim, Saima, additional, Karnad, Dilip, additional, Karunatilleke, Anne, additional, Kaufman, Elizabeth S., additional, Kenttä, Tuomas V., additional, Kezerle, Louise, additional, Khalil, Fouad M., additional, Klingenheben, Thomas, additional, Kloosterman, M., additional, Kontogiannis, Christos, additional, Kowlgi, Gurukripa N., additional, Kroman, Anne M., additional, Kutyifa, Valentina, additional, Lampert, Rachel, additional, Laukkanen, Jari, additional, Lee, Hyon Jae, additional, Leinveber, Pavel, additional, Leren, Ida S., additional, Lima, Fabio V., additional, Linde, Cecilia, additional, Locati, Emanuela T., additional, Macfarlane, Peter W., additional, Maclachlan, Hamish, additional, Mäkikallio, Timo H., additional, Malik, Marek, additional, Manfrini, Olivia, additional, Marashly, Qussay, additional, Margioula, Eleni, additional, McCaffrey, James A., additional, Mehra, Nandini S., additional, Milman, Anat, additional, Moharem-Elgamal, Sarah, additional, Mujović, Nebojša, additional, Nagarajan, Darbhamulla V., additional, Nemec, Petr, additional, Novotný, Tomáš, additional, O'Neill, Louisa, additional, Odening, Katja E., additional, Panicker, Gopi Krishna, additional, Pappone, Carlo, additional, Patton, Kristen K., additional, Pelter, Michele M., additional, Peyracchia, Mattia, additional, Potpara, Tratjana, additional, Powell, Benjamin E., additional, Preben, Bjerregaard, additional, Sarkozy, Andrea, additional, Schneider, Birke, additional, Segreti, Luca, additional, Selzman, Kimberly A., additional, Sharma, Sanjay, additional, Šišáková, Martina, additional, Spears, D.A., additional, Spera, Francesco Raffaele, additional, Špinarová, Lenka, additional, Stein, Phyllis K., additional, Stergiopoulos, Kathleen, additional, Sticherling, Christian, additional, Stuart, Graham, additional, Sugrue, Alan M., additional, Svennberg, Emma, additional, Tada, Hiroshi, additional, Tampakis, Konstantinos, additional, Tereshchenko, Larisa G., additional, Terho, Henri, additional, te Riele, Anneline S.J.M., additional, Tikkanen, Jani T., additional, Toman, Ondřej, additional, Toso, Elisabetta, additional, Tracy, Cynthia M., additional, Trifunovic, Danijela, additional, Turner, James M.A., additional, Vaidya, Vaibhav R., additional, Van Gelder, Isabelle C., additional, Vasavan, Tharni, additional, Verrier, Richard L., additional, Veseli, Granit, additional, Vicente, Jose, additional, Williamson, Catherine, additional, Wu, Wendy W., additional, YH. Lip, Gregory, additional, Younis, Arwa, additional, Zabel, Markus, additional, Zathar, Zafraan, additional, Zegre-Hemsey, Jessica K., additional, Zheng, Nan, additional, and Zucchelli, Giulio, additional

Published
2020
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38. Chronic kidney disease and cardiac remodelling in patients with mild heart failure: results from the REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE) study

Author

Mathew, Jehu, Katz, Ronit, Sutton, Martin John, Dixit, Sanjay, Gerstenfeld, Edward P, Ghio, Stefano, Gold, Michael R, Linde, Cecilia, Shlipak, Michael G, and Deo, Rajat

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Sciences, Heart Disease, Clinical Trials and Supportive Activities, Kidney Disease, Clinical Research, Cardiovascular, Aetiology, 2.1 Biological and endogenous factors, Renal and urogenital, Aged, Biomarkers, Cardiac Resynchronization Therapy, Chi-Square Distribution, Double-Blind Method, Echocardiography, Female, Heart Failure, Systolic, Humans, Kidney Failure, Chronic, Kidney Function Tests, Linear Models, Male, Middle Aged, Proportional Hazards Models, Prospective Studies, Risk Factors, Ventricular Dysfunction, Left, Ventricular Remodeling, Chronic kidney disease, Heart failure, Cardiac resynchronization therapy, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

AimsChronic kidney disease (CKD) is a risk factor for left ventricular hypertrophy (LVH) and heart failure. We evaluated the effect of CKD on left ventricular (LV) remodelling among patients with mild heart failure.Methods and resultsREVERSE was a randomized, controlled trial evaluating cardiac resynchronization therapy (CRT) in patients with New York Heart Association (NYHA) class I/II heart failure. CKD was defined as an estimated glomerular filtration rate (eGFR)

Published
2012

39. Cardiac resynchronization therapy in patients with a prior history of atrial fibrillation: Insights from four major clinical trials

Author

Dalgaard, Frederik, primary, Fudim, Marat, additional, Al‐Khatib, Sana M., additional, Friedman, Daniel J., additional, Abraham, William T., additional, Cleland, John G. F., additional, Curtis, Anne B., additional, Gold, Michael R., additional, Kutyifa, Valentina, additional, Linde, Cecilia, additional, Young, James, additional, Ali‐Ahmed, Fatima, additional, Tang, Anthony, additional, Olivas‐Martinez, Antonio, additional, Inoue, Lurdes Y. T., additional, and Sanders, Gillian D., additional

Published
2023
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40. Outcomes of Cardiac Resynchronization Therapy by New York Heart Association Class: A Patient-Level Meta-Analysis

Author

Shivakumar, Nishkala, primary, Friedman, Daniel J., additional, Fudim, Marat, additional, Abraham, William T., additional, Cleland, John G. F., additional, Curtis, Anne B., additional, Gold, Michael R., additional, Kutyifa, Valentina, additional, Linde, Cecilia, additional, Young, James, additional, Tang, Anthony, additional, Olivas-Martinez, Antonio, additional, Inoue, Lurdes Y.T., additional, Sanders, Gillian D., additional, and Al-Khatib, Sana M., additional

Published
2023
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42. PO-02-027 RELATIONSHIP BETWEEN SEX, BODY SIZE, AND CRT BENEFIT: A PATIENT LEVEL META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS

Author

Friedman, Daniel J., primary, Al-Khatib, Sana M., additional, Cleland, John G., additional, Dalgaard, Frederik, additional, Fudim, Marat, additional, Abraham, William T., additional, Curtis, Anne B., additional, Gold, Michael R., additional, Kutyifa, Valentina, additional, Linde, Cecilia M., additional, Tang, Anthony S., additional, Olivas-Martinez, Antonio, additional, Inoue, Lurdes, additional, and Sanders, Gillian, additional

Published
2023
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