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1. Global Impact of Optimal Implementation of Guideline-Directed Medical Therapy in Heart Failure

Author

Tang, Amber B, Ziaeian, Boback, Butler, Javed, Yancy, Clyde W, and Fonarow, Gregg C

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Good Health and Well Being, Cardiovascular medicine and haematology
Abstract

ImportanceGuideline-directed medical therapy (GDMT) remains underutilized on a global level, with significant disparities in access to treatment worldwide. The potential global benefits of quadruple therapy on patients with heart failure with reduced ejection fraction (HFrEF) have not yet been estimated.ObjectiveTo assess the projected population-level benefit of optimal GDMT use globally among patients with HFrEF.Design, setting, and participantsEstimates for HFrEF prevalence, contraindications to GDMT, treatment rates, and the number needed to treat for all-cause mortality at 12 months were derived from previously published sources. Potential lives saved from optimal implementation of quadruple therapy among patients with HFrEF was calculated globally and a sensitivity analysis was conducted to account for uncertainty in the existing data.Main outcomes and measuresAll-cause mortality.ResultsOf an estimated 28.89 million people with HFrEF worldwide, there were 8 235 063 (95% CI, 6 296 020-10 762 972) potentially eligible for but not receiving β-blockers, 20 387 000 (95% CI, 15 867 004-26 184 996) eligible for but not receiving angiotensin receptor-neprilysin inhibitors, 12 223 700 (95% CI, 9 376 895-15 924 973) eligible for but not receiving mineralocorticoid receptor antagonists, and 21 229 170 (95% CI, 16 537 400-27 242 688) eligible for but not receiving sodium glucose cotransporter-2 inhibitors. Optimal implementation of quadruple GDMT could potentially prevent 1 188 277 (95% CI, 767 933-1 914 561) deaths over 12 months. A large proportion of deaths averted were projected in Southeast Asia, Eastern Mediterranean and Africa, and the Western Pacific regions.Conclusions and relevanceImprovement in use of GDMT could result in substantial mortality benefits on a global scale. Significant heterogeneity also exists across regions, which warrants additional study with interventions tailored to country-level differences for optimization of GDMT worldwide.

Published
2024

18. Association of an impaired GH-IGF-I axis with cardiac wasting in patients with advanced cancer

Author

Fröhlich, Ann-Kathrin, Porthun, Jan, Talha, Khawaja M., Lena, Alessia, Hadzibegovic, Sara, Wilkenshoff, Ursula, Sonntag, Frederike, Nikolski, Anja, Ramer, Luisa Valentina, Zeller, Tanja, Keller, Ulrich, Bullinger, Lars, Anker, Stefan D., Haverkamp, Wilhelm, von Haehling, Stephan, Doehner, Wolfram, Rauch, Ursula, Skurk, Carsten, Cleland, John G. F., Butler, Javed, Coats, Andrew J. S., Landmesser, Ulf, Karakas, Mahir, and Anker, Markus S.

Published
2024
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20. Kidney function in cachexia and sarcopenia: Facts and numbers.

Author

Okamura, Masatsugu, Konishi, Masaaki, Butler, Javed, von Haehling, Stephan, Anker, Stefan, and Kalantar-Zadeh, Kamyar

Subjects
Cachexia, Chronic kidney disease, Cystatin C, Protein-energy wasting, Sarcopenia, Humans, Cachexia, Cystatin C, Sarcopenia, Creatinine, Renal Insufficiency, Chronic, Kidney
Abstract

Cachexia, in the form of unintentional weight loss >5% in 12 months or less, and secondary sarcopenia in the form of muscle wasting are serious conditions that affect clinical outcomes. A chronic disease state such as chronic kidney disease (CKD) often contributes to these wasting disorders. The purpose of this review is to summarize the prevalence of cachexia and sarcopenia, their relationship with kidney function, and indicators for evaluating kidney function in patients with CKD. It is estimated that approximately half of all persons with CKD will develop cachexia with an estimated annual mortality rate of 20%, but few studies have been conducted on cachexia in CKD. Hence, the true prevalence of cachexia in CKD and its effects on kidney function and patient outcomes remain unclear. Some studies have highlighted the concept of protein-energy wasting (PEW) which usually include sarcopenia and cachexia. Several studies have examined kidney function and CKD progression in patients with sarcopenia. Most studies use serum creatinine levels to estimate kidney function. However, creatinine may be influenced by muscle mass, and creatinine-based glomerular filtration rate may overestimate kidney function in patients with reduced muscle mass or muscle wasting. Cystatin C, which is least affected by muscle mass, has been used in some studies, and creatinine-to-cystatin-C ratio has emerged as an important prognostic marker. A previous study incorporating 428 320 participants reported that participants with CKD and sarcopenia had a 33% higher hazard of mortality compared with those without (7% to 66%, P = 0.011), and that those with sarcopenia were twice as likely to develop end-stage kidney disease (hazard ratio: 1.98; 1.45 to 2.70, P

Published
2023

21. Medication-Attributable Adverse Events in Heart Failure Trials.

Author

Harrington, Josephine, Fonarow, Gregg, Khan, Muhammad, Hernandez, Adrian, Anker, Stefan, Böhm, Michael, Greene, Stephen, Felker, G, Vaduganathan, Muthiah, and Butler, Javed

Subjects
adverse events, guideline-directed medical therapy, heart failure, Humans, Angiotensin Receptor Antagonists, Angiotensin-Converting Enzyme Inhibitors, Heart Failure, Randomized Controlled Trials as Topic, Sodium-Glucose Transporter 2 Inhibitors, Stroke Volume
Abstract

BACKGROUND: Initiation and up-titration of guideline-directed medical therapies (GDMTs) for heart failure with reduced ejection fraction (HFrEF) remains suboptimal, in part because of concerns regarding tolerability and adverse events (AEs). OBJECTIVES: The authors sought to compare rates of AE in patients randomized to GDMT medication vs placebo in a meta-analysis of landmark cardiovascular outcomes trials. METHODS: The authors assessed rates of reported AE in 17 landmark HFrEF clinical trials across each class of GDMT in the placebo and intervention arms. The overall rates of AE for each drug class, the absolute difference in frequency in AEs between the placebo and intervention arms, and the odds of each AE according based on randomization strata were calculated. RESULTS: AE were reported commonly in trials across each class of GDMT, with 75% to 85% of participants reporting at least 1 AE. There was no significant difference in the frequency of AE between the intervention and placebo arms, except for angiotensin-converting enzyme inhibitors (87.0% [95% CI: 85.0%-88.8%] vs 82.0% [95% CI: 79.8%-84.0%], absolute difference: +5% with intervention; P < 0.001). There was no significant difference in drug discontinuation because of AE between placebo and intervention arms in angiotensin-converting enzyme inhibitors, mineralocorticoid receptor antagonists, sodium glucose cotransporter 2 inhibitors, or angiotensin receptor neprilysin inhibitor/angiotensin II receptor blocker trials. Patients randomized to beta-blocker were significantly less likely to stop study drug because of AE than placebo (11.3% [95% CI: 10.3%-12.3%] vs 13.7% [95% CI: 12.5%-14.9%], absolute difference: -1.1%; P = 0.015). When individual types of AE were assessed, the initiation of an intervention vs placebo resulted in small differences in absolute frequency of AE that were largely not statistically significant. CONCLUSIONS: In clinical trials of GDMT for HFrEF, AEs are observed frequently. However, rates of AE are similar between active medication and control, suggesting these may reflect the high risk nature of the heart failure disease state rather than be attributive to a specific therapy.

Published
2023

22. Causal Analysis of the TOPCAT Trial: Spironolactone for Preserved Cardiac Function Heart Failure

Author

Raimondi, Francesca E. D., O'Keeffe, Tadhg, Chockler, Hana, Lawrence, Andrew R., Stemberga, Tamara, Franca, Andre, Sipos, Maksim, Butler, Javed, and Ben-Haim, Shlomo

Subjects
Statistics - Machine Learning, Computer Science - Machine Learning, Statistics - Applications
Abstract

We describe the results of applying causal discovery methods on the data from a multi-site clinical trial, on the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT). The trial was inconclusive, with no clear benefits consistently shown for the whole cohort. However, there were questions regarding the reliability of the diagnosis and treatment protocol for a geographic subgroup of the cohort. With the inclusion of medical context in the form of domain knowledge, causal discovery is used to demonstrate regional discrepancies and to frame the regional transportability of the results. Furthermore, we show that, globally and especially for some subgroups, the treatment has significant causal effects, thus offering a more refined view of the trial results.

Published
2022

25. Home-Time, Mortality, and Readmissions Among Patients Hospitalized With Heart Failure: A Baseline Prior to IMPLEMENT-HF

Author

Tang, Amber B., Solomon, Nicole, Chiswell, Karen, Greene, Stephen J., Yancy, Clyde W., Jessup, Mariell, Kittleson, Michelle, Butler, Javed, Sweitzer, Nancy K., Goldberg, Lee R., Lindenfeld, Jo-Ann, Lewis, Eldrin F., Peterson, Pamela N., Paul, Sara, Serdynski, Lynn Mallas, Rutan, Christine, Congdon, Michelle, Cherkur, Sruthi, and Fonarow, Gregg C.

Published
2024
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26. Applicability of Vericiguat to Patients Hospitalized for Heart Failure in the United States.

Author

Khan, Muhammad, Xu, Haolin, Lautsch, Dominik, Hilkert, Robert, Allen, Larry, DeVore, Adam, Alhanti, Brooke, Yancy, Clyde, Albert, Nancy, Butler, Javed, Greene, Stephen, and Fonarow, Gregg

Subjects
heart failure, hospitalization, trial, vericiguat, Aged, Humans, Female, United States, Heart Failure, Aftercare, Medicare, Patient Discharge, Stroke Volume
Abstract

BACKGROUND: In January 2021, vericiguat, a soluble guanylate cyclase stimulator, was approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of cardiovascular death and heart failure (HF) hospitalization among patients with a recent worsening HF event based on the VICTORIA (VerICiguaT Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial. OBJECTIVES: This study sought to leverage a contemporary U.S. registry of patients hospitalized for heart failure (HF) to characterize patients who may be candidates for vericiguat based on FDA label and the VICTORIA trial eligibility criteria. METHODS: The authors studied patients hospitalized for HF with ejection fraction (EF)

Published
2023

27. Clinical performance and quality measures for heart failure management in China: the China‐Heart Failure registry study

Author

Zhang, Yuhui, Gao, Chuanyu, Greene, Stephen J, Greenberg, Barry H, Butler, Javed, Yu, Jing, Zheng, Zhaofen, Ma, Genshan, Wang, Lian, Yang, Ping, Ji, Xiaoping, Xu, Dingli, Wang, Jiang, Zhang, Yao, Liu, Ying, Zhao, Yan, Qi, Hong, Zhai, Mei, Feng, Jiayu, Huang, Yan, Zhou, Qiong, and Zhang, Jian

Subjects
Cardiovascular, Heart Disease, Clinical Research, Humans, United States, Quality Indicators, Health Care, Hospitalization, Heart Failure, Hospitals, Registries, Heart failure, Medical union, Clinical performance, Quality measures, Quality improvement, Cardiorespiratory Medicine and Haematology
Abstract

AimsHeart failure (HF) remains a major public health problem with increasing prevalence in China. This study evaluated the clinical performance and quality measures for HF management to identify gaps in the standardization of care for patients hospitalized for HF in China.Methods and resultsFollowing the results of China-HF stage I (2012-2015), the second stage of the China-HF was launched in 2017. Among 113 hospitals with ≥100 cases, the China-HF Stage II assessed the quality of care measures for HF and compared results with previous data in China and the US-based Get with The Guidelines-Heart Failure (GWTG-HF) registries. In total, 34 938 patients hospitalized with HF were enrolled from January 2017 to October 2020. Echocardiographic left ventricular function and natriuretic peptide test were performed in 93.7% and 93.0% of the cases, respectively. Adherence to standardized guidelines in China-HF stage II was higher than that in the China-HF stage I, but generally lower than GWTG-HF registry with 78.2% of eligible patients was prescribed oral diuretics, 78.7% renin-angiotensin-system inhibitors, and 82.2% beta-blockers. Implantable cardioverter-defibrillators and cardiac resynchronization devices were implanted in 3.9% and 14.6%, respectively. In contrast, the proportion of eligible patients discharged with spironolactone (87.8%) was higher than GWTG-HF. The median length of hospitalization was 9 (6, 12) days, and 938 (2.8%) patients died or withdrew from treatment during hospitalization.ConclusionsDespite significant improvements in the use of guideline-recommended testing and therapy, there remain major gaps in quality of care for patients hospitalized for HF in China that are generally larger than gaps observed in the United States.

Published
2023

28. The need for increased pragmatism in cardiovascular clinical trials

Author

Usman, Muhammad Shariq, Van Spall, Harriette GC, Greene, Stephen J, Pandey, Ambarish, McGuire, Darren K, Ali, Ziad A, Mentz, Robert J, Fonarow, Gregg C, Spertus, John A, Anker, Stefan D, Butler, Javed, James, Stefan K, and Khan, Muhammad Shahzeb

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Comparative Effectiveness Research, Cardiovascular, Heart Disease, Clinical Trials and Supportive Activities, Prevention, Clinical Research, Good Health and Well Being, Cardiovascular Diseases, Humans, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

The majority of cardiovascular randomized controlled trials (RCTs) test interventions in selected patient populations under explicitly protocol-defined settings. Although these 'explanatory' trial designs optimize conditions to test the efficacy and safety of an intervention, they limit the generalizability of trial findings in broader clinical settings. The concept of 'pragmatism' in RCTs addresses this concern by providing counterbalance to the more idealized situation underpinning explanatory RCTs and optimizing effectiveness over efficacy. The central tenets of pragmatism in RCTs are to test interventions in routine clinical settings, with patients who are representative of broad clinical practice, and to reduce the burden on investigators and participants by minimizing the number of trial visits and the intensity of trial-based testing. Pragmatic evaluation of interventions is particularly important in cardiovascular diseases, where the risk of death among patients has remained fairly stable over the past few decades despite the development of new therapeutic interventions. Pragmatic RCTs can help to reveal the 'real-world' effectiveness of therapeutic interventions and elucidate barriers to their implementation. In this Review, we discuss the attributes of pragmatism in RCT design, conduct and interpretation as well as the general need for increased pragmatism in cardiovascular RCTs. We also summarize current challenges and potential solutions to the implementation of pragmatism in RCTs and highlight selected ongoing and completed cardiovascular RCTs with pragmatic trial designs.

Published
2022

35. Inflammation in Obesity-Related HFpEF: The STEP-HFpEF Program

Author

Verma, Subodh, Petrie, Mark C., Borlaug, Barry A., Butler, Javed, Davies, Melanie J., Kitzman, Dalane W., Shah, Sanjiv J., Rönnbäck, Cecilia, Abildstrøm, Steen Z., Liisberg, Karoline, Wolf, Dennis, von Lewinski, Dirk, Lelonek, Malgorzata, Melenovsky, Vojtech, Senni, Michele, and Kosiborod, Mikhail N.

Published
2024
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37. Effect of Semaglutide on Cardiac Structure and Function in Patients With Obesity-Related Heart Failure

Author

Solomon, Scott D., Ostrominski, John W., Wang, Xiaowen, Shah, Sanjiv J., Borlaug, Barry A., Butler, Javed, Davies, Melanie J., Kitzman, Dalane W., Verma, Subodh, Abildstrøm, Steen Z., Nygaard Einfeldt, Mette, Rasmussen, Søren, Abhayaratna, Walter P., Ahmed, Fozia Z., Ben-Gal, Tuvia, Chopra, Vijay, Ito, Hiroshi, Merkely, Bela, Núñez, Julio, Senni, Michele, van der Meer, Peter, Wolf, Dennis, Petrie, Mark C., and Kosiborod, Mikhail N.

Published
2024
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39. DCRM 2.0: Multispecialty practice recommendations for the management of diabetes, cardiorenal, and metabolic diseases

Author

Handelsman, Yehuda, Anderson, John E., Bakris, George L., Ballantyne, Christie M., Bhatt, Deepak L., Bloomgarden, Zachary T., Bozkurt, Biykem, Budoff, Matthew J., Butler, Javed, Cherney, David Z.I., DeFronzo, Ralph A., Del Prato, Stefano, Eckel, Robert H., Filippatos, Gerasimos, Fonarow, Gregg C., Fonseca, Vivian A., Garvey, W. Timothy, Giorgino, Francesco, Grant, Peter J., Green, Jennifer B., Greene, Stephen J., Groop, Per-Henrik, Grunberger, George, Jastreboff, Ania M., Jellinger, Paul S., Khunti, Kamlesh, Klein, Samuel, Kosiborod, Mikhail N., Kushner, Pamela, Leiter, Lawrence A., Lepor, Norman E., Mantzoros, Christos S., Mathieu, Chantal, Mende, Christian W., Michos, Erin D., Morales, Javier, Plutzky, Jorge, Pratley, Richard E., Ray, Kausik K., Rossing, Peter, Sattar, Naveed, Schwarz, Peter E.H., Standl, Eberhard, Steg, P. Gabriel, Tokgözoğlu, Lale, Tuomilehto, Jaakko, Umpierrez, Guillermo E., Valensi, Paul, Weir, Matthew R., Wilding, John, and Wright, Eugene E., Jr.

Published
2024
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40. 2024 ACC Expert Consensus Decision Pathway on Clinical Assessment, Management, and Trajectory of Patients Hospitalized With Heart Failure Focused Update: A Report of the American College of Cardiology Solution Set Oversight Committee

Author

Hollenberg, Steven M., Stevenson, Lynne Warner, Ahmad, Tariq, Bozkurt, Biykem, Butler, Javed, Davis, Leslie L., Drazner, Mark H., Kirkpatrick, James N., Morris, Alanna A., Page, Robert Lee, II, Siddiqi, Hasan Khalid, Storrow, Alan B., and Teerlink, John R.

Published
2024
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41. Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials

Author

Kosiborod, Mikhail N, Deanfield, John, Pratley, Richard, Borlaug, Barry A, Butler, Javed, Davies, Melanie J, Emerson, Scott S, Kahn, Steven E, Kitzman, Dalane W, Lingvay, Ildiko, Mahaffey, Kenneth W, Petrie, Mark C, Plutzky, Jorge, Rasmussen, Søren, Rönnbäck, Cecilia, Shah, Sanjiv J, Verma, Subodh, Weeke, Peter E, and Lincoff, A Michael

Published
2024
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42. Design and rationale of a pragmatic randomized clinical trial of early dronedarone versus usual care to change and improve outcomes in persons with first-detected atrial fibrillation – the CHANGE AFIB study

Author

Pokorney, Sean D., Nemeth, Hayley, Chiswell, Karen, Albert, Christine, Allyn, Nadine, Blanco, Rosalia, Butler, Javed, Calkins, Hugh, Elkind, Mitchell S.V., Fonarow, Gregg C., Fontaine, John M., Frankel, David S., Fermann, Gregory J., Gale, Rex, Kalscheur, Matthew, Kirchhof, Paulus, Koren, Andrew, Miller, Joseph B., Rashkin, Jason, Russo, Andrea M., Rutan, Christine, Steinberg, Benjamin A., and Piccini, Jonathan P.

Published
2025
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44. Semaglutide in HFpEF across obesity class and by body weight reduction: a prespecified analysis of the STEP-HFpEF trial

Author

Borlaug, Barry A., Kitzman, Dalane W., Davies, Melanie J., Rasmussen, Søren, Barros, Eric, Butler, Javed, Einfeldt, Mette Nygaard, Hovingh, G. Kees, Møller, Daniél Vega, Petrie, Mark C., Shah, Sanjiv J., Verma, Subodh, Abhayaratna, Walter, Ahmed, Fozia Z., Chopra, Vijay, Ezekowitz, Justin, Fu, Michael, Ito, Hiroshi, Lelonek, Małgorzata, Melenovsky, Vojtech, Núñez, Julio, Perna, Eduardo, Schou, Morten, Senni, Michele, van der Meer, Peter, Von Lewinski, Dirk, Wolf, Dennis, and Kosiborod, Mikhail N.

Published
2023
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45. Hospitalization of Symptomatic Patients With Heart Failure and Moderate to Severe Functional Mitral Regurgitation Treated With MitraClip: Insights From RESHAPE-HF2

Author

Ponikowski, Piotr, Friede, Tim, von Bardeleben, Ralph Stephan, Butler, Javed, Shahzeb Khan, Muhammad, Diek, Monika, Heinrich, Jutta, Geyer, Martin, Placzek, Marius, Ferrari, Roberto, Abraham, William T., Alfieri, Ottavio, Auricchio, Angelo, Bayes-Genis, Antoni, Cleland, John G.F., Filippatos, Gerasimos, Gustafsson, Finn, Haverkamp, Wilhelm, Kelm, Malte, Kuck, Karl-Heinz, Landmesser, Ulf, Maggioni, Aldo P., Metra, Marco, Ninios, Vlasis, Petrie, Mark C., Rassaf, Tienush, Ruschitzka, Frank, Schäfer, Ulrich, Schulze, P. Christian, Spargias, Konstantinos, Vahanian, Alec, Zamorano, Jose Luis, Zeiher, Andreas, Karakas, Mahir, Koehler, Friedrich, Lainscak, Mitja, Öner, Alper, Mezilis, Nikolaos, Theofilogiannakos, Efstratios K., Ninios, Ilias, Chrissoheris, Michael, Kourkoveli, Panagiota, Papadopoulos, Konstantinos, Smolka, Grzegorz, Wojakowski, Wojciech, Reczuch, Krzysztof, Pinto, Fausto J., Wiewiórka, Łukasz, Streb, Witold, Adamo, Marianna, Santiago-Vacas, Evelyn, Friedrich Ruf, Tobias, Gross, Michael, Tongers, Joern, Hasenfuß, Gerd, Schillinger, Wolfgang, and Anker, Stefan D.

Published
2024
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47. Patiromer for Heart Failure Medication Optimization in Patients With Current or Past Hyperkalemia: DIAMOND Subanalysis

Author

Coats, Andrew J.S., Anker, Stefan D., Lund, Lars H., Filippatos, Gerasimos, Rossignol, Patrick, Pitt, Bertram, Weir, Matthew R., Kosiborod, Mikhail N., Metra, Marco, Böhm, Michael, Ezekowitz, Justin A., Bayes-Genis, Antoni, Mentz, Robert J., Ponikowski, Piotr, Senni, Michele, Cleland, John G.F., Goudev, Assen, Khintibidze, Irakli, Lindenfeld, Joann, Merkely, Bela, Waechter, Sandra, Budden, Jeffrey, Perrin, Amandine, and Butler, Javed

Published
2024
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50. Cardiovascular Safety Reporting in Contemporary Breast Cancer Clinical Trials

Author

Hamid, Arsalan, Anker, Markus S, Ruckdeschel, John C, Khan, Muhammad Shahzeb, Tharwani, Arsal, Oshunbade, Adebamike A, Kipchumba, Rodney K, Thigpen, Samuel C, Anker, Stefan D, Fonarow, Gregg C, Hall, Michael E, and Butler, Javed

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Patient Safety, Cardiovascular, Clinical Trials and Supportive Activities, Cancer, Clinical Research, Heart Disease, Breast Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Breast Neoplasms, Female, Humans, Troponin, cancer therapy, cardio-oncology, cardiovascular disease, pharmacotherapy, safety, cardio‐oncology, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

Background Several cancer therapies have been associated with cardiovascular harm in early-phase clinical trials. However, some cardiovascular harms do not manifest until later-phase trials. To limit interdisease variability, we focused on breast cancer. Thus, we assessed the reporting of cardiovascular safety monitoring and outcomes in phase 2 and 3 contemporary breast cancer clinical trials. Methods and Results We searched Embase and Medline records for phase 2 and 3 breast cancer pharmacotherapy trials. We examined exclusion criterion as a result of cardiovascular conditions, adverse cardiovascular event reporting, and cardiovascular safety assessment through cardiovascular imaging, ECG, troponin, or natriuretic peptides. Fisher's exact test was utilized to compare reporting. Fifty clinical trials were included in our study. Patients were excluded because of cardiovascular conditions in 42 (84%) trials. Heart failure was a frequent exclusion criterion (n=31; 62% trials). Adverse cardiovascular events were reported in 43 (86%) trials. Cardiovascular safety assessments were not reported in 23 (46%) trials, whereas natriuretic peptide and troponin assessments were not reported in any trial. Cardiovascular safety assessments were more frequently reported in industry-funded trials (69.2% versus 0.0%; P

Published
2022

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