Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
NCT ID: NCT06964464
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
2000 participants
INTERVENTIONAL
2025-08-17
2031-07-01
Brief Summary
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Detailed Description
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The feasibility phase will assess study infrastructure, recruitment, consent processes, medication switching protocols, safety, adherence, and retention. A patient-centered approach, including engagement of caregivers and stakeholders, underpins this phase. Strategies to improve patient and provider participation, address barriers to beta-blocker switching, and ensure diversity in enrollment will be employed. Lessons learned will guide the full-scale study.
Eligible participants must have an ICD implanted for primary prevention of sudden cardiac death due to HFrEF (either ischemic or non-ischemic etiology), be currently treated with metoprolol succinate, and be willing to switch to carvedilol. Participants will be randomized 1:1 to either remain on metoprolol succinate or switch to an equivalent dose of carvedilol, with titration to maximally tolerated doses per protocol. Key exclusion criteria include treatment with any beta-blocker other than metoprolol succinate, systolic blood pressure \<100 mmHg, known intolerance to carvedilol, or inability to comply with the study protocol.
The primary endpoint is the first occurrence of any ICD therapy (appropriate or inappropriate), cardiovascular hospitalization, or cardiovascular death. Secondary endpoints include the burden of ICD shocks, healthcare utilization (including emergency visits and hospitalizations), and quality of life (QoL) measured by the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12), Florida Shock Anxiety Scale (FSAS), and Patient Health Questionnaire-2 (PHQ-2). Tertiary endpoints include specific analyses of ventricular tachyarrhythmias and atrial arrhythmias leading to inappropriate ICD therapies.
Participants will be followed for an average of 3 years. Assessments will be conducted at baseline, weeks 2 and 4, and quarterly thereafter. Study data will include standard of care tests such as cardiac imaging, ICD interrogations, laboratory measures (BNP/NT-proBNP, creatinine, BUN, potassium, sodium), NYHA classification, CV medication data, adverse events, protocol deviations, and patient-reported outcomes.
The study will also assess subgroup responses by sex, age, race/ethnicity, heart failure etiology (ischemic vs non-ischemic), ICD type (ICD vs CRT-D), and degree of LVEF impairment.
This PCORI-funded trial will generate robust, real-world evidence to guide clinical decision-making on beta-blocker choice in HFrEF patients with ICDs, addressing a significant gap in evidence and helping inform personalized treatment strategies to improve clinical and arrhythmic outcomes.
More information can be found at www.carvtop.org
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Metoprolol Succinate Group
Participants in this group will remain on their current treatment with metoprolol succinate. The dose of metoprolol succinate may be titrated to achieve recommended target doses as per the study protocol. The aim is to assess the outcomes associated with continued use of metoprolol succinate in patients with heart failure and an implantable cardioverter defibrillator (ICD).
Metoprolol Succinate
Metoprolol succinate is a beta-blocker used for the management of heart failure with reduced ejection fraction (HFrEF). In this study, participants in the metoprolol succinate group will remain on their current treatment regimen with metoprolol succinate. The dose will be titrated to the recommended target dose as per the study protocol. The intervention aims to evaluate the effectiveness of continued use of metoprolol succinate in patients with heart failure and an implantable cardioverter defibrillator (ICD).
Carvedilol Group
Participants in this group will switch from metoprolol succinate to carvedilol at an equivalent dose. The dose of carvedilol will be titrated to the recommended target dose as per the study protocol. The goal is to evaluate the comparative effectiveness of carvedilol compared to metoprolol succinate in reducing cardiovascular events in patients with heart failure and an ICD.
Carvedilol
Carvedilol is a non-selective beta-blocker with alpha-blocking activity used in the treatment of heart failure. In this study, participants assigned to the carvedilol group will switch from metoprolol succinate to carvedilol at an equivalent dose. The carvedilol dose will be titrated to recommended target doses according to the study protocol. This intervention aims to compare the effectiveness of carvedilol versus metoprolol succinate in improving clinical outcomes in patients with heart failure and ICDs.
Interventions
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Metoprolol Succinate
Metoprolol succinate is a beta-blocker used for the management of heart failure with reduced ejection fraction (HFrEF). In this study, participants in the metoprolol succinate group will remain on their current treatment regimen with metoprolol succinate. The dose will be titrated to the recommended target dose as per the study protocol. The intervention aims to evaluate the effectiveness of continued use of metoprolol succinate in patients with heart failure and an implantable cardioverter defibrillator (ICD).
Carvedilol
Carvedilol is a non-selective beta-blocker with alpha-blocking activity used in the treatment of heart failure. In this study, participants assigned to the carvedilol group will switch from metoprolol succinate to carvedilol at an equivalent dose. The carvedilol dose will be titrated to recommended target doses according to the study protocol. This intervention aims to compare the effectiveness of carvedilol versus metoprolol succinate in improving clinical outcomes in patients with heart failure and ICDs.
Eligibility Criteria
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Inclusion Criteria
* ICD implanted for primary prevention for HFrEF (either ICM or NICM) with remote monitoring capability
* Current treatment with metoprolol succinate and willing to switch to carvedilol
* LVEF \<50% during the past 12 months prior to consent
Exclusion Criteria
* Treatment with any other ßB than metoprolol succinate or no ßB treatment
* Known prior intolerance or contraindication to carvedilol
* Systolic blood pressure \<100 mmHg
* Enrollment in another clinical trial
* Inability or unwilling to consent
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Rochester
OTHER
Responsible Party
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Mehmet Aktas
Associate Professor - Department of Medicine, Cardiology (SMD)
Locations
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HonorHealth
Scottsdale, Arizona, United States
AdventHealth Redmond
Rome, Georgia, United States
AdventHealth Shawnee Mission
Shawnee Mission, Kansas, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Mossouri
Columbia, Missouri, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Suny Downstate
Brooklyn, New York, United States
New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
CHRISTUS Trinity Mother Frances Health System
Tyler, Texas, United States
Health University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Packer M, Coats AJ, Fowler MB, Katus HA, Krum H, Mohacsi P, Rouleau JL, Tendera M, Castaigne A, Roecker EB, Schultz MK, DeMets DL; Carvedilol Prospective Randomized Cumulative Survival Study Group. Effect of carvedilol on survival in severe chronic heart failure. N Engl J Med. 2001 May 31;344(22):1651-8. doi: 10.1056/NEJM200105313442201.
Packer M, Bristow MR, Cohn JN, Colucci WS, Fowler MB, Gilbert EM, Shusterman NH. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med. 1996 May 23;334(21):1349-55. doi: 10.1056/NEJM199605233342101.
Poole-Wilson PA, Swedberg K, Cleland JG, Di Lenarda A, Hanrath P, Komajda M, Lubsen J, Lutiger B, Metra M, Remme WJ, Torp-Pedersen C, Scherhag A, Skene A; Carvedilol Or Metoprolol European Trial Investigators. Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure in the Carvedilol Or Metoprolol European Trial (COMET): randomised controlled trial. Lancet. 2003 Jul 5;362(9377):7-13. doi: 10.1016/S0140-6736(03)13800-7.
Diamond A, Goldenberg I, Younis A, Goldenberg I, Sampath R, Kutyifa V, Chen AY, McNitt S, Polonsky B, Steinberg JS, Zareba W, Aktas MK. Effect of Carvedilol vs Metoprolol on Atrial and Ventricular Arrhythmias Among Implantable Cardioverter-Defibrillator Recipients. JACC Clin Electrophysiol. 2023 Oct;9(10):2122-2131. doi: 10.1016/j.jacep.2023.06.009. Epub 2023 Aug 30.
Ruwald MH, Abu-Zeitone A, Jons C, Ruwald AC, McNitt S, Kutyifa V, Zareba W, Moss AJ. Impact of carvedilol and metoprolol on inappropriate implantable cardioverter-defibrillator therapy: the MADIT-CRT trial (Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy). J Am Coll Cardiol. 2013 Oct 8;62(15):1343-50. doi: 10.1016/j.jacc.2013.03.087. Epub 2013 Jun 13.
Ruwald MH, Ruwald AC, Jons C, Alexis J, McNitt S, Zareba W, Moss AJ. Effect of metoprolol versus carvedilol on outcomes in MADIT-CRT (multicenter automatic defibrillator implantation trial with cardiac resynchronization therapy). J Am Coll Cardiol. 2013 Apr 9;61(14):1518-26. doi: 10.1016/j.jacc.2013.01.020.
Fiuzat M, Wojdyla D, Kitzman D, Fleg J, Keteyian SJ, Kraus WE, Pina IL, Whellan D, O'Connor CM. Relationship of beta-blocker dose with outcomes in ambulatory heart failure patients with systolic dysfunction: results from the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial. J Am Coll Cardiol. 2012 Jul 17;60(3):208-15. doi: 10.1016/j.jacc.2012.03.023. Epub 2012 May 2.
Other Identifiers
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PLACER-2023C3-33489
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00010093
Identifier Type: -
Identifier Source: org_study_id
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