Carvedilol vs Metoprolol for Heart Failure

(CARVTOP-ICD Trial)

Recruiting at 12 trial locations

Overseen By Mehmet Aktas, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Rochester

Must be taking: Metoprolol succinate

Must not be taking: Other beta-blockers

Disqualifiers: Low blood pressure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Up to 3 years

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two medicines, carvedilol and metoprolol succinate, to determine which is more effective for treating heart failure in individuals with an implantable cardioverter defibrillator (ICD). Participants will either continue with metoprolol or switch to carvedilol, and the trial will monitor the effects on heart issues, hospital visits, and overall quality of life. It targets individuals currently taking metoprolol, who have heart failure with reduced ejection fraction (indicating the heart doesn't pump well), and possess an ICD. As a Phase 4 trial, this research involves FDA-approved treatments and aims to understand their benefits for a broader patient population, offering valuable insights for those with heart failure.

Will I have to stop taking my current medications?

Yes, you will need to stop taking metoprolol succinate and switch to carvedilol if you join this trial.

What is the safety track record for carvedilol and metoprolol succinate?

Research has shown that carvedilol is generally safe for people with heart failure. Studies have found that it improves heart function and reduces the risk of worsening heart problems. In trials, even those with severe heart failure tolerated carvedilol well. Some patients experienced mild side effects, but these were usually manageable.

Metoprolol succinate has been safely used for heart failure for a long time, and people generally tolerate it well. Side effects can occur but are usually minor.

Both carvedilol and metoprolol succinate have been widely used by people with heart issues, and their safety is well understood. Thus, both treatments are considered safe options for managing heart failure. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Carvedilol is unique because it offers a different approach in the management of heart failure compared to standard treatments like metoprolol succinate. While both are beta-blockers, carvedilol stands out by blocking multiple receptors, including alpha-1, which can lead to additional benefits in reducing blood pressure and potentially improving heart function. Researchers are excited about carvedilol because it may offer superior protection against cardiovascular events in heart failure patients, especially those with an implantable cardioverter defibrillator (ICD). This broader mechanism of action could mean better outcomes for patients at risk of serious heart-related issues.

What evidence suggests that this trial's treatments could be effective for heart failure?

This trial will compare the effectiveness of Carvedilol and Metoprolol Succinate for heart failure. Research has shown that carvedilol effectively treats heart failure. One study found that patients with severe heart failure who took carvedilol had fewer hospital visits and a lower risk of heart-related issues compared to those who did not take it. Another study showed that carvedilol improved heart function in patients with heart failure from various causes, including heart disease. Research has also shown that metoprolol succinate reduces hospital visits and helps patients with heart failure live longer. Both medications are beta-blockers, which help the heart beat more regularly and lower blood pressure, benefiting heart failure patients. Participants in this trial will either continue with Metoprolol Succinate or switch to Carvedilol to assess their comparative effectiveness. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for heart failure patients with reduced ejection fraction who have an implantable cardioverter defibrillator (ICD) and are currently on metoprolol succinate but willing to switch to carvedilol. They must have had a left ventricular ejection fraction (LVEF) of less than 50% in the past year.

Inclusion Criteria

My heart's pumping ability is below 50%.

I have a heart device for prevention, with remote monitoring.

I am currently taking metoprolol and agree to switch to carvedilol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Phase

Initial phase to assess study infrastructure, recruitment, consent processes, medication switching protocols, safety, adherence, and retention

18 months

Treatment

Participants are randomized to either remain on metoprolol succinate or switch to carvedilol, with titration to maximally tolerated doses

Up to 3 years

Baseline, weeks 2 and 4, and quarterly thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment, including regular assessments such as ICD interrogations, medication adherence, healthcare utilization, and quality of life surveys

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Carvedilol
• Metoprolol Succinate

Trial Overview The CARVTOP-ICD study compares the effectiveness of two beta-blockers, carvedilol and metoprolol succinate, in managing heart failure with ICDs. Participants will be randomly assigned to one of the drugs and monitored for up to three years for ICD therapy events, hospitalizations, or cardiovascular death.

How Is the Trial Designed?

Group I: Carvedilol Group Experimental Treatment 1 Intervention

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.

Group II: Metoprolol Succinate Group Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9330125/

Safety and efficacy of carvedilol in severe heart failure. The ... Methods and results: One hundred thirty-one patients with severe congestive heart failure were enrolled into a double-blind, placebo-controlled study of the ...

2. acc.org acc.org/Latest-in-Cardiology/Journal-Scans/2025/05/20/18/10/CATHEDRAL-HF

CATHEDRAL-HF: Is Carvedilol Effective as Monotherapy in ... Withdrawal of other heart failure treatment while maintaining carvedilol as a single therapy did not worsen left ventricular (LV) function compared to usual ...

3. ahajournals.org ahajournals.org/doi/10.1161/01.CIR.94.11.2793

Double-Blind, Placebo-Controlled Study of the Effects ... The effects of the drug were similar in patients with ischemic heart disease or idiopathic dilated cardiomyopathy as the cause of heart failure. Conclusions ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1071916498902330

Efficacy and safety of carvedilol in patients with chronic ... Randomised, placebo-controlled trial of carvedilol in patients with congestive heart failure due to ischaemic heart disease. Lancet. (1997). There are more ...

5. jacc.org jacc.org/doi/10.1016/S0735-1097%2801%2901190-1

Influence of carvedilol on hospitalizations in heart failure CABG = coronary artery bypass grafting; CHF = congestive heart failure; DC = direct current; PTCA = percutaneous transluminal coronary angioplasty. Effect of ...

6. nejm.org nejm.org/doi/full/10.1056/NEJM200105313442201

Effect of Carvedilol on Survival in Severe Chronic Heart ... Carvedilol has been shown to improve symptoms and reduce the risk of disease progression in patients with mild-to-moderate heart failure.

7. ahajournals.org ahajournals.org/doi/10.1161/01.CIR.94.11.2807

Carvedilol Produces Dose-Related Improvements in Left ... Conclusions In subjects with mild to moderate heart failure from systolic dysfunction, carvedilol produced dose-related improvements in LV function and dose- ...

8. onlinejcf.com onlinejcf.com/article/S1071-9164(97)90013-0/fulltext

Safety and efficacy of carvedilol in severe heart failure 15. CIBIS Investigators and Committees. A randomized trial of β-blockade in heart failure: the Cardiac Insufficiency Bisoprolol Study (CIBIS). Circulation ...