Beta-Blocker Discontinuation for Heart Failure

(HFpEF-BB Trial)

Overseen By Kai Chen, MD,PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UConn Health

Must be taking: Beta-blockers

Disqualifiers: Atrial fibrillation, Coronary artery disease, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the effects when people with heart failure and preserved ejection fraction (HFpEF) stop taking beta-blockers, a common heart medication. Researchers seek to observe changes in patients’ conditions over four weeks after discontinuing the medication. The trial is recruiting patients who have experienced heart failure with symptoms like fatigue or shortness of breath, are stable, and are currently taking beta-blockers. Participants should also have been using loop diuretics to manage fluid retention. If beta-blockers were prescribed for other heart issues, this trial is not suitable. As an unphased trial, it offers patients the opportunity to contribute to important research that could enhance heart failure management.

Do I need to stop taking my current medications for the trial?

Yes, you will need to stop taking beta-blockers for this trial, as it involves evaluating changes after beta-blocker withdrawal in heart failure patients.

What prior data suggests that beta-blocker discontinuation is safe for HFpEF patients?

Research has shown mixed results about stopping beta-blockers in heart failure patients. Beta-blockers lower heart rate and blood pressure. Some studies suggest they can reduce the risk of death and hospital visits for heart failure patients. However, these benefits are less clear for those with heart failure with preserved ejection fraction (HFpEF).

One study examined the effects of stopping beta-blockers in heart failure patients. It found that discontinuing these medications can impact exercise capacity and overall function. However, the study did not clarify the safety risks or benefits, leaving uncertainty about whether stopping beta-blockers is safe for everyone.

As this is an early-stage study, the safety of this treatment might not be fully understood yet. Participation could help doctors learn more about the effects and safety of stopping beta-blockers in similar patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about beta-blocker discontinuation for heart failure with preserved ejection fraction (HFpEF) because it challenges the current standard of care. Typically, beta-blockers are used to manage heart failure symptoms, but this approach explores the potential benefits of stopping their use in certain patients. The unique feature of this strategy is its potential to improve quality of life and reduce medication burden for HFpEF patients, who may not experience the same benefits from beta-blockers as those with other types of heart failure. By focusing on discontinuation, researchers aim to discover whether patients might actually fare better without these medications, offering a fresh perspective on heart failure management.

What evidence suggests that beta-blocker discontinuation might be an effective treatment for heart failure?

Research has shown that beta-blockers lower the risk of death and hospital visits for patients with certain types of heart failure. However, their effect on heart failure with preserved ejection fraction (HFpEF) remains unclear. Some studies suggest that as heart function improves, the benefits of beta-blockers might decrease, since beta-blockers work best when the heart's pumping ability is reduced. This trial will study HFpEF patients currently taking beta-blockers to understand the effects of continuing or stopping the medication, as the effects for these patients are still under evaluation. ^{2 3 4 6 7}

Who Is on the Research Team?

Kai Chen, MD,PhD

Principal Investigator

UConn Health

Are You a Good Fit for This Trial?

This trial is for stable heart failure patients aged 50-80 with preserved ejection fraction (EF ≥50%) and specific diastolic dysfunction. They must be on chronic loop diuretics, have NYHA Class II-III or BNP ≥100, and currently taking beta-blockers.

Inclusion Criteria

ECHO evidence of EF ≥50% and Grade 2 or 3 diastolic dysfunction

I have stable heart failure with preserved ejection fraction, and my symptoms are mild to moderate.

I am between 50 and 80 years old.

Exclusion Criteria

Heart rate > 100 bpm

Non-English speaker

I am taking beta blockers for a heart condition like atrial fibrillation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Beta-blocker discontinuation in HFpEF patients with evaluation of changes before and 4 weeks after withdrawal

4 weeks

2 visits (1 standard of care, 1 research visit)

Follow-up

Participants are monitored for changes in functional capacity and cardiac hemodynamics after beta-blocker discontinuation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Beta-blocker discontinuation

Trial Overview The study is testing the effects of stopping beta-blocker medication in patients with heart failure who have a normal amount of blood pumped from their hearts. It's a small-scale pilot study observing changes over a four-week period after discontinuation.

How Is the Trial Designed?

Group I: HFpEF patients Experimental Treatment 1 Intervention

HFpEF patient who are currently taking beta blockers

Who Is Running the Clinical Trial?

UConn Health

Lead Sponsor

Trials

218

Recruited

59,100+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838111

Uncertainties About Use of β-Blockers in Heart Failure With ... These patients have a dilated cardiomyopathy where β-blockers have unequivocal evidence of reducing mortality and HF hospitalization in multiple ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11802620/

Potential effects of beta-blockers in HFpEF - PMC It is important to keep in mind that RCTs have shown that mortality decreases as ejection fraction improves. This contrasts with heart failure ...

3. jacc.org jacc.org/doi/10.1016/j.jchf.2023.09.007

Contemporary Use and Implications of Beta-Blockers in ... This study sought to examine the contemporary use and implications of beta-blockers in patients with heart failure with mildly reduced ejection fraction ( ...

4. nature.com nature.com/articles/s41598-025-17483-3

Beta blockers linked to reduced 1-Year mortality in critically ... The efficacy of beta (β) blockers in critically ill patients with congestive heart failure (CHF) remains uncertain.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2505985?query=featured_home

Beta-Blockers after Myocardial Infarction in Patients without ... Recently, findings from CAPITAL-RCT showed that carvedilol reduced the risk of cardiac death, myocardial infarction, or heart failure (a ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05174351

Beta-blocker Discontinuation in Heart Failure With ... Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction (HFpEF-BB). ClinicalTrials.gov ID NCT05174351. Sponsor UConn Health. Information ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0735109721063166

Effect of β-Blocker Withdrawal on Functional Capacity in ... Randomized and crossover study evaluating the effect of β-blocker (BB) withdrawal on maximal functional capacity in patients with heart failure ...