Deprescribing Beta-Blockers for Diastolic Heart Failure
(DEPRESCRIBE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether stopping beta-blockers, a medication used for heart conditions, can help older adults with heart failure with preserved ejection fraction (HFpEF) feel and function better. Participants will either gradually stop taking beta-blockers or continue with their usual dosage to determine if symptoms and quality of life improve. It suits individuals aged 60 and above who have been hospitalized for heart failure in the last two years and are currently taking beta-blockers like atenolol or metoprolol. Participants will engage in the study for about four months, with regular check-ins and medication monitoring. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how it can benefit more patients.
Will I have to stop taking my current medications?
If you are in the deprescribing group, you will gradually stop taking beta-blockers under guidance. If you are in the usual care group, you will continue taking your beta-blockers as usual.
What is the safety track record for beta-blockers?
Research shows that beta-blockers are generally safe for people with heart conditions, including those with preserved ejection fraction heart failure (HFpEF). Studies have found that beta-blockers can lower the risk of death in some heart failure patients, but their specific effects on HFpEF remain less understood.
Beta-blockers are usually well-tolerated, meaning most people can take them without major problems. Common side effects might include fatigue or dizziness, but serious issues are rare. Monitoring blood pressure and heart rate is important, as beta-blockers can affect these.
This study involves no new or experimental drugs. The trial focuses on "deprescribing," which means carefully stopping the medication. This process is expected to be safe. Participants will gradually reduce their beta-blocker dose under close supervision. This ensures safety while researchers study how stopping the medication affects health.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about this trial because it explores a new approach to managing diastolic heart failure by deprescribing beta-blockers. Unlike traditional treatments that maintain or increase the use of beta-blockers, this trial investigates the effects of gradually reducing and eventually discontinuing them. The goal is to understand if reducing reliance on beta-blockers can improve symptoms or quality of life for patients, potentially offering a new perspective on managing this form of heart failure. This approach could redefine how beta-blockers are used in treatment, especially when their benefits might not always outweigh the side effects.
What evidence suggests that deprescribing beta-blockers could be effective for diastolic heart failure?
Research has shown mixed results regarding the effectiveness of beta-blockers for individuals with heart failure with preserved ejection fraction (HFpEF). Some studies suggest that beta-blockers might not extend the lifespan of these patients and could increase their risk of hospitalization. Other research indicates that patients with better heart pumping ability might experience a lower quality of life on beta-blockers. This trial will compare two approaches: one group of participants will gradually replace their beta-blocker with placebo pills, while another group will continue their beta-blocker at the usual dose. Overall, while beta-blockers benefit some types of heart failure, their advantages for HFpEF remain unclear.12356
Who Is on the Research Team?
Parag Goyal, MD, MSc
Principal Investigator
Weill Medical College of Cornell University
Andrew Ambrosy, MD, MPH
Principal Investigator
Kaiser Permanente
Are You a Good Fit for This Trial?
This trial is for ambulatory adults aged 60 or older with heart failure with preserved ejection fraction (HFpEF), who have been hospitalized for heart failure in the last two years and are currently taking specific beta-blockers. Participants must be members of Kaiser Permanence Northern California.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take study medicine for about 4 months, with blood pressure and heart rate monitored, and complete regular phone calls and questionnaires
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Beta-blockers
Trial Overview
The study aims to determine if stopping beta-blockers can improve symptoms and quality of life in elders with HFpEF. It involves a deprescribing group, where doses are gradually reduced, versus a usual care group that continues regular doses, over approximately four months.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Participants will continue their beta-blocker at their usual dose in capsules that look identical to those used for the deprescribe arm.
Participants will have their beta-blocker replaced with pills that have decreasing amounts of beta-blocker until they are completely off their medicine and taking placebo pills.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
Kaiser Foundation Research Institute
Collaborator
National Institute on Aging (NIA)
Collaborator
Citations
Beta-blocker therapy in heart failure with preserved ...
Conclusion: This meta-analysis showed that beta-blocker therapy has the potential to reduce all-cause mortality in patients with HFpEF based on ...
Beta-Blocker Use and Heart Failure Outcomes in Mildly ...
Beta-blockers were associated with decreased risk of HF hospitalization and death in patients with HFmrEF but a lack of survival benefit and a higher risk of ...
Uncertainties About Use of β-Blockers in HFpEF
Among patients who received β-blockers, those with higher EF (≥65%) had lower KCCQ-OS scores (mean difference, −6.1 points [95% CI, −12.3 to 0.0 ...
Beta-blocker therapy in heart failure with preserved ...
This meta-analysis showed that beta-blocker therapy has the potential to reduce all-cause mortality in patients with HFpEF based on observational studies.
Association Between β-Blocker Use and Mortality/Morbidity ...
Among patients with HFrEF, β-blocker use was associated with lower risk of death (adjusted hazard ratio 0.85 [95% CI, 0.75–0.96]) and ...
Association of β-Blocker Use With Heart Failure ...
β-Blockers are prescribed to most patients with heart failure (HF) with a preserved ejection fraction (HFpEF), but their effect on HFpEF remains ...
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