20 Participants Needed

Beta Blockers for Heart Failure

(PRE-INFORMED Trial)

PO
PG
Overseen ByParag Goyal, MD, MSc
Age: 65+
Sex: Any
Trial Phase: Phase 4
Sponsor: Weill Medical College of Cornell University
Must be taking: Beta-blockers
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

Investigators will determine whether N-of-1 trials, as a pragmatic, participant-centered approach to medication optimization that can overcome key barriers of deprescribing, can lead to increased participant confidence regarding their preference to continue or discontinue beta-blockers in older adults with Heart Failure with Preserved Ejection Fraction (HFpEF).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it focuses on whether to continue or stop beta-blockers. It seems you will need to be on a beta-blocker to participate.

Is it safe to use beta blockers for heart failure?

Beta blockers like metoprolol, bisoprolol, and carvedilol are generally safe with a low risk of serious side effects when used properly, although they can sometimes cause issues like slow heart rate or breathing problems. Large studies have shown they improve survival and symptoms in heart failure patients.12345

What makes beta blockers unique for treating heart failure?

Beta blockers like carvedilol, metoprolol, bisoprolol, and nebivolol are unique because they improve survival and symptoms in heart failure by blocking certain receptors in the heart, which helps it pump more efficiently. Carvedilol also blocks additional receptors, offering broader benefits compared to some other beta blockers.26789

What evidence supports the effectiveness of beta-blocker drugs for heart failure?

Research shows that beta-blocker drugs like carvedilol, metoprolol, and bisoprolol improve survival and reduce symptoms in patients with heart failure. These drugs help patients feel better and reduce hospital visits, making them effective for managing heart failure.210111213

Who Is on the Research Team?

PG

Parag Goyal, MD, MSc

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults aged 65 or older with Heart Failure with Preserved Ejection Fraction (HFpEF), who are currently taking beta-blockers and meet specific heart function criteria. People can't join if they have other heart conditions, recent severe cardiac events, certain arrhythmias, uncontrolled blood pressure, or any instability that could affect the study.

Inclusion Criteria

I am 65 or older with heart failure but my heart still pumps well.
I am currently taking a beta-blocker medication.

Exclusion Criteria

I have had a heart attack or heart surgery in the last 3 years.
My heart condition is not caused by severe valve issues, constrictive pericarditis, high output failure, or infiltrative cardiomyopathy.
I have had episodes of very fast heartbeats.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a two-arm crossover withdrawal/reversal design with up to 6 periods, each lasting up to 6 weeks, involving titration of beta-blockers

12-36 weeks
Multiple visits as per participant's choice of 2-6 periods

Follow-up

Participants are monitored for safety and effectiveness after treatment, with qualitative interviews conducted to assess confidence and decision-making

up to 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Beta blocker
Trial Overview The study aims to see if N-of-1 trials help patients decide whether to continue or stop using beta-blockers for HFpEF by increasing their confidence in the decision-making process.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Beta-Blocker ABAB SequenceActive Control1 Intervention
Group II: Beta-Blocker BABA SequenceActive Control1 Intervention

Beta blocker is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

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Approved in European Union as Beta blockers for:
🇺🇸
Approved in United States as Beta blockers for:
🇨🇦
Approved in Canada as Beta blockers for:
🇯🇵
Approved in Japan as Beta blockers for:
🇨🇳
Approved in China as Beta blockers for:
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Approved in Switzerland as Beta blockers for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Published Research Related to This Trial

In a study of 29 heart failure patients, replacing carvedilol with propranolol did not worsen heart function, as measured by ejection fraction, after 6 months, indicating that propranolol can be a safe alternative.
The study found that propranolol led to a significant increase in ejection fraction, suggesting it may be effective in improving heart function in patients previously stabilized on carvedilol.
Replacement of carvedilol for propranolol in patients with heart failure.Marques, F., Castro, RB., Nobre, F., et al.[2019]
Beta-adrenergic receptor blockers, such as bisoprolol, metoprolol, and carvedilol, have been proven to significantly improve survival rates and reduce hospitalization in heart failure patients, leading to better overall patient well-being.
While investigational beta-blocker bucindolol showed only mild improvements in survival, the differences in properties among beta-blockers, such as selectivity and vasodilation effects, remain to be fully understood in terms of their impact on treatment outcomes.
Are all beta-blockers the same for chronic heart failure?Gottlieb, SS.[2019]
Bisoprolol has been proven to significantly reduce all-cause mortality and sudden death in patients with chronic heart failure, as shown in the CIBIS-II trial, where mortality rates were 11.8% for bisoprolol compared to 17.3% for placebo.
Recent studies, including CIBIS-III, confirm that bisoprolol is as effective and safe as enalapril for initiating heart failure treatment, with a potential survival advantage, solidifying its role alongside other beta-blockers in heart failure management.
Bisoprolol in the treatment of chronic heart failure: from pathophysiology to clinical pharmacology and trial results.Metra, M., Nodari, S., Bordonali, T., et al.[2021]

Citations

Replacement of carvedilol for propranolol in patients with heart failure. [2019]
Are all beta-blockers the same for chronic heart failure? [2019]
Bisoprolol in the treatment of chronic heart failure: from pathophysiology to clinical pharmacology and trial results. [2021]
Beta-blockade in heart failure: selective versus nonselective agents. [2018]
Beta-blockers in heart failure: are pharmacological differences clinically important? [2018]
Role of Metoprolol Succinate in the Treatment of Heart Failure and Atrial Fibrillation: A Systematic Review. [2021]
[Endothelial dysfunction: role of vasodilating betablockers in hypertension and chronic heart failure]. [2010]
[Differential therapy with beta blockers. What is their value, what are the risks?]. [2017]
The large-scale placebo-controlled beta-blocker studies in systolic heart failure revisited: results from CIBIS-II, COPERNICUS and SENIORS-SHF compared with stratified subsets from MERIT-HF. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Using beta-blockers to treat heart failure. [2016]
Effects of nebivolol versus carvedilol on left ventricular function in patients with chronic heart failure and reduced left ventricular systolic function. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Effects of metoprolol and carvedilol on cause-specific mortality and morbidity in patients with chronic heart failure--COMET. [2018]
Multiparametric comparison of CARvedilol, vs. NEbivolol, vs. BIsoprolol in moderate heart failure: the CARNEBI trial. [2022]
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