Beta-Blockers for Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a personalized approach to determine the optimal dose of beta-blockers for individuals with heart failure, specifically when the heart's pumping ability is reduced. The goal is to identify the highest tolerable dose without causing adverse effects. Participants will assess their well-being on various doses and decide whether to increase the dose. The study seeks individuals diagnosed with heart failure with reduced pumping ability who are currently taking less than half of the recommended beta-blocker dose. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance personalized treatment strategies for heart failure.
What prior data suggests that this N-of-1 trial design is safe for identifying beta-blocker doses in heart failure patients?
Research has shown that beta-blockers, like those used in this trial, are generally safe and effective for people with heart failure. Studies have found that beta-blockers can significantly lower the risk of death in these patients. For example, one study found a 26% reduction in death rates for heart failure patients using beta-blockers.
Additionally, research suggests that beta-blockers are well-tolerated when started early, with only mild and manageable side effects. Another study confirmed no significant increase in serious health issues, such as heart attacks, when using beta-blockers.
Overall, beta-blockers are considered helpful and safe for heart failure patients, especially those whose hearts pump less blood than normal. These findings support the idea that beta-blockers are a reliable option for managing heart failure symptoms.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores personalized medicine through N-of-1 trials, which is quite different from the standard beta-blockers commonly used for heart failure. Unlike traditional treatments where a one-size-fits-all approach is often used, this trial allows for a personalized assessment to determine the highest tolerated dose of beta-blockers for each individual. This method could lead to more effective and tailored treatment plans, optimizing outcomes and potentially minimizing side effects. Additionally, the trial's use of a crossover withdrawal/reversal design offers a unique way to fine-tune treatments in real-time, which could revolutionize how we approach heart failure management.
What evidence suggests that this trial's treatments could be effective for heart failure?
This trial will compare two approaches for managing heart failure: N-of-1 trials and enhanced usual care. Studies have shown that beta-blockers effectively treat heart failure with reduced ejection fraction (HFrEF), significantly lowering the risk of hospital visits and death. Important research has confirmed that beta-blockers extend the lives of those with long-term heart failure. Additionally, studies suggest that higher doses of certain beta-blockers, such as carvedilol, can further reduce the chances of death and hospital visits. Overall, beta-blockers help heart failure patients live longer and healthier lives.678910
Are You a Good Fit for This Trial?
This trial is for adults aged 60 or older who have heart failure with reduced ejection fraction (LVEF less than 40%) and are currently taking less than half the recommended dose of a beta-blocker.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
N-of-1 trials using a crossover withdrawal/reversal design with 1-5 three-week periods to identify the highest tolerated beta-blocker dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Enhanced usual care
- N-of-1 trials
Trial Overview
The study compares two approaches: one group uses a personalized, step-by-step method to find their highest tolerated beta-blocker dose using patient feedback and data visualization; the other group receives enhanced usual care with regular check-ins.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
N-of-1 trials using a crossover withdrawal/reversal design will allow for 1-5 three-week periods as needed to identify the highest tolerated beta-blocker dose
We will compare the intervention to an "enhanced usual care." Our study team will not provide guidance for dose titration (this will be at physician and patient discretion); and participants will not have access to PROs or the data visualization tool. Since attention can affect outcomes, we will "enhance usual care" by conducting phone calls at the same frequency as the intervention group.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Weill Medical College of Cornell University
Collaborator
National Institute on Aging (NIA)
Collaborator
Citations
Beta-blocker use and cardiovascular event risk in patients with ...
Beta-blockers reduce the risk of hospitalization and mortality in HFrEF patients. Beta-blockers also significantly reduce recurrent myocardial ...
Beta-blockers for chronic heart failure: surviving longer but ...
Beta-blockers, as determined by four landmark placebo-controlled studies, impart a significant survival advantage to the chronic heart failure population.
Comparison of the clinical outcome of different beta‐ ...
Heart failure patients receiving high-dose carvedilol (≥50 mg daily) showed significantly lower all-cause mortality risk and hospitalization ...
4.
researchgate.net
researchgate.net/publication/383612823_Beta-blocker_use_and_outcomes_in_patients_with_heart_failure_and_mildly_reduced_and_preserved_ejection_fractionBeta-Blocker Use and Outcomes in Patients with Heart ...
A recent systematic review reported decreased all-cause mortality with β blockers therapy in HFpEF, though readmission rates remained unchanged ...
5.
facebook.com
facebook.com/amjmedicine/videos/beta-blockers-clinical-outcomes-acute-myocardial-injury/1335621668143500/Beta Blockers, Clinical Outcomes & Acute Myocardial Injury
After nearly four years, the results showed no difference in survival, repeat heart attacks, or hospitalizations. In short, the beta blockers ...
Underuse of β-blockers in heart failure and chronic obstructive ...
The mortality reduction was 36% in those patients with coronary heart disease and 26% in those with HF. Despite compelling observational data
Articles Discontinuation of β-blockers in stable patients with ...
The primary endpoint occurred in 532 (17·2%) of 3092 patients in the β-blocker discontinuation group and 500 (15·9%) of 3146 in the continuation group (hazard ...
Beta-blockers and 1-year clinical outcomes in hospitalized ...
During one year follow up, all-cause death occurred in 305 (17.3%), cardiovascular death occurred in. 203 patients (11.5%), and rehospitalizations for HF ...
Early Versus Delayed Beta-Blocker Initiation in Acute ...
Safety outcomes indicated that early initiation is well tolerated in hemodynamically stable patients, with only mild and manageable increases ...
A patient-pooled meta-analysis of randomized clinical trials
First, our results show administration of early intravenous beta-blockers was safe. Second, there was no difference in the main outcome of one-year death or MI.
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