Beta Blockers for Heart Failure

(UPBEAT Trial)

Overseen By Whitney Cabral, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: David Lanfear

Must not be taking: Beta blockers

Disqualifiers: Cancer, Heart transplant, Dialysis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of beta blockers for people with heart failure who have an ejection fraction between 41% and 50%. Researchers use genetic information to determine if it affects patient response to the medication. They also monitor changes in heart size and function using MRI scans. Ideal candidates for this trial include those diagnosed with heart failure within the past year and having an ejection fraction in the specified range. As an unphased study, this trial provides a unique opportunity to enhance understanding of heart failure treatment and potentially improve future care.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking more than 25% of the target dose of beta blockers. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that beta blockers are usually well-tolerated and have FDA approval for treating heart issues such as high blood pressure and heart failure. Studies have found that beta blockers can lower the risk of death and reduce hospital stays for those with heart failure. However, one study found a higher chance of hospitalization without a clear survival benefit for some heart failure patients. Overall, beta blockers are considered safe, but like all medications, they can have side effects. Discussing personal risks with a healthcare provider is important before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Beta blockers are unique because they help the heart beat slower and with less force, which can reduce blood pressure and improve heart function in heart failure patients. Unlike other treatments for heart failure that primarily focus on removing excess fluid or dilating blood vessels, beta blockers directly target the heart's workload and can improve heart muscle function over time. Researchers are excited about this treatment because it offers a different approach by directly influencing the heart's activity and has the potential to improve long-term outcomes for patients with heart failure.

What evidence suggests that beta blockers could be effective for heart failure?

Research has shown that beta blockers can improve heart health in people with heart failure. Studies have found that these medications lower the risk of hospitalization and reduce the chances of dying from heart problems. One study found that beta blockers reduced death rates in the hospital and helped patients spend less time there. Another study showed that beta blockers decreased the risk of hospital visits and death due to heart failure in some patients. In this trial, participants will receive either a beta blocker or a placebo at random. Overall, beta blockers have proven effective in helping the heart work better and keeping patients healthier. ^{2 3 5 6 7}

Who Is on the Research Team?

David Lanfear, MD

Principal Investigator

Henry Ford Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18-89 with heart failure and an ejection fraction between 41-50%. They must have been diagnosed within the last year, not be on high doses of beta blockers, and can't have severe other conditions like current cancer treatments or end-stage renal disease. Blood pressure needs to be stable, and they shouldn't need a heart transplant soon.

Inclusion Criteria

Ejection Fraction (EF) >40% and <=50% by any modality within 1 year (must be most recent)

I am between 18 and 89 years old.

I was diagnosed with heart failure within the last year.

Exclusion Criteria

My cancer needs treatment now.

I am on dialysis or have end-stage renal disease.

Previous documented EF <= 35%

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either beta blocker or placebo, with titration according to study protocol

6 months

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Beta blocker

Trial Overview The UPBEAT study tests if genetic differences (polygenic scores) affect how well beta blocker medications work in patients with mild heart failure. It also looks at changes in the size of the left ventricle's pumping chamber using MRI scans.

How Is the Trial Designed?

Group I: Beta Blocker Experimental Treatment 1 Intervention

This group will be dispensed and titrated on beta blocker according to study protocol.

Group II: Placebo Active Control 1 Intervention

This group will be dispensed and titrated on placebo according to study protocol.

Who Is Running the Clinical Trial?

David Lanfear

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3513266/

Clinical Effectiveness of Beta-Blockers in Heart Failure Results. Observed 1-year mortality was 33%, and all-cause rehospitalization was 64%. Among 7154 patients hospitalized with heart failure and eligible for beta- ...

2. jacc.org jacc.org/doi/10.1016/j.jchf.2023.03.017

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 ...

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

Beta blockers linked to reduced 1-Year mortality in critically ... It found that β blockers therapy demonstrated benefits in reducing in-hospital mortality and hospitalization duration in ICU patients with CHF.

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/1935124

β-Blockers and Outcomes in Patients With Heart Failure ... In the main analysis, with consideration of β-blocker use at baseline only, the mortality reduction was 7%. However, unlike in RCTs, there were ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.118.005103

Comparative Effectiveness of β-Blocker Use Beyond 3 ... In this observational analysis, β-blocker use beyond 3 years post-MI, regardless of the dose achieved, was not associated with improved outcomes.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK532906/

Beta Blockers - StatPearls - NCBI Bookshelf Beta-blockers are indicated and have FDA approval for the treatment of tachycardia, hypertension, myocardial infarction, congestive heart failure, cardiac ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.120.007180

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 ...