100 Participants NeededMy employer runs this trial

Metoprolol for Heart Failure

DT
Overseen ByDiamond Thomas
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Michigan
Must be taking: Ace inhibitors, Arbs, Diuretics
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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how the medication metoprolol works for people with Heart Failure with Reduced Ejection Fraction (HFrEF). Researchers aim to determine if genetics influence the response to metoprolol. Participants will provide genetic information to assess their response to the medication. This trial suits those with HFrEF who haven't recently used a beta-blocker. As a Phase 4 trial, metoprolol is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have taken a beta-blocker in the past 3 to 6 months. You should also be on a stable dose of certain heart medications like ACE inhibitors or diuretics for a few weeks before joining.

What is the safety track record for this treatment?

Research has shown that metoprolol succinate is generally safe for people with heart failure. One study found it reduced the risk of hospital visits for worsening heart failure by 19% and improved symptoms. Another study found it lowered the overall death rate by 34% in heart failure patients.

When started carefully, most people with mild to moderate heart failure can take metoprolol safely. The FDA has also approved it for treating other heart conditions, indicating it is usually well-tolerated.

Overall, metoprolol succinate maintains a good safety record for heart failure patients.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard heart failure treatments, which often include ACE inhibitors, ARBs, or diuretics, metoprolol succinate is a beta-blocker that specifically targets beta-adrenergic receptors in the heart. This helps to reduce heart rate and improve heart function over time. Researchers are excited about metoprolol succinate because it has the potential to offer more precise control over heart failure symptoms and may improve the overall outcomes for patients by specifically moderating the effects of adrenaline on the heart. Additionally, its once-daily dosing makes it convenient for patients to adhere to their treatment regimen.

What is the effectiveness track record for metoprolol succinate in treating heart failure?

Research has shown that metoprolol succinate, the treatment under study in this trial, effectively treats heart failure with reduced ejection fraction (HFrEF). Studies indicate it helps people live longer without heart-related events compared to other forms of metoprolol. Specifically, it reduces the likelihood of hospitalization for worsening heart failure by 19%. Importantly, metoprolol has reduced the overall risk of death by 34% in heart failure patients. This evidence supports its effectiveness in managing heart failure symptoms and improving patient outcomes.12467

Who Is on the Research Team?

JL

Jasmine Luzum, PharmD, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults with heart failure with reduced ejection fraction who are white, have not recently taken beta-blockers or only at low doses, and either have genetic data available or are willing to provide a DNA sample. Participants must be on stable heart failure medications and able to give consent. Women of childbearing age must use effective birth control.

Inclusion Criteria

I have not taken beta-blockers recently or only took a low dose in the past 6 months.
I have genetic data available or am willing to provide a DNA sample.
* White race
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive metoprolol succinate for approximately 6 months, stratified by polygenic score

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Metoprolol Succinate

Trial Overview

The study tests how the heart medicine metoprolol works in people with different genetic backgrounds by dividing them into groups based on their polygenic score. It looks at how genetics affect drug levels in the blood and response to treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Metoprolol succinateExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Differential Impact of Metoprolol Formulations on Heart ...

Metoprolol succinate was associated with significantly improved event-free survival compared with tartrate in both heart failure with reduced ...

Differential Impact of Metoprolol Formulations on Heart ...

Metoprolol succinate was associated with significantly improved event-free survival compared with tartrate in both heart failure with reduced ejection fraction ...

Effectiveness of Metoprolol in Improving Cardiac and Motor ...

There was no significant difference in cardiac function, motor function, QoL, or mental status with an increase in metoprolol dose. Introduction.

Effectiveness and safety of four different beta‐blockers in ...

In this study, we evaluated the effectiveness and safety of bisoprolol, metoprolol, carvedilol, and nebivolol in the treatment of chronic heart failure.

Effects of Controlled-Release Metoprolol on Total Mortality ...

Context Results from recent studies on the effects of β1-blockade in patients with heart failure demonstrated a 34% reduction in total mortality.

Metoprolol - StatPearls - NCBI Bookshelf

Metoprolol succinate also reduced the risk of hospitalization for worsening heart failure by 19% and improved the patient's symptoms and quality ...

Association of treatment with carvedilol vs metoprolol ... - HERO

The adjusted hazard ratio for carvedilol users vs metoprolol users was 0.99 (95% CI, 0.88 to 1.11), corresponding to an absolute risk difference of -0.07 (95% ...