Actively Recruiting
Mechanistic Clinical Trial Comparing the Pharmacokinetics/Pharmacodynamics of Metoprolol in Heart Failure With Reduced Ejection Fraction Patients With Low vs. High Polygenic Score
Led by University of Michigan · Updated on 2026-04-14
100
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this trial is to better understand how the beta-blocker metoprolol works in people with Heart Failure with Reduced Ejection Fraction (HFrEF) according to participants genetics. Participants will have the beta-blocker (BB) polygenic score calculated from genotype data. The score will be used to stratify the patients in the low and high polygenic score groups in the study. The hypotheses for this trial are: * HFrEF patients with high polygenic score will have weaker cardiovascular responses to metoprolol succinate than HFrEF patients with low polygenic score. * HFrEF patients with high polygenic score have lower steady-state plasma concentrations of metoprolol succinate than HFrEF patients with low polygenic score. * HFrEF patients with high polygenic score require higher metoprolol succinate plasma concentrations to achieve similar cardiovascular effects as those with low polygenic score.
CONDITIONS
Official Title
Mechanistic Clinical Trial Comparing the Pharmacokinetics/Pharmacodynamics of Metoprolol in Heart Failure With Reduced Ejection Fraction Patients With Low vs. High Polygenic Score
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Heart Failure with Reduced Ejection Fraction (HFrEF)
- Has not taken a beta-blocker within the past 6 months (preferred), or if needed, not taken one in the past 3 months or only low dose within past 6 months
- Genetic data available or willing to provide a DNA sample for analysis
- Identifies as White race
- Prescribed stable dose (including no dose) of ACE inhibitors, ARBs, ARNIs, SGLT-2 inhibitors, or MRAs for at least 4 weeks
- Prescribed stable dose (including no dose) of diuretics for at least 2 weeks
- Women of child-bearing potential willing to perform pregnancy tests and use effective contraception before, during, and shortly after metoprolol treatment
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Prior heart transplant or left ventricular assist device or planned during treatment
- Planned pacemaker or cardiac resynchronization therapy implantation during treatment
- Pacemaker that prevents heart rate changes during exercise
- Pregnant
- Systolic blood pressure below 95 mmHg
- Heart rate below 60 beats per minute
- Second- or third-degree heart block
- Cardiogenic shock
- Acute decompensated heart failure requiring hospitalization or immediate intervention
- Sick sinus syndrome
- Pheochromocytoma
- Known allergy to metoprolol succinate tablet
- Hypertrophic obstructive cardiomyopathy
- Active myocarditis
- Acute coronary syndrome within past month
- Active or severe uncorrected mitral or aortic valve problems
- Severe congenital heart disease
- Child-Pugh Class C liver disease
- End-stage renal disease requiring hemodialysis
- Diseases preventing cardiopulmonary exercise testing
- Diseases with expected survival less than study duration (e.g., metastatic cancer)
- Current or planned treatment with cardiotoxic medications like interferons or cancer therapies
- Participation in another clinical trial affecting safety or data validity
- Unable to take oral medication
- Unwilling or unlikely to follow study procedures due to psychiatric illness, substance abuse, or social/logistical issues
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
D
Diamond Thomas
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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