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Metoprolol and Genetics in Heart Failure with Reduced Ejection Fraction

This study is looking at how a common heart medication called metoprolol succinate works in people with a type of heart failure called Heart Failure with Reduced Ejection Fraction (HFrEF). Researchers want to understand if a person's genetics, specifically their "beta-blocker polygenic score," affects how well metoprolol works for them. Participants will receive metoprolol succinate daily, with the dose gradually increased over 6-12 weeks, and then continued for several months. The study aims to see if people with a high polygenic score have weaker responses to metoprolol or lower levels of the drug in their blood compared to those with a low polygenic score. You may be able to join if you have HFrEF and haven't taken a beta-blocker recently. The study plans to enroll 100 people, but its current status is unclear.

Study design
This is an interventional study planning to enroll 100 participants. It compares how metoprolol succinate works in HFrEF patients grouped by their beta-blocker polygenic score.
What's involved
Participants will take metoprolol succinate daily, with the dose adjusted over 6-12 weeks, and then continue treatment for approximately 5-8 months. If you don't have existing genetic data, a DNA sample will be taken.
Compensation
Not stated in the trial record.
Follow-up
The main measurement of success is taken from the start of the study to approximately 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07490067

Mechanistic Clinical Trial Comparing the Pharmacokinetics/Pharmacodynamics of Metoprolol in Heart Failure With Reduced Ejection Fraction Patients With Low vs. High Polygenic Score

Recruiting
PHASE4Ages 18+InterventionalTreatment
University of Michigan
~100 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:Metoprolol SuccinateBeta-Blocker Polygenic ScoreIllumina Infinium Global Diversity Array with Enhanced Pharmacogenomics (PGx)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Half Maximal Effective Concentration of Change in Exercise-Induced Heart Rate (EC50 of ΔEIHR)
Measured over Baseline to approximately 6 months

Conditions

Heart Failure With Reduced Ejection Fraction

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Heart failure with reduced ejection fraction

NCT07490067

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Michigan

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jasmine Luzum, PharmD, PhD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Diamond Thomas
[email protected]
734-615-4532
Email the study team

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Eligibility criteria

Inclusion

Heart Failure with Reduced Ejection Fraction (HFrEF)
Has not taken a beta-blocker within the past 6 months (preferred), or if needed to meet enrollment target, patients that have not taken a beta-blocker in the past 3 months, or only taken a low dose of beta-blocker within the past 6 months (i.e., \< 50% of the guideline-recommended HFrEF target dose, or for beta-blockers that are not approved for HFrEF, \<50% of the maximum dose)
Genetic data already available to calculate the polygenic score (e.g., through participation in the Michigan Genomics Initiative (MGI) or other genetic tests) or willingness to provide a deoxyribonucleic acid (DNA) sample for genetic analysis
White race
Has been prescribed a stable dose (including no dose) of angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), ARB-neprilysin inhibitor (ARNI), sodium-glucose cotransporter 2 (SGLT-2) inhibitor, or mineralocorticoid receptor antagonist (MRA) for at least the past 4 weeks
Has been prescribed a stable dose (including no dose) of diuretic(s) for at least the past 2 weeks
For women of child-bearing potential: the participant is willing to perform a pregnancy test and use a highly effective contraceptive method for at least 4 weeks prior to the start of metoprolol treatment, during the entire metoprolol treatment period, and for at least 5 days after the discontinuation of metoprolol treatment
Ability to understand and willing to sign a written informed consent

Exclusion

Prior heart transplant or left ventricular assist device (LVAD) or planned within treatment period
Planned implantation of a pacemaker or Cardiac Resynchronization Therapy (CRT) during treatment period
Patients with a pacemaker that does not allow their heart rate to change in response to exercise per protocol
Pregnant
Systolic blood pressure \< 95 millimeters of mercury (mmHg)
Heart rate \< 60 beats per minute
Second (Mobitz II)- or third-degree heart block
Cardiogenic shock
Patients with acute decompensated heart failure requiring current hospitalization or immediate medical intervention.
Sick sinus syndrome
Pheochromocytoma
Known hypersensitivity to the metoprolol succinate oral tablet used in the trial
Hypertrophic obstructive cardiomyopathy
Active myocarditis
Acute coronary syndrome within the past month
Active or uncorrected severe mitral or aortic valvular dysfunction
Patients with known severe congenital heart disease per protocol
Child-Pugh Class C liver disease
Patients with end-stage renal disease (ESRD) requiring hemodialysis
Concomitant disease that prohibits participating in Cardiopulmonary Exercise Test (CPET) per protocol
Concomitant disease with expected survival less than the duration of the study (e.g., metastatic cancer)
Current or planned treatment with cardiotoxic medications, including interferons and the cancer therapies per protocol
Concurrent participation in another clinical trial that may affect participant safety or validity of data collected in this clinical trial
Inability to take oral medication
Unwilling or unlikely to adhere to the study procedures, as determined at the discretion of the study team, including but not limited to the following reasons:

What this trial measures

  • Half Maximal Effective Concentration of Change in Exercise-Induced Heart Rate (EC50 of ΔEIHR)Baseline to approximately 6 months

    The plasma concentration of s-metoprolol succinate that causes 50% of the change in exercise-induced heart rate.