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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07490067
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metoprolol Succinate — DRUG
    Participants will be given daily metoprolol and the dose will be titrated up to 200 milligrams daily (over 6-12 weeks) or the maximum tolerated dose. Once this dose is reached treatment will continue for approximately 5-8 months. In addition, participants, will have various visits that include laboratory and cardiac testing at certain time points.
  • Beta-Blocker Polygenic Score — DEVICE
    The purpose of the beta-blocker polygenic score is to predict which HFrEF patients will respond better to beta-blocker therapy. It will be used to stratify the patients in the low and high polygenic score groups in the study. There are no post-manufacturing modifications to the score.
  • Illumina Infinium Global Diversity Array with Enhanced Pharmacogenomics (PGx) — DEVICE
    If the participant does not already have genotype data available through Michigan Genomics Initiative (MGI), then this device will be used to genotype DNA sample, which will be used to calculate the polygenic score. There are no post-manufacturing modifications to the device.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Metoprolol succinate
    Treatment will be given for approximately 6 months

Primary Outcome Measure

Half Maximal Effective Concentration of Change in Exercise-Induced Heart Rate (EC50 of ΔEIHR) [ Time Frame: Baseline to approximately 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Jamine Luzman, PharmD, PhD
[email protected]
734-615-4851
Jasmine Luzum, PharmD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
University of Michigan· Ann Arbor, MI

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