UPBEAT: Using Polygenic Scores to Guide BB Therapy in HF With Mildly Reduced EF

NCT07054489 | Recruiting

• 1 other identifier: 17427
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will use polygenic scores, a tool which describes differences in genetics, to examine effectiveness of beta blocker medication in heart failure patients with ejection fraction of 41-50 percent. The study will also assess beta blockers' effect on the changes in left ventricular end-systolic volume index by MRI.

Conditions

Heart Failure; Polygenic Score

Keywords

Beta blocker; Metoprolol

Outcome Measures

Primary Outcomes (1)

• Change in left ventricle end systolic volume index

  LVESVi, measured in mL per square meter; assessed by cardiac MRI

  Within 6 months of randomization

Secondary Outcomes (10)

• Other MRI ventricular performance characteristics: Left ventricular EF

  Baseline and within 6 months of randomization

• Other MRI ventricular performance characteristics: Left ventricular end-diastolic volume index

  Baseline and within 6 months of randomization

• Clinical effects: blood pressure

  Baseline through exit visit, an interval of approximately 6 months

• Clinical effects: Heart rate

  Baseline through exit visit, an interval of approximately 6 months

• Change in NT-proBNP levels

  Baseline and within 6 months of randomization

Study Arms (2)

Beta Blocker

EXPERIMENTAL

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

Other: Beta blocker

Placebo

NO INTERVENTION

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

Interventions

Beta blocker OTHER

Participants randomized to intervention will be dosed and titrated on beta blocker according to study protocol.

Beta Blocker

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-89 years
• Ejection Fraction (EF) \>40% and =\<50% by any modality within 1 year (must be most recent)
• Clinical diagnosis of HF within 1 year, evidenced by any one: Hospital discharge with primary or secondary HF diagnosis, ER discharge with primary diagnosis of HF, ambulatory diagnostic code for HF and diuretic use, BNP\>35 ng/L or NTproBNP \>125 ng/L at any time

You may not qualify if:

• Unable to provide informed consent
• Previous documented EF =\< 35%
• Currently on BB \>25% target dose
• Uncontrolled hypertension (systolic BP \> 180 at enrollment)
• Has contraindications to all BB or intolerance to metoprolol
• Systolic BP \< 100 or heart rate \<70
• Current cancer requiring active treatment
• Heart transplant or LVAD or expected in the next year
• Life expectancy \< 1 year for any reason
• Dialysis dependence or ESRD
• MI/ PCI/ CABG within 90 days prior to enrollment or planned in the future
• Absolute indication for BB other than heart failure (e.g. tachyarrhythmia required BB for rate control, angina)
• If PI decides for any reason participation in trial is not in best interest of the patient

Sponsors & Collaborators

• David Lanfear: lead

Study Sites (1)

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• David Lanfear, MD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Whitney Cabral, MS

CONTACT

313-949-6616; wcabral1@hfhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Staff Physician

Model Details: Randomized, double-blind, placebo-controlled, two parallel group clinical trial

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: July 8, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-03

Locations

US (1)