Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05371496
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

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

Interventions

  • Semaglutide — DRUG
    3.0 mg/ml (titrated to 2.4 mg) subcutaneous once weekly for 12 months
  • Placebo — DRUG
    Matched placebo with no active drug once weekly for 12 months
  • Counselling on healthy lifestyle intervention — BEHAVIORAL
    All participants will receive counselling on healthy lifestyle intervention including limiting consumption of salt, red meat, saturated or trans fats, sweets, and sugar-sweetened beverages, and how to restrict calorie intake (500 kcal/day deficit) in consultation with a trained study dietician. Regular physical activity \>150 minutes per week will be encouraged.

Study Details

The purpose of this research is to find out if an aggressive intervention to lose weight, will improve symptoms in patients with obesity-related cardiomyopathy, which is also known as the obese phenotype of heart failure with preserved ejection fraction (HFpEF).

Key Dates

Start date
Sep 6, 2022
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
81 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Semaglutide Treatment
    Subjects will receive Semaglutide once weekly in addition to counselling on healthy lifestyle intervention
  • Placebo Comparator: Placebo Treatment
    Subjects will receive matching placebo once weekly in addition to counselling on healthy lifestyle intervention

Primary Outcome Measure

Pulmonary Capillary Wedge Pressure (PCWP) [ Time Frame: Baseline, 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Rochester, MN

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Mayo Clinic in Rochester· Rochester, MN

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