Understanding the Metabolic and Functional Derangement of Primary Mitral Regurgitation: a Feasibility Study Using C-11 Acetate Cardiac PET-MRI

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1

The aim of this pilot imaging study is to investigate the underlying changes in myocardial oxidative metabolism, myocardial inflammation and alterations in extracellular volume in patients with chronic compensated moderate-severe primary mitral regurgitation (PMR). The PET tracer [11C] acetate will be used to image and quantify myocardial oxygen consumption (MVO2) in hearts of the study participants. Cardiac magnetic resonance imaging (CMR) using a gadolinium-based contrast agent (GBCA) will be performed to assess for and quantify expansion of myocardial extracellular volume (ECV) and myocardial inflammation. We will enroll a total of 12 participants, nine of whom will be patients with chronic, compensated asymptomatic moderate-severe PMR evaluated at the UAB Cardiovascular Disease and Structural Valve Clinic and three normal control subjects.

Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: Accepts Healthy Volunteers

• At least 18 years of age.

• Patients with chronic, asymptomatic, compensated PMR evaluated in the UAB Structural Valve Clinic OR Normal controls identified from a normal aged matched population.

• Negative urine or serum β-human chorionic gonadotropin (hcg) test within 48 hours of [11C] acetate administration in women of childbearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.

United States
University of Alabama at Birmingham
Contact Information
Sebastian Eady
Time Frame
Start Date: June 18, 2025
Estimated Completion Date: August 31, 2028
Target number of participants: 12
Active Comparator: chronic compensated moderate-severe primary mitral regurgitation (PMR)
Active Comparator: Healthy Volunteers
Related Therapeutic Areas
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov

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