Metformin for Pulmonary Hypertension
(PH-HFpEF Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMichael Risbano, MD, MA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of California, San Francisco

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The main objective of this study is to determine the clinical efficacy of metformin versus placebo and the therapeutic response with regards to functional capacity and hemodynamics in PH-HFpEF.

Research Team

Michael Risbano, MD, MA

Principal Investigator

University of Pittsburgh

Marc A Simon, MD, MS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults with PH-HFpEF, a type of heart failure with high blood pressure in the lungs. Participants must have been diagnosed within the last 6 months and show at least three signs of metabolic syndrome. People under 18, those with uncontrolled hypertension or very low blood pressure, severe diabetes, recent major heart events, certain chronic diseases, or who are pregnant/breastfeeding cannot join.

Inclusion Criteria

You have three or more signs of metabolic syndrome as defined.

I was diagnosed with heart failure with preserved ejection fraction by a heart cath test in the last 6 months.

Exclusion Criteria

You are currently smoking cigarettes.

Your hemoglobin A1C level is higher than 10.

You are pregnant or breastfeeding.

See 15 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive metformin or placebo to assess efficacy on exercise hemodynamics and functional capacity

12 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Metformin (Biguanide)
Placebo oral capsule (Drug)

Trial OverviewThe study aims to see if Metformin can improve how well the heart and lungs work in people with PH-HFpEF compared to a placebo (a pill without any medicine). Patients will be randomly assigned to either receive Metformin or the placebo while their functional capacity and hemodynamics (blood flow) are monitored.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Drug: MetforminExperimental Treatment1 Intervention

500mg PO (by mouth) BID (two times daily) x 1 week then increase to 1000mg PO BID x 11 weeks

Group II: Placebo Oral CapsulePlacebo Group1 Intervention

Placebo capsule that is of identical size, shape, and color to experimental drug capsule PO (by mouth) BID (two times each day) for 12 weeks

Metformin is already approved in Canada, Japan, China, Switzerland for the following indications: