Metformin for Pulmonary Hypertension

(PH-HFpEF Trial)

Recruiting at 1 trial location

Overseen By Miranda Gilbert, BS, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Francisco

Must not be taking: Metformin

Disqualifiers: Uncontrolled hypertension, Type 1 diabetes, Dementia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

10 Participants Needed

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.

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
• Placebo oral capsule

Trial Overview The 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

Group I: Drug: Metformin Experimental Treatment 1 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 Capsule Placebo Group 1 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 European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Glucophage for:

• Type 2 diabetes

Approved in United States as Glucophage for:

• Type 2 diabetes

Approved in Canada as Glucophage for:

• Type 2 diabetes

Approved in Japan as Glucophage for:

• Type 2 diabetes

Approved in China as Glucophage for:

• Type 2 diabetes

Approved in Switzerland as Glucophage for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+