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Biguanide

Metformin for Pulmonary Hypertension (PH-HFpEF Trial)

Phase 2
Recruiting
Led By Michael Risbano, MD, MA
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
<3 months of stable dose of PDE5i
Age less than 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial is testing whether the diabetes drug metformin can improve outcomes in people with PH-HFpEF. The study will look at how well metformin works compared to placebo and what the effects are on heart function and capacity.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Metformin may cause side effects like stomach upset, diarrhea, muscle pain, low vitamin B12 levels, and rarely lactic acidosis (a buildup of lactate in the body), which is serious but uncommon.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been on a stable dose of PDE5 inhibitors for less than 3 months.
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I am under 18 years old.
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I have type 1 diabetes.
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I have a serious heart valve problem.
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My kidney function is severely reduced.
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My blood pressure is not controlled, with readings often above 170/95 mm Hg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,788 Previous Clinical Trials
28,184,762 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,586 Previous Clinical Trials
14,900,054 Total Patients Enrolled
Marc A Simon, MD, MSStudy DirectorUniversity of California, San Francisco
~1 spots leftby Nov 2025
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