Could a common diabetes drug ease a type of heart failure?
NCT ID NCT03629340
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This phase 2 trial investigates whether metformin, a standard diabetes medication, can improve lung blood pressure and exercise ability in people with heart failure with preserved ejection fraction (HFpEF) and pulmonary hypertension. Participants take metformin or a placebo for 12 weeks. The study measures changes in pulmonary artery pressure during exercise to see if metformin offers a benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- metformin
- What this could lead to
- If it works, metformin could become a new, affordable treatment option for people with pulmonary hypertension related to heart failure.
- What could go wrong
- This is a small, early-phase trial, so results may not apply to everyone. Metformin can cause gastrointestinal side effects, and the drug may not improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
33 people
The number who actually took part.
- Started
-
Feb 2019
- Finished
-
Feb 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 2\. PH-HFpEF Confirmed diagnosis by RHC within the past 6 months: Mean Pulmonary Arterial Pressure (mPAP) ≥ 25 mm Hg AND Pulmonary artery wedge pressure (PAWP) ≥ 15 mm Hg AND Transpulmonary Gradient (TPG) ≥ 12 mm Hg OR Exercise measurements Mean Pulmonary Arterial Pressure (mPAP) ≥ 30 mm Hg AND Pulmonary artery wedge pressure (PAWP) ≥ 20 mm Hg AND PA calculation (change in mPAP/change in cardiac output) = ≥3 mmHg/L/min 3\. Three or more features of metabolic syndrome defined as: Body Mass Index (BMI) ≥ 30 kg/m² Systolic blood pressure (BP) ≥ 130 mm Hg and/or diastolic BP ≥ 85 mm Hg Elevated waist circumference \> 102 cm in men and \> 88 cm in women Fasting triglyceride (TG) level over 150 mg/dl High-density lipoprotein \<40 mg/dL in men or \< 50 mg/dL in women Exclusion Criteria: 1. Age less than 18 years; 2. Uncontrolled systemic hypertension based on repeated measurement of sitting systolic blood pressure \>170 mm Hg or sitting diastolic blood pressure \>95 mm Hg at Screening; 3. Systemic sitting blood pressure \< 110 mmHg systolic or \< 60 mm Hg diastolic at Screening; 4. Hemoglobin A1C \> 10; 5. Currently taking metformin or history of intolerance to metformin or contraindication to taking metformin; 6. Known type 1 diabetes 7. Positive urine pregnancy test or breastfeeding 8. Ejection Fraction \< 50% 9. Dementia; 11\. End-stage malignancy; 12. Major cardiovascular event or procedure within 6 weeks prior to enrollment; 13. Severe valvular disease; 14. Other severe acute or chronic medical, psychiatric or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study or would prevent completion of the study; 15. Current Smoker; 16. Hemoglobin \<9 g/dL; 17. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2; 18. Receipt of an investigational product or device, or participation in a drug research study within a period of 15 days 19. \<3 months of stable dose of PDE5i
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
UCSF Medical Center
San Francisco, California, 94143, United States
-
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
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