Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT03629340

Metformin for Pulmonary Hypertension HFpEF

Led by University of California, San Francisco · Updated on 2025-03-10

10

Participants Needed

2

Research Sites

361 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Metformin for Pulmonary Hypertension HFpEF

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • PH-HFpEF confirmed by right heart catheterization within the past 6 months with mean pulmonary arterial pressure ≥ 25 mm Hg, pulmonary artery wedge pressure ≥ 15 mm Hg, and transpulmonary gradient ≥ 12 mm Hg
  • Or exercise measurements showing mean pulmonary arterial pressure ≥ 30 mm Hg, pulmonary artery wedge pressure ≥ 20 mm Hg, and PA calculation ≥ 3 mmHg/L/min
  • Presence of three or more features of metabolic syndrome including BMI ≥ 30 kg/m², systolic BP ≥ 130 mm Hg or diastolic BP ≥ 85 mm Hg, elevated waist circumference (>102 cm in men, >88 cm in women), fasting triglycerides over 150 mg/dl, or low HDL (<40 mg/dL in men or <50 mg/dL in women)
Not Eligible

You will not qualify if you...

  • Age less than 18 years
  • Uncontrolled systemic hypertension with systolic BP > 170 mm Hg or diastolic BP > 95 mm Hg at screening
  • Systemic sitting blood pressure < 110 mmHg systolic or < 60 mm Hg diastolic at screening
  • Hemoglobin A1C greater than 10
  • Currently taking metformin, history of intolerance to metformin, or contraindication to metformin
  • Known type 1 diabetes
  • Positive urine pregnancy test or breastfeeding
  • Ejection fraction less than 50%
  • Dementia
  • End-stage malignancy
  • Major cardiovascular event or procedure within 6 weeks prior to enrollment
  • Severe valvular disease
  • Other severe acute or chronic medical, psychiatric, or laboratory abnormalities that increase risk or interfere with study participation
  • Current smoker
  • Hemoglobin less than 9 g/dL
  • Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m²
  • Receipt of investigational product or participation in drug research within 15 days
  • Less than 3 months of stable dose of PDE5 inhibitors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

UCSF Medical Center

San Francisco, California, United States, 94143

Actively Recruiting

2

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

M

Miranda Gilbert, BS, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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