Metformin for Pulmonary Hypertension HFpEF
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:
🦠 Pulmonary Hypertension 🦠 Heart Failure
🗓️ Study Start (Actual) 26 February 2019
🗓️ Primary Completion (Estimated) September 2024
✅ Study Completion (Estimated) September 2024
👥 Enrollment (Estimated) 10
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 San Francisco, California, United States
📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 August 2018
  • First Submitted that Met QC Criteria 10 August 2018
  • First Posted 14 August 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 November 2023
  • Last Update Posted 18 November 2023
  • Last Verified November 2023