Metformin for Pulmonary Hypertension HFpEF

Description

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 Overview

Study Details

Study overview

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.

Phase II Trial of Metformin for Pulmonary Hypertension in Heart Failure With Preserved Ejection Fraction

Metformin for Pulmonary Hypertension HFpEF

Condition
Pulmonary Hypertension
Intervention / Treatment

-

Contacts and Locations

San Francisco

UCSF Medical Center, San Francisco, California, United States, 94143

Pittsburgh

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 2. PH-HFpEF Confirmed diagnosis by RHC within the past 6 months:
  • 3. Three or more features of metabolic syndrome defined as:
  • 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Francisco,

Michael Risbano, MD, MA, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Marc A Simon, MD, MS, STUDY_DIRECTOR, University of California, San Francisco

Study Record Dates

2024-09