RECRUITING

Metformin for Pulmonary Hypertension HFpEF

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-02-26

Study Completion:2024-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03629340

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Imani Robinson, BS, MS

CONTACT

415-476-7600

Imani.Robinson@ucsf.edu

Principal Investigator

Michael Risbano, MD, MA

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Marc A Simon, MD, MS

STUDY_DIRECTOR

University of California, San Francisco

Study Locations (Sites)

UCSF Medical Center

San Francisco, California, 94143

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: 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

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

Study Start Date2019-02-26

Study Completion Date2024-09

Study Record Updates

Study Start Date2019-02-26

Study Completion Date2024-09

Terms related to this study

Additional Relevant MeSH Terms

Pulmonary Hypertension
Heart Failure