Metformin for Pulmonary Hypertension HFpEF

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT03629340
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    500 mg PO BID x 1 week then increase to 1000 mg PO BID x 11 weeks
  • Placebo oral capsule — DRUG
    Placebo capsule that is of identical size, shape, and color to experimental drug capsule PO (by mouth) BID (two times each day) for 12 weeks

Study Details

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.

Key Dates

Start date
Feb 26, 2019
Status verified
Mar 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Drug: Metformin
    500mg PO (by mouth) BID (two times daily) x 1 week then increase to 1000mg PO BID x 11 weeks
  • Placebo Comparator: Placebo Oral Capsule
    Placebo capsule that is of identical size, shape, and color to experimental drug capsule PO (by mouth) BID (two times each day) for 12 weeks

Primary Outcome Measure

The primary endpoint of the trial will be mean pulmonary artery pressure (mPAP) during submaximal exercise as compared between placebo and metformin at 12 weeks (i.e. the week 12 RHC of placebo vs week 12 RHC of metformin). [ Time Frame: 12 weeks (i.e. the 12th week of placebo vs 12th week of metformin) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCSF Medical CenterSan FranciscoCalifornia94143
Miranda Gilbert
[email protected]
415-514-6351
Marc A Simon, MD, MS (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Sara Onesi, RN
[email protected]
412-864-3265
Michael Risbano, MD, MA (PRINCIPAL_INVESTIGATOR)

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