NCT03629340

Metformin for Pulmonary Hypertension HFpEF

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a 12-week blinded cross over trial of metformin in PH-HFpEF to improve exercise hemodynamics, functional capacity, and glucose metabolism. This phase II clinical trial will provide detailed phenotyping, physiological and mechanistic data on PH-HFpEF.

Conditions

• Pulmonary Hypertension
• Heart Failure

Interventions

Type	Name	Description
DRUG	Metformin	500 mg PO BID x 1 week then increase to 1000 mg PO BID x 11 weeks
DRUG	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

Timeline

• Start date: 2019-02-26
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2018-08-14
• Last updated: 2025-03-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study