NCT06992440

Empagliflozin to Improve Right Ventricular Function in Pulmonary Arterial Hypertension

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Gustavo A Heresi, MD, MS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized, triple-masked, parallel arm clinical trial of empagliflozin versus placebo in pulmonary arterial hypertension (PAH) participants on stable approved PAH-targeted medical therapy.

Detailed description

The central hypothesis is that treatment with empagliflozin will improve right ventricular (RV) function and other key outcomes in patients with PAH. To test this hypothesis, the EmPATH team will conduct a multicenter Phase 2 clinical trial of empagliflozin to improve right ventricular (RV) function in pulmonary arterial hypertension (PAH). Participants will be randomized in a 1:1 ratio into two arms: empagliflozin 10 mg or matching placebo orally daily for 6 months. Randomization will be stratified by enrollment site and blocked with randomly varying block sizes. The analysis plan includes no formal interim analysis of treatment efficacy or futility.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Empagliflozin 10 MG	10 mg tablet once daily
DRUG	Placebo	matching tablet once daily

Timeline

• Start date: 2025-06-26
• Primary completion: 2030-07-01
• Completion: 2030-09-01
• First posted: 2025-05-28
• Last updated: 2025-12-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study