Empagliflozin to Improve Right Ventricular Function in Pulmonary Arterial Hypertension
Gustavo A Heresi, MD, MS
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * In order to be eligible to participate in this study, an individual must meet all the following criteria: 1. Provision of signed and dated informed consent form 2. Ability and stated willingness to comply with all study procedures and availability for the duration of the study 3. Ability to read and write in English 4. Male or female, aged 18 years or older, with group 1 PAH, idiopathic, heritable, associated with drugs and toxins, associated with connective tissue disease and with congenital heart disease (simple repaired or unrepaired defects) according to the…
Interventions
- DrugEmpagliflozin 10 MG
10 mg tablet once daily
- DrugPlacebo
matching tablet once daily
Locations (3)
- The Johns Hopkins HospitalBaltimore, Maryland
- Cleveland ClinicCleveland, Ohio
- Vanderbilt University Medical CenterNashville, Tennessee