A Phase 2 interventional study of Empagliflozin 10 MG and Placebo in Pulmonary Arterial Hypertension, sponsored by Gustavo A Heresi, MD, MS. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Gustavo A Heresi, MD, MS · Phase 2, Interventional, and Treatment
Randomized, triple-masked, parallel arm clinical trial of empagliflozin versus placebo in pulmonary arterial hypertension (PAH) participants on stable approved PAH-targeted medical therapy.
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.
761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's planned enrollment of 78 is above the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →This is the only study on the registry with Gustavo A Heresi, MD, MS as lead sponsor.
Counted across the registry records on this site, refreshed daily.
In order to be eligible to participate in this study, an individual must meet all the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Participants receive Empagliflozin 10 mg orally once daily for 24 weeks. Empagliflozin is over-encapsulated to match placebo.
Drug: Empagliflozin 10 MG
Participants receive placebo tablet over-encapsulated to match Empagliflozin orally once daily for 24 weeks.
Drug: Placebo
10 mg tablet once daily
Also known as: Jardiance
matching tablet once daily
Change in RV ejection fraction measured by CMR
RV ejection fraction measured by CMR before and after treatment
Time frame: 24 weeks
Change in Fractional Area Change (FAC) measured by echocardiography
Fractional Area Change (FAC) measured by echocardiography before and after treatment
Time frame: 24 weeks
Change in the 6-minute walk distance (6MWD)
6-minute walk distance (6MWD) before and after treatment
Time frame: 24 weeks
Change in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels
NT-proBNP before and after treatment
Time frame: 24 weeks
Time to clinical worsening
Composite endpoint defined as the occurrence of death, listing for lung or heart-lung transplantation, initiation of an additional PAH-targeted medication or increase in the prostacyclin dose by ≥10% due to PAH clinical worsening judged by the treating PAH clinician, atrial septostomy, hospitalization ≥ 24 hours for worsening of PAH, or functional deterioration defined by both a worsened NYHA functional class and a decrease in 6-minute walk distance by ≥15% from baseline.
Time frame: 24 weeks
Change in Multicomponent improvement
Percentage of participants meeting all three of the following criteria at the end of the study: any improvement in NYHA class or maintenance of class I-II, increase in 6-minute walk distance by at least 30 meters, decrease in NT-proBNP by at least 30%.
Time frame: 24 weeks
Change in French risk score
Proportion of participants meeting all three low-risk criteria at the end of the study: NYHA class I or II, 6-minute walk distance \> 440 meters, and NT-proBNP \< 300 pg/ml at Week 24 versus baseline.
Time frame: 24 weeks
Change in health-related quality of life (HRQOL)
Change in health-related quality of life (HRQOL) using participant reported outcome: the Medical Outcomes Survey Short Form-36 (SF-36) instrument Physical Health Composite (PHC) score.
Time frame: 24 weeks
Change in health-related quality of life (HRQOL)
Change in health-related quality of life (HRQOL)using participant reported outcome: the PAH-specific emPHasis-10 questionnaire.
Time frame: 24 weeks
Plan to share: Yes — After the study is completed, the de-identified, archived data will be transmitted to and stored at the NHLBI BioData Catalyst (BDC) or to the data repository designated by the NHLBI when the study ends. Data and samples could be used in research. Blood samples will be stored in the EmPATH biorepository for future studies. Some of this research might take place before the EmPATH Trial close out. The research will be approved by the Steering Committee (which includes the NHLBI). At a date agreed upon with the NIH BioLINCC, the EmPATH residual blood samples accepted for storage will be shipped to BioLINCC. After the EmPATH Trial ends, members of the PAH community including members of the EmPATH Steering Committee members may request biological samples from BioLINCC.
Supporting information: Study protocol, Sap, Icf
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