Empagliflozin to Improve Right Ventricular Function in Pulmonary Arterial Hypertension

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 current guidelines and adjudicated by the local PI
• •5. PAH confirmed by right heart catheterization in the last 5 years
• •6. RV dysfunction defined FAC ≤ 34.0% on echocardiography performed during the screening visit. In PVDOMICS, FAC has a strong correlation with CMR RV ejection fraction, and FAC \< 34% predicts a CMR RV ejection fraction \<37% with a large c-statistic of 0.9. CMR RV ejection fraction \<37% is strongly associated with increased mortality and classifies PAH as high risk under the current guidelines. We do not expect this will curtail recruitment as the mean FAC in the PVDOMICS cohort is 30 ± 10%, a population like the one that will be enrolled in this study.
• •7. On FDA-approved PAH-targeted therapy (any combination including infused prostacyclin analogues and sotatercept) with stable doses for at least 8 weeks or 24 weeks for sotatercept prior to the screening visit and no clinical plans to change this therapy
• •8. Diuretic doses stable for at least 4 weeks prior to screening. After screening, diuretic doses may be changed as directed by the site PIs and/or the treating physician.
• •9. Ability to take oral medication and willingness to adhere to the study drug regimen.
• •10. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 2 weeks after the end of study drug administration
• •11. Able to have baseline and week 24 CMR according to Imaging Core criteria, as adjudicated by the Site PI