Randomized, triple-masked, parallel arm clinical trial of empagliflozin versus placebo in pulmonary arterial hypertension (PAH) participants on stable approved PAH-targeted medical therapy.
Provision of signed and dated informed consent form
Ability and stated willingness to comply with all study procedures and availability for the duration of the study
Ability to read and write in English
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
Current use of insulin, insulin secretagogues (sulfonylureas and meglitinides), lithium or an SGLT2 inhibitor
Use of an SGLT2 inhibitor within the past 3 months prior to screening
Prior documented inability to tolerate an SGLT2 inhibitor
Volume depletion, as ascertained by the site PI, at screening or baseline
Parallel
Empagliflozin 10 MG
Drug10 mg tablet once daily
Placebo
Drugmatching tablet once daily
Change in RV ejection fraction measured by CMR
RV ejection fraction measured by CMR before and after treatment
Change in Fractional Area Change (FAC) measured by echocardiography
Fractional Area Change (FAC) measured by echocardiography before and after treatment
Change in the 6-minute walk distance (6MWD)
6-minute walk distance (6MWD) before and after treatment
Change in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels
NT-proBNP before and after treatment
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.
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Gustavo A Heresi, MD, MS
Lead sponsor
The Cleveland Clinic
Sponsor institution
The Cleveland Clinic
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
