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
Gustavo A Heresi, MD, MS
Lead sponsor
The Cleveland Clinic
Sponsor institution
The Cleveland Clinic
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator