A study that was recently launched aims to determine the tolerability of empagliflozin in patients with pulmonary arterial hypertension (PAH) and the feasibility and safety of using it in a randomized placebo-controlled clinical trial.
The prospective, phase 2a, single-center, single-arm, open-label, interventional proof-of-concept study will be conducted in 8 patients with PAH, aged 18 or more years, who are receiving stable therapy. Participants will continue to receive their standard treatment plus 10 mg of oral empagliflozin tablets once a day for 12 weeks.
The primary outcome measures of the study are the number of patients who have to discontinue treatment because of intolerability or adverse events, the time necessary to include all patients and the number of patients needed to screen, and the number of adverse events, severe adverse events, adverse events of special interest, and suspected unexpected serious adverse reactions.
Secondary outcome measures include right and left ventricular ejection fraction, right ventricular mass and fractional area change, stroke volume, tricuspid annular plane systolic excursion, estimated systolic pulmonary arterial pressure, urine safety biomarkers, functional class, 6-minute walk distance, and quality of life.
Read more about the treatment of PAH
Patients who have received or are scheduled to receive any investigational treatments within 1 month of the start or during the course of this study are not eligible to participate.
The study will be conducted at Amsterdam University Medical Center in the Netherlands. It is not yet recruiting participants, and it is estimated to start on November 1, 2022. The estimated study completion date is November 1, 2024.
Empagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used to lower blood glucose levels in patients with type 2 diabetes mellitus and reduce the risk of cardiovascular disease. Research in animal models has shown that SGLT2 inhibitors could improve right ventricular hemodynamics and pulmonary vascular remodeling in PAH and thus could provide therapeutic benefits in these patients.
Empagliflozin in pulmonary arterial hypertension (Emphower PoC). ClinicalTrials.gov. August 9, 2022. Accessed August 17, 2022.