NCT05493371

Empagliflozin in Pulmonary Arterial Hypertension

Feasibility Study of Empagliflozin As Treatment for Idiopathic Pulmonary Arterial Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to determine whether conducting a randomized placebo-controlled clinical trial is feasible, safe for the patient and whether the treatment is well tolerated in patients with idiopathic pulmonary arterial hypertension.

Detailed description

This study is designed as a prospective, single-center, phase IIa, single-arm, open-label, interventional proof-of-concept trial in patients diagnosed with idiopathic pulmonary arterial hypertension (IPAH) who are currently on stable therapy. Patients will be administered a once-daily oral dose of 10 mg empagliflozin for a duration of 12 weeks along with standard treatment. The primary objective of this study is to assess safety and tolerability of empagliflozin and to assess whether a potential future randomized, double-blind, placebo-controlled study is feasible.

Conditions

• Idiopathic Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Empagliflozin 10 MG	10 mg once daily empagliflozin oral tablets for 12 weeks

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2022-08-09
• Last updated: 2024-11-20

Locations

1 site across 1 country: Netherlands