Dapagliflozin in Pulmonary Arterial Hypertensio

Phase 2

• Conditions: Pulmonary arterial hypertension.; Primary pulmonary hypertension; I27. 0

• Registration Number: IRCT20200209046427N2
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Age > or = 18
PAH, class of 1 & 4 based on guideline
In the case of group 4 PH, the patient should not be candidate for endarterectomy or balloon angioplasty during project
NYHA Functional Class >1
Clinically stable patients on pulmonary vasodilator treatment and treatment duration of at least four weeks. Clinical stability defined as stable symptoms without progression as assessed by treating clinician and without the need for unplanned hospital admissions due to worsening PAH within three months of screening.
Literacy
Informed consent

Exclusion Criteria

Allergy to SGLT2i
treatment with SGLT2i in last 6 months
PAH 2, 3, 5
eGFR <30
Severe liver dysfunction (Child-Pugh Class C)
Lung transplant candidate
Type 1 diabetes
Severe Urinary or vaginal infection

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pro- Brain natriuretic peptide (Pro-BNP). Timepoint: First day, 3 months later at the randomization time. Method of measurement: Laboratory data (Blood Sample).