IRCT20200209046427N2Not yet recruitingPhase 2
Effectiveness of Dapagliflozin on Cardiovascular Outcomes and Quality of Life in Pulmonary Arterial Hypertension Patients
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to no limit (—)
- Sex
- All
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.
- •Informed consent
Exclusion Criteria
- •Allergy to SGLT2i
- •treatment with SGLT2i in last 6 months
- •PAH 2, 3, 5
- •Severe liver dysfunction (Child-Pugh Class C)
- •Lung transplant candidate
- •Type 1 diabetes
- •Severe Urinary or vaginal infection
Investigators
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