Dapagliflozin in Pulmonary Arterial Hypertension

Effectiveness of Dapagliflozin on Cardiovascular Outcomes and Quality of Life in Pulmonary Arterial Hypertension Patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200209046427N2

Enrollment

100

Registered

2023-08-18

Start date

2023-09-23

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary arterial hypertension. Primary pulmonary hypertension

Interventions

Intervention 1: Intervention group: Dapagliflozin (Sodium-glucose co-transporter-2 (SGLT2) inhibitors with a dose of 10 mg/daily from Actover company for 3 months. Intervention 2: Control group: Plac

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
The 6-minute walk test (6MWT) test. Timepoint: First day, 3 months later at the randomization time. Method of measurement: Treadmill.;New York Heart Association (NYHA) functional class. Timepoint: First day, 3 months later at the randomization time. Method of measurement: Taking History approved by physician.;Health Related Quality of Life. Timepoint: First day, 3 months later at the randomization time. Method of measurement: EmPHasis-10 Health Related Quality of life questionnaire.;Pulmonary arterial pressure (PAP). Timepoint: First day, 3 months later at the randomization time. Method of measurement: Echocardiography.;Tricuspid annular plane systolic excursion (TAPSE). Timepoint: First day, 3 months later at the randomization time. Method of measurement: Echocardiography.;Tricuspid annular plane systolic excursion (TAPSE) / Pulmonary arterial pressure (PAP). Timepoint: First day, 3 months later at the randomization time. Method of measurement: Echocardiography.;Right ventricle (RV) Size. Timepoint: First day, 3 months later at the randomization time. Method of measurement: Echocardiography.;Pericardial effusion. Timepoint: First day, 3 months later at the randomization time. Method of measurement: Echocardiography.	—

Measure

Time frame

The 6-minute walk test (6MWT) test. Timepoint: First day, 3 months later at the randomization time. Method of measurement: Treadmill.;New York Heart Association (NYHA) functional class. Timepoint: First day, 3 months later at the randomization time. Method of measurement: Taking History approved by physician.;Health Related Quality of Life. Timepoint: First day, 3 months later at the randomization time. Method of measurement: EmPHasis-10 Health Related Quality of life questionnaire.;Pulmonary arterial pressure (PAP). Timepoint: First day, 3 months later at the randomization time. Method of measurement: Echocardiography.;Tricuspid annular plane systolic excursion (TAPSE). Timepoint: First day, 3 months later at the randomization time. Method of measurement: Echocardiography.;Tricuspid annular plane systolic excursion (TAPSE) / Pulmonary arterial pressure (PAP). Timepoint: First day, 3 months later at the randomization time. Method of measurement: Echocardiography.;Right ventricle (RV) Size. Timepoint: First day, 3 months later at the randomization time. Method of measurement: Echocardiography.;Pericardial effusion. Timepoint: First day, 3 months later at the randomization time. Method of measurement: Echocardiography.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShadi Shafaghi

Shahid Beheshti University of Medical Sciences

shafaghishadi@Yahoo.Com+98 21 2712 3810

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026