A clinical trial to study the effect of Dapagliflozin in improvement of 6-minute walk distance in patients with Eisenmenger syndrome

Dapagliflozin in patients with Eisenmenger syndrome (DAPA-ES) - A single centre, double-blinded, randomized, placebo-controlled study - DAPA-ES

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096501

Enrollment

Registered

2025-10-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Health Condition 1: I278- Other specified pulmonary heart diseases

Interventions

Intervention1: Tablet Dapagliflozin: 10 mg once daily for 16 weeks Control Intervention1: Placebo tablet: 10 mg once daily for 16 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Patients with unequivocal diagnosis of Eisenmenger syndrome Systemic saturation lesser than 92 percent WHO functional class II, III

Exclusion criteria

Exclusion criteria: Receiving therapy with SGL T2 inhibitors within 4 weeks prior to randomisation or previous intolerance to SGLT2 inhibitors Type I diabetes mellitus or history of ketoacidosis Baseline eGFR lesser than 25 ml/min/l.73 m2 History of recurrent urinary tract infections (UTI) (greater than or equal to 2 infections in 6 months or greater than or equal to 3 infections in 1 year) Any other contra-indication for SGLT2 inhibitor Uncontrolled congestive cardiac failure Patients with severe L V dysfunction (LVEF lesser than 40 percent) Baseline 6MWD lesser than 165 metres Patients in WHO functional class IV Pregnancy Complex congenital CHD with increased Qp Active malignancy requiring treatment

Design outcomes

Primary

Measure	Time frame
Change in baseline measured at 16 weeks in 6-minute walk distance in patients with Eisenmenger syndromeTimepoint: Change in baseline measured at 16 weeks in 6-minute walk distance in patients with Eisenmenger syndrome	—

Secondary

Measure	Time frame
Occurrence of the following a) Serious adverse events (SAE) b) Adverse events leading to discontinuation of drug (DAE) c) Adverse events of interest - volume depletion - azotemia/ renal events - major hypoglycemic events - diabetic ketoacidosis - genito-urinary infections - electrolyte abnormalities requiring treatmentTimepoint: 8 weeks and 16 weeks;Occurrence of any of the components of this composite: • All-cause mortality • Cardiovascular death • Worsening heart failure (unplanned HF hospitalisation or urgent visit to hospital for HF) • Worsening of WHO functional class • New onset syncopeTimepoint: 8 weeks and 16 weeks;Change in baseline measured at 16 weeks in resting oxygen saturation in the two study groupsTimepoint: 16 weeks;Change in baseline measured at 16 weeks in peak oxygen consumption (V02 peak) measured by cardio-pulmonary exercise testing (CPET)Timepoint: 16 weeks;Change from baseline measured at 16 weeks in overall summary score of emPHasis-10, a patient reported outcome questionnaireTimepoint: 16 weeks;Change from baseline measured at 16 weeks in NT -pro BNPTimepoint: 16 weeks;Change from baseline measured at 16 weeks in echocardiographic parameters ofRV function (TAPSE, FAC, RVSI, RVFWLS, RVSP)Timepoint: 16 weeks	—

Measure

Time frame

Occurrence of the following a) Serious adverse events (SAE) b) Adverse events leading to discontinuation of drug (DAE) c) Adverse events of interest - volume depletion - azotemia/ renal events - major hypoglycemic events - diabetic ketoacidosis - genito-urinary infections - electrolyte abnormalities requiring treatmentTimepoint: 8 weeks and 16 weeks;Occurrence of any of the components of this composite: • All-cause mortality • Cardiovascular death • Worsening heart failure (unplanned HF hospitalisation or urgent visit to hospital for HF) • Worsening of WHO functional class • New onset syncopeTimepoint: 8 weeks and 16 weeks;Change in baseline measured at 16 weeks in resting oxygen saturation in the two study groupsTimepoint: 16 weeks;Change in baseline measured at 16 weeks in peak oxygen consumption (V02 peak) measured by cardio-pulmonary exercise testing (CPET)Timepoint: 16 weeks;Change from baseline measured at 16 weeks in overall summary score of emPHasis-10, a patient reported outcome questionnaireTimepoint: 16 weeks;Change from baseline measured at 16 weeks in NT -pro BNPTimepoint: 16 weeks;Change from baseline measured at 16 weeks in echocardiographic parameters ofRV function (TAPSE, FAC, RVSI, RVFWLS, RVSP)Timepoint: 16 weeks

—

Countries

India

Contacts

Public ContactDr Prithivi Raaj P

All India Institute of Medical Sciences, New Delhi

drsatyaviryadav87@gmail.com8953921091

Outcome results

None listed

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