Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE)

NCT ID: NCT05717257

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-08-31

Brief Summary

The purpose of this study is to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle.

Detailed Description

This is a prospective double arm study aiming to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle.

Dapagliflozin will be prescribed in a group of randomly selected patients in addition to the optimized medical therapy for heart failure with reduced ejection fraction.

Changes in quality of life indicators, symptoms, biohumoral markers, exercise capacity and echocardiographic parameters of systolic right ventricular function will be evaluated in comparison with the control group, which will continue standard heart failure therapy.

Conditions

Dapagliflozin Adverse Reaction; Efficacy; Systemic Right Ventricle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dapagliflozin

Dapagliflozin will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction

Group Type: EXPERIMENTAL

Dapagliflozin 10mg Tab

Intervention Type: DRUG

Dapagliflozin 10 mg will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction

Control

Participants assigned to this group will continue the standard optimized medical therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dapagliflozin 10mg Tab

Dapagliflozin 10 mg will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age≥18years
• Optimal medical therapy or at least 3months
• Systemic right ventricle ejection fraction≤40%, assessed on echocardiography

Exclusion Criteria

• Univentricular physiology
• Systolic blood pressure<90mmHg
• Glomerular filtration rate(GFR)<30ml/min

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Monaldi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Flavia Fusco

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Adult Congenital Heart Disease, Monaldi Hospital

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Flavia Fusco, MD

Role: primary

flavia.fusco@ospedalideicolli.it

00390817064206

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id