Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE)

Sponsor

Monaldi Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05717257

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dapagliflozin Adverse Reaction Efficacy Systemic Right Ventricle	Drug: Dapagliflozin 10mg Tab	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomly assigned to the treatment or control groupParticipants will be randomly assigned to the treatment or control group

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of Dapagliflozin in Adult Patients With a Systemic Right Ventricle

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dapagliflozin Dapagliflozin will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction	Drug: Dapagliflozin 10mg Tab Dapagliflozin 10 mg will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction
No Intervention: Control Participants assigned to this group will continue the standard optimized medical therapy

Arm

Intervention/Treatment

Experimental: Dapagliflozin

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

Drug: Dapagliflozin 10mg Tab

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

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

Adverse Events [1 year]
Absence of any suspected or confirmed adverse events or necessity of drug discontinuation
Nt-proBNP [1 year]
Systemic right ventricle fractional area change [1 year]
Systemic right ventricle global longitudinal strain [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adult Congenital Heart Disease, Monaldi Hospital	Naples		Italy	80121

Sponsors and Collaborators

Monaldi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Flavia Fusco, Medical Doctor, Monaldi Hospital

ClinicalTrials.gov Identifier:

NCT05717257

Other Study ID Numbers:

First Posted:

Feb 8, 2023

Last Update Posted:

Feb 8, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Flavia Fusco, Medical Doctor, Monaldi Hospital

heart failure

dapagliflozin

systemic right ventricle

Additional relevant MeSH terms:

Dapagliflozin

Study Results

No Results Posted as of Feb 8, 2023