Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE) (DAPA-SERVE)

January 29, 2023 updated by: Flavia Fusco, Monaldi Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 1 year
Absence of any suspected or confirmed adverse events or necessity of drug discontinuation
1 year
Nt-proBNP
Time Frame: 1 year
1 year
Systemic right ventricle fractional area change
Time Frame: 1 year
1 year
Systemic right ventricle global longitudinal strain
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monaldi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2022

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

August 1, 2024

Study Registration Dates

First Submitted

January 29, 2023

First Submitted That Met QC Criteria

January 29, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

January 29, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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