NCT05717257

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 29, 2023

Last Update Submit

January 29, 2023

Conditions

Dapagliflozin Adverse ReactionEfficacySystemic Right Ventricle

Keywords

heart failuredapagliflozinsystemic right ventricle

Outcome Measures

Primary Outcomes (4)

  • Adverse Events

    Absence of any suspected or confirmed adverse events or necessity of drug discontinuation

    1 year

  • Nt-proBNP

    1 year

  • Systemic right ventricle fractional area change

    1 year

  • Systemic right ventricle global longitudinal strain

    1 year

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

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

Drug: Dapagliflozin 10mg Tab

Control

NO INTERVENTION

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

Interventions

Dapagliflozin 10mg TabDRUG

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

Dapagliflozin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adult Congenital Heart Disease, Monaldi Hospital

Naples, 80121, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to the treatment or control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 29, 2023

First Posted

February 8, 2023

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2024

Last Updated

February 8, 2023

Record last verified: 2023-01

Locations

IT(1)