Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE)

Sponsor
Monaldi Hospital
Study ID
NCT05717257
Phase
PHASE4
Status
Unknown

Conditions

  • Dapagliflozin Adverse Reaction
  • Efficacy
  • Systemic Right Ventricle

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 1, 2022
Status verified
Jan 2023
Primary completion
Aug 31, 2023
Completion
Aug 31, 2024

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin 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

Primary Outcome Measure

Adverse Events [ Time Frame: 1 year ]

Related Studies