Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Anita Saraf
Study ID
NCT06260059
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Empagliflozin 10 MG — DRUG
    Patient will be given 10 mg of Empagliflozin if randomized to the drug arm or will receive placebo drug for 1 year
  • Placebo — DRUG
    To patients randomized to the placebo group, a placebo pill will be given

Study Details

The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD).

Key Dates

Start date
Sep 17, 2024
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Jun 1, 2027

Study Design

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

Arms

  • Experimental: Empagliflozin 10 MG
    Empagliflozin 10 mg daily will be administered for 1 year. The patient and the PI will be blinded (unaware) of the group they are assigned to.
  • Placebo Comparator: Placebo
    Placebo for 1 year

Primary Outcome Measure

Change in Ejection fraction (EF) [ Time Frame: Change from baseline in ejection fraction at 1-year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Children's Hospital of PittsburghPittsburghPennsylvania15224
Anita Saraf, MD,PhD
[email protected]
Magee Women's HospitalPittsburghPennsylvania15213
Anita Saraf, MD, PhD
[email protected]
Presbyterian HospitalPittsburghPennsylvania15213
Anita Saraf, MD, PhD
[email protected]

Find similar trials in Pittsburgh, PA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Children's Hospital of Pittsburgh· Pittsburgh, PAMagee Women's Hospital· Pittsburgh, PAPresbyterian Hospital· Pittsburgh, PA

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