CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06762964
Phase
PHASE2
Status
Recruiting
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Conditions

  • Fontan Circulation
  • HFpEF - Heart Failure With Preserved Ejection Fraction
  • Single Ventricle Heart Disease

Eligibility Criteria

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

Interventions

  • Dapagliflozin tablet — DRUG
    Patient will take a 10mg tablet of Dapagliflozin once daily for 12 weeks
  • Placebo Tablet — DRUG
    Patient will take 10mg placebo tablet once daily for 12 weeks

Study Details

The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 3 months affects peripheral venous pressure at rest and during exercise in adults with failing Fontan circulation.

Key Dates

Start date
May 16, 2025
Status verified
May 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

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

Arms

  • Experimental: Dapagliflozin
  • Placebo Comparator: Placebo

Primary Outcome Measure

Peripheral venous pressure (PVP) at rest [ Time Frame: Baseline, 12 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Luke Burchill, M.B.B.S., Ph.D. (PRINCIPAL_INVESTIGATOR)

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