Trials / Recruiting
RecruitingNCT06762964
CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation
Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 6 months affects pulmonary capillary wedge pressure (PCWP) at rest and during exercise in adults with failing Fontan circulation.
Conditions
- Fontan Circulation
- Single Ventricle Heart Disease
- HFpEF - Heart Failure With Preserved Ejection Fraction
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dapagliflozin tablet | Patient will take a 10mg tablet of Dapagliflozin once daily for 24 weeks |
| DRUG | Placebo Tablet | Patient will take 10mg placebo tablet once daily for 24 weeks |
Timeline
- Start date
- 2025-05-16
- Primary completion
- 2027-02-01
- Completion
- 2027-02-01
- First posted
- 2025-01-08
- Last updated
- 2025-10-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06762964. Inclusion in this directory is not an endorsement.