Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Signed informed consent prior to any study specific procedures
• History of Fontan procedure
• Male or female subject
• Age ≥ 18
• Symptoms of dyspnea (NYHA II-IV) with no non-cardiac or ischemia explanation
• Elevated peripheral venous pressure (PVP) at rest or during exercise (≥20 mmHg) ascertained at Visit 1. Patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized.
Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
Contact Information
Primary
Amanda Wozniak
Wozniak.Amanda@mayo.edu
507-266-1976
Backup
Yusef Maarouf
Maarouf.Yusef@mayo.edu
507-422-5755
Time Frame
Start Date: 2025-05-16
Estimated Completion Date: 2027-02
Participants
Target number of participants: 27
Treatments
Experimental: Dapagliflozin
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic