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CAMEO-FONTAN: Dapagliflozin for Failing Fontan Circulation

This study is looking at whether a medicine called dapagliflozin can help adults who have a "failing Fontan circulation." This is a condition that can happen after a specific heart surgery (Fontan procedure) for single ventricle heart disease, and it can lead to heart failure with preserved ejection fraction (HFpEF). You might be able to join if you are 18 or older, have had a Fontan procedure, and experience shortness of breath (dyspnea) with elevated peripheral venous pressure (PVP). The study will measure your PVP at rest and during exercise to see if dapagliflozin improves it over 12 weeks. The current status of this study is unclear, and it plans to enroll 27 participants.

Study design
This is an interventional study where participants will receive either dapagliflozin or a placebo. It plans to enroll 27 participants.
What's involved
You would take a 10mg tablet of either dapagliflozin or a placebo once daily for 12 weeks. Peripheral venous pressure will be measured at the start and after 12 weeks, at rest, with feet elevated, and during exercise.
Compensation
Not stated in the trial record.
Follow-up
Peripheral venous pressure will be measured at the start of the study and after 12 weeks of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06762964

CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~27 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Dapagliflozin tabletPlacebo Tablet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peripheral venous pressure (PVP) at rest
Measured over Baseline, 12 Weeks
+2 more outcomes measured

Conditions

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

Explore related trials

Fontan CirculationHeart FailureSingle Ventricle Heart Disease

NCT06762964

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic

    Rochester, Minnesotano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Luke Burchill, M.B.B.S., Ph.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Amanda Wozniak
[email protected]
507-266-1976
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Peripheral venous pressure (PVP) at restBaseline, 12 Weeks

    Peripheral venous pressure (PVP) at rest will be determined by Stress Echocardiogram. Peripheral venous pressure (PVP) is measured in millimeters of mercury (mmHg).

  • Peripheral venous pressure (PVP) with feet elevatedBaseline, 12 Weeks

    Peripheral venous pressure (PVP) with feet elevated will be determined by Stress Echocardiogram. Peripheral venous pressure (PVP) is measured in millimeters of mercury (mmHg).

  • Peripheral venous pressure (PVP) at 20W exerciseBaseline, 12 Weeks

    Peripheral venous pressure (PVP) at 20W exercise will be determined by Stress Echocardiogram. Peripheral venous pressure (PVP) is measured in millimeters of mercury (mmHg).