Fontan CirculationPhase 2NCT06762964
CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation
A Phase 2 study testing Dapagliflozin tablet in people with Fontan Circulation and Single Ventricle Heart Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fontan Circulation, Single Ventricle Heart Disease, HFpEF - Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Dapagliflozin tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2025to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Type I diabetes
- Any of the following medications: Insulin or Pramlintide, Sandostatin, Akeega (abiraterone acetate), Growth Hormone (Somatogrogon-GHLA), Lithium, Chloroquine, Hydroxychloroquine, Thioctic acid (alpha lipoic acid), Empagliflozin or Canagliflozin
- Recent hospitalization (<30 days) or revascularization (<90 days)
- Significant valvular heart disease (≥moderate stenosis, >moderate regurgitation)
- Significant Fontan obstruction with resting SVC-IVC gradient >4 mmHg
- Primary cardiomyopathy (such as amyloid)
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- Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator
- Severe anemia (hemoglobin <9 gm/dl)
- Severe kidney disease (estimated GFR<30) or liver disease
- Women of childbearing potential not willing to use a medically accepted method of contraception OR who are currently pregnant (confirmed with positive pregnancy test) or breast feeding.
- History of serious hypersensitivity reaction to dapagliflozin
- Subjects on dialysis
- Subjects with severe liver disease with history of decompensation including ascites or encephalopathy or variceal bleeding
- Single ventricle heart disease without Fontan palliation
- Those with a history of Fontan takedown
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Luke Burchill, M.B.B.S., Ph.D.
About this study
Official title: Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study
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.
- Conditions
- Fontan Circulation, Single Ventricle Heart Disease, HFpEF - Heart Failure With Preserved Ejection Fraction
- Being tested
- Dapagliflozin tablet, Placebo Tablet
- Keywords
- Fontan, HFpEF, SGLT2 inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin tabletDrug
Patient will take a 10mg tablet of Dapagliflozin once daily for 12 weeks
Placebo TabletDrug
Patient will take 10mg placebo tablet once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Not described Receives: Drug: Dapagliflozin tablet |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral venous pressure (PVP) at rest
Peripheral venous pressure (PVP) at rest will be determined by Stress Echocardiogram. Peripheral venous pressure (PVP) is measured in millimeters of mercury (mmHg).
Measured: Baseline, 12 Weeks
Peripheral venous pressure (PVP) with feet elevated
Peripheral venous pressure (PVP) with feet elevated will be determined by Stress Echocardiogram. Peripheral venous pressure (PVP) is measured in millimeters of mercury (mmHg).
Measured: Baseline, 12 Weeks
Peripheral venous pressure (PVP) at 20W exercise
Peripheral venous pressure (PVP) at 20W exercise will be determined by Stress Echocardiogram. Peripheral venous pressure (PVP) is measured in millimeters of mercury (mmHg).
Measured: Baseline, 12 Weeks
Secondary outcomes (8)
Cardiac output at rest
Cardiac output measures the amount of blood the heart pumps per minute. It is calculated by Cardiac Output= Oxygen Consumption/(Arterial - Venous Oxygen Content Difference). Cardiac output will be measured in liters per minute (L/min).
Measured: Baseline, 12 Weeks
Cardiac output with exercise
Cardiac output measures the amount of blood the heart pumps per minute. It is calculated by Cardiac Output= Oxygen Consumption/(Arterial - Venous Oxygen Content Difference). Cardiac output will be measured in liters per minute (L/min).
Measured: Baseline, 12 Weeks
Peak oxygen consumption (VO2) during exercise
Peak oxygen consumption (VO2) is measured in milliliters of oxygen per minute (mL/min).
Measured: Baseline, 12 Weeks
Change in plasma volume
Plasma volume will be determined by radiolabeled iodinated albumin (131I, 5-25 μCu) indicator dilution technique (BVA-100 Blood Volume Analyzer, Daxor Corp, NY). Plasma volume will be measured in milliliters (mL).
Measured: Baseline, 12 Weeks
Change in blood volume
Blood volume will be determined by radiolabeled iodinated albumin (131I, 5-25 μCu) indicator dilution technique (BVA-100 Blood Volume Analyzer, Daxor Corp, NY). Blood volume will be measured in milliliters (mL).
Measured: Baseline, 12 Weeks
SF-36 quality of life (QOL)
SF-36 quality of life (QOL) questionnaire is a 36-question questionnaire that evaluates a patient's quality of life. The score range is from 0-100, with a higher score reflecting a better quality of life.
Measured: Baseline, 12 Weeks
Change in fat mass
Fat mass will be determined by Dual Energy X-ray Absorptiometry Scan. Fat mass will be measured in kilograms (kg).
Measured: Baseline, 12 Weeks
Change in fat free mass
Fat free mass will be determined by Dual Energy X-ray Absorptiometry Scan. Fat free mass will be measured in kilograms (kg).
Measured: Baseline, 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start16 May 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fontan CirculationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luke J. Burchill, Mayo Clinic
- Investigators
- Luke Burchill, M.B.B.S., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762964
- Sponsor's protocol ID
- 24-011044
- Status last verified
- May 2026
- First submitted
- 2 Jan 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study
- ClinicalTrials.gov ID
- NCT06762964
- Acronym / sponsor ID
- 24-011044
- Conditions
- Fontan Circulation, Single Ventricle Heart Disease, HFpEF - Heart Failure With Preserved Ejection Fraction
- Keywords
- Fontan, HFpEF, SGLT2 inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin tablet |
| Placebo | Placebo comparator | Drug: Placebo Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- Type I diabetes
- Any of the following medications: Insulin or Pramlintide, Sandostatin, Akeega (abiraterone acetate), Growth Hormone (Somatogrogon-GHLA), Lithium, Chloroquine, Hydroxychloroquine, Thioctic acid (alpha lipoic acid), Empagliflozin or Canagliflozin
- Recent hospitalization (<30 days) or revascularization (<90 days)
- Significant valvular heart disease (≥moderate stenosis, >moderate regurgitation)
- Significant Fontan obstruction with resting SVC-IVC gradient >4 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin tabletPatient will take a 10mg tablet of Dapagliflozin once daily for 12 weeks | Drug | Dapagliflozin |
| Placebo TabletPatient will take 10mg placebo tablet once daily for 12 weeks | Drug | Placebo |
Primary outcome
Peripheral venous pressure (PVP) at rest
Time frame: Baseline, 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 elevated
Time frame: Baseline, 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 exercise
Time frame: Baseline, 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).
8 secondary outcomes
Cardiac output at rest
Time frame: Baseline, 12 Weeks
Cardiac output with exercise
Time frame: Baseline, 12 Weeks
Peak oxygen consumption (VO2) during exercise
Time frame: Baseline, 12 Weeks
Change in plasma volume
Time frame: Baseline, 12 Weeks
Change in blood volume
Time frame: Baseline, 12 Weeks
SF-36 quality of life (QOL)
Time frame: Baseline, 12 Weeks
Change in fat mass
Time frame: Baseline, 12 Weeks
Change in fat free mass
Time frame: Baseline, 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luke Burchill, M.B.B.S., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin tablet in people with Fontan Circulation and Single Ventricle Heart Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Wozniak (507-266-1976, Wozniak.Amanda@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral venous pressure (PVP) at rest (time frame: Baseline, 12 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.