CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

NCT ID: NCT06762964

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-16
• Study Completion Date: 2027-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dapagliflozin

Group Type: EXPERIMENTAL

Dapagliflozin tablet

Intervention Type: DRUG

Patient will take a 10mg tablet of Dapagliflozin once daily for 24 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type: DRUG

Patient will take 10mg placebo tablet once daily for 24 weeks

Interventions

Dapagliflozin tablet

Patient will take a 10mg tablet of Dapagliflozin once daily for 24 weeks

Intervention Type: DRUG

Placebo Tablet

Patient will take 10mg placebo tablet once daily for 24 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent prior to any study specific procedures

2. History of Fontan procedure

3. Male or female subject

4. Age ≥ 18

5. Symptoms of dyspnea (NYHA II-III) with no non-cardiac or ischemia explanation

6. Undergoing clinically indicated cardiac catheterization

7. Elevated pulmonary capillary wedge pressure (PCWP) 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.

Exclusion Criteria

1. Type I diabetes

2. 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

3. Recent hospitalization (<30 days) or revascularization (<90 days)

4. Significant valvular heart disease (≥moderate stenosis, >moderate regurgitation)

5. Significant Fontan obstruction with resting SVC-IVC gradient >4 mmHg

6. Primary cardiomyopathy (such as amyloid)

7. Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator

8. Severe anemia (hemoglobin <9 gm/dl)

9. Severe kidney disease (estimated GFR<30) or liver disease

10. 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.

11. History of serious hypersensitivity reaction to dapagliflozin

12. Subjects on dialysis

13. Subjects with severe liver disease with history of decompensation including ascites or encephalopathy or variceal bleeding

14. Single ventricle heart disease without Fontan palliation

15. Those with a history of Fontan takedown

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Luke J. Burchill

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luke Burchill, M.B.B.S., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amanda Wozniak

Role: CONTACT

Wozniak.Amanda@mayo.edu

507-266-1976

Yusef Maarouf

Role: CONTACT

Maarouf.Yusef@mayo.edu

507-422-5755

Other Identifiers

24-011044

Identifier Type: -

Identifier Source: org_study_id