Dapagliflozin treatment for adults with failing Fontan circulation
Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study
This study is testing if dapagliflozin, a diabetes medication, can help adults with heart failure after the Fontan procedure feel better by looking at changes in their heart pressure during rest and exercise.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06762964 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of dapagliflozin, a medication typically used for diabetes, on pulmonary capillary wedge pressure (PCWP) in adults who have undergone the Fontan procedure and are experiencing heart failure symptoms. Participants will receive either dapagliflozin or a placebo for a duration of six months. The study aims to assess changes in PCWP at rest and during exercise, providing insights into the drug's potential benefits for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of the Fontan procedure and symptoms of dyspnea due to elevated PCWP.
Not a fit: Patients with type I diabetes or those on certain excluded medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve heart function and quality of life for patients with failing Fontan circulation.
How similar studies have performed: While the use of SGLT2 inhibitors like dapagliflozin is gaining traction in heart failure management, this specific application in Fontan circulation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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-IV) with no non-cardiac or ischemia explanation 6. 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. 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Luke Burchill, M.B.B.S., Ph.D. — Mayo Clinic
- Study coordinator: Amanda Wozniak
- Email: Wozniak.Amanda@mayo.edu
- Phone: 507-266-1976
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.