Dapagliflozin treatment for adults with failing Fontan circulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.