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RecruitingPhase 2

CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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-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

Study sites (1)

MN