A Study of Dapagliflozin in the Failing Fontan Circulation

Overview

About this study

The purpose of this study is to determine whether treatment with DAPA for 6 months will improve pulmonary capillary wedge pressure (PCWP) at rest and during exercise in adults with a Fontan circulation and improve cardiac metabolism.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

Subjects are eligible to be randomized in the study only if all the following inclusion criteria and none of the exclusion criteria apply:

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 (≥25 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/17/2025. Questions regarding updates should be directed to the study team contact.
 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

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

Contact us for the latest status

Contact information:

Amanda Wozniak

(507) 266-1976

Wozniak.Amanda@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20577060

Mayo Clinic Footer