CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

Phase 2RecruitingNCT06762964

Mayo Clinic27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fontan Circulation Single Ventricle Heart Disease HFpEF - Heart Failure With Preserved Ejection Fraction

Interventions

Dapagliflozin tabletDRUG

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

Placebo TabletDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (≥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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

Pulmonary capillary wedge pressure (PCWP) at rest

Pulmonary Capillary Wedge pressure will be determined by right heart catheterization with expired gas analysis. Right heart catheterization with expired gas analysis will be performed at rest. Pulmonary Capillary Wedge Pressure is measured in millimeters of mercury (mmHg).