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Recruiting NCT06762964

CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dapagliflozin tablet, Placebo Tablet.
Who it may be relevant to
Registry conditions: Fontan Circulation, Single Ventricle Heart Disease, HFpEF - Heart Failure With Preserved Ejection Fraction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Dapagliflozin tablet
    Patient will take a 10mg tablet of Dapagliflozin once daily for 12 weeks
  • Drug Placebo Tablet
    Patient will take 10mg placebo tablet once daily for 12 weeks

Primary outcome measures

  • Peripheral venous pressure (PVP) at rest [Time frame: Baseline, 12 Weeks]
  • Peripheral venous pressure (PVP) with feet elevated [Time frame: Baseline, 12 Weeks]
  • Peripheral venous pressure (PVP) at 20W exercise [Time frame: Baseline, 12 Weeks]
Secondary outcome measures (8)
  • Cardiac output at rest [Time frame: Baseline, 12 Weeks]
  • Cardiac output with exercise [Time frame: Baseline, 12 Weeks]
  • Peak oxygen consumption (VO2) during exercise [Time frame: Baseline, 12 Weeks]
  • Change in plasma volume [Time frame: Baseline, 12 Weeks]
  • Change in blood volume [Time frame: Baseline, 12 Weeks]
  • SF-36 quality of life (QOL) [Time frame: Baseline, 12 Weeks]
  • Change in fat mass [Time frame: Baseline, 12 Weeks]
  • Change in fat free mass [Time frame: Baseline, 12 Weeks]

Eligibility criteria

Inclusion criteria

  • Signed informed consent prior to any study specific procedures
  • History of Fontan procedure
  • Male or female subject
  • Age ≥ 18
  • Symptoms of dyspnea (NYHA II-IV) with no non-cardiac or ischemia explanation
  • 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

  • Type I diabetes
  • 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
  • Recent hospitalization (<30 days) or revascularization (<90 days)
  • Significant valvular heart disease (≥moderate stenosis, >moderate regurgitation)
  • Significant Fontan obstruction with resting SVC-IVC gradient >4 mmHg
  • Primary cardiomyopathy (such as amyloid)
  • Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator
  • Severe anemia (hemoglobin <9 gm/dl)
  • Severe kidney disease (estimated GFR<30) or liver disease
  • 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.
  • History of serious hypersensitivity reaction to dapagliflozin
  • Subjects on dialysis
  • Subjects with severe liver disease with history of decompensation including ascites or encephalopathy or variceal bleeding
  • Single ventricle heart disease without Fontan palliation
  • Those with a history of Fontan takedown

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT06762964 · 24-011044

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗