BridgeMD
New treatment option for Fontan Circulation
Official title CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation
ClinicalTrials.gov ID: NCT06762964
What this study is testing
What is Dapagliflozin tablet?
Dapagliflozin tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for fontan circulation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Type I diabetes
- Any of the following medications: Insulin or Pramlintide, Sandostatin, Akeega (abiraterone acetate), Growth Hormone (Somatogrogon-GHLA), Lithium...
- 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)
See the full eligibility 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...
- 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)...
- 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
- people on dialysis
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.