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New treatment option for Heart Failure
Official title Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List
ClinicalTrials.gov ID: NCT06868797
What this study is testing
- What it's testing
- Heart failure affects 1 to 2% of the adult population in developed countries, representing about 55 million people worldwide. Advanced heart failure is a condition where the heart can no longer provide sufficient cardiac output or equilibrate pressures within its chambers, leading to symptoms such as shortness of breath, fatigue, and water and salt retention.
- Time commitment: about 12 months
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
- Age ≥ 18 years and ≤ 85 years
- NYHA class ≥3
- LVEF ≤ 35%
- On GDMT (including dapagliflozin) based on current heart failure practice guidelines at maximal tolerated dose
- On waiting list (or on the registration pathway) for heart transplantation after multidisciplinary Heart Team decision, with anticipated access to...
You likely can't join if
- Priority patient on waiting list for heart transplantation.
- Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or...
- Inotrope dependent, existence of ongoing mechanical circulatory support
- Current acute decompensated HF or hospitalization due to decompensated HF \<30 days prior to the enrolment.
- History of any organ transplant or prior implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after...
- Any recent treatment procedure likely to improve symptoms and heart failure status (coronary revascularization, percutaneous mitral valve...
See the full eligibility criteria
- Age ≥ 18 years and ≤ 85 years
- NYHA class ≥3
- LVEF ≤ 35%
- On GDMT (including dapagliflozin) based on current heart failure practice guidelines at maximal tolerated dose
- On waiting list (or on the registration pathway) for heart transplantation after multidisciplinary Heart Team decision, with anticipated access to heart transplant ≥ 6 months or in a pre-transplant pathway.
- Person affiliated to a social security scheme or beneficiary of such a scheme.
- A person who has received full information about the organization of the clinical research and has signed an informed consent form.
- Priority patient on waiting list for heart transplantation.
- Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy.
- Inotrope dependent, existence of ongoing mechanical circulatory support
- Current acute decompensated HF or hospitalization due to decompensated HF \<30 days prior to the enrolment.
- History of any organ transplant or prior implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after inclusion.
- Any recent treatment procedure likely to improve symptoms and heart failure status (coronary revascularization, percutaneous mitral valve intervention, cardiac resynchronization therapy) \< 60 days.
- Glomerular filtration rate \<25 ml/min/1.73 m2, according to CKD-EPI formula
- Unstable or rapidly progressing renal disease (autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis).
- Type 1 diabetes mellitus.
- Participation in another clinical treatment trial.
- Any condition other than heart failure that could limit survival to less than 12 months.
- Pregnant women or breastfeeding mothers
- vulnerable persons (guardianship, curatorship, safeguard of justice)
The study team makes the final eligibility decision.
Where it's taking place
- Bron, France
- La Tronche, France
- Montpellier, France
- Nantes, France
- Paris, France
- Pessac, France
- Rennes, France
- Rouen, France
- Strasbourg, France
- Toulouse, France
- Vandœuvre-lès-Nancy, France
Compensation & support
A stipend or compensation may be offered.
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Bron, France; La Tronche, France; Montpellier, France; Nantes, France; Paris, France; Pessac, France and 5 more location(s). 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.