Interventional Recruiting
NCT06868797 on ClinicalTrials.gov
Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List
- Sponsor: Centre Hospitalier Universitaire de Nancy
- Enrollment: 103 (Estimated)
- Study start: 2025-08-29 (Actual)
- Primary completion: 2027-02-28 (Estimated)
- Study completion: 2027-09-12 (Estimated)
- Allocation: N/a
- InterventionModel: Single Group
- InterventionModelDescription: Prospective cohort study
- Masking: None
- PrimaryPurpose: Other
Brief Summary
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.
Heart failure affects the kidneys by reducing blood flow directed to them, sometimes leading to kidney congestion. In the long term, this can degrade kidney function. Common medications used to treat heart failure, such as diuretics, can sometimes worsen kidney failure. This link between the heart and the kidneys is known as cardio-renal syndrome and requires careful management of both organs to prevent mutual degradation.
Dapagliflozin is an SGLT2 inhibitor medication used to treat type 2 diabetes, heart failure, and certain kidney diseases. It helps reduce blood sugar, improve heart and kidney function, while promoting the elimination of excess salt and water.
However, there are limited data regarding the progression of cardio-renal interactions in patients with advanced heart failure. Yet, advanced heart failure is often associated with kidney dysfunction.
The protein called suPAR is found in the blood of patients developing kidney disease and/or during the onset of acute kidney injury. This protein will allow to characterize a population of patients with advanced heart failure receiving optimized medical treatment, including dapagliflozin.
The main objective of this research is to assess, based on the suPAR protein level in the blood, the progression of cardio-renal damage between inclusion and 6 months in patients with advanced heart failure who are listed for a heart transplant and treated with a therapy including dapagliflozin.
The study plans 5 visits over 12 months. The research will take place in the cardiology department of several French hospitals.
Conditions
- Heart Failure
Intervention / Treatment
- Other: Biological sample for the measurement of suPAR levels.
Primary Outcome Measures
-
the change in soluble urokinase-type plasminogen activator receptor (suPAR) levels (ng/ml)
(baseline and 6 months of follow-up.)
the change in soluble urokinase-type plasminogen activator receptor (suPAR) levels (ng/ml) between the baseline and 6 months of follow-up.
Countries
France
Locations and Investigators
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Hospice Civil de Lyon - Hôpital Louis PRADEL, Bron, France (Not yet recruiting)
- Nathan MEWTON, MD-PhD
- Nathan MEWTON, MD-PhD (Principal Investigator)
-
CHU Grenoble, La Tronche, France (Not yet recruiting)
- Aude BOIGNARD, MD
- Aude Boignard, MD (Principal Investigator)
-
CHU Montpellier, Montpellier, France (Not yet recruiting)
- Valentin DUPASQUIER, MD-PhD
- VALENTIN DUPASQUIER, MD-PhD (Principal Investigator)
-
Chu Nantes, Nantes, France (Not yet recruiting)
- Sabine PATTIER, MD-PhD
- Sabine PATTIER, MD-PhD (Principal Investigator)
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Aphp Hegp, Paris, France (Not yet recruiting)
- Anne Céline MARTIN, MD-PhD
- Anne Céline MARTIN, MD-PhD (Principal Investigator)
-
CHU Bordeaux, Pessac, France (Not yet recruiting)
- Maxime FAURE, MD-PhD
- Maxime FAURE, MD-PhD (Principal Investigator)
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CHU Rennes, Rennes, France (Not yet recruiting)
- Céline CHABANNES, MD-PhD
- Céline CHABANNES, MD-PhD (Principal Investigator)
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Chu Rouen, Rouen, France (Not yet recruiting)
- Charles FAUVEL, MD-PhD
- Charles FAUVEL, MD-PhD (Principal Investigator)
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CHU Strasbourg, Strasbourg, France (Not yet recruiting)
- Jean Jacques VON HUNOLSTEIN, MD-PhD
- Jean Jacques VON HUNOLSTEIN, MD-PhD (Principal Investigator)
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CHU de Toulouse, Toulouse, France (Not yet recruiting)
- Romain ITIER, MD-PhD
- Romain ITIER, MD-PhD (Principal Investigator)
-
Chru Nancy, Vandœuvre-lès-Nancy, France (Recruiting)
- Guillaume BAUDRY, MD
- Guillaume BAUDRY, MD (Principal Investigator)
Study Officials
- Nicolas GIRERD, MD-PhD (Study Chair) — CHRU de NANCY