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RECRUITING
NCT06868797
NA

Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List

Sponsor: Central Hospital, Nancy, France

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

103

Start Date

2025-08-29

Completion Date

2027-09-12

Last Updated

2025-09-11

Healthy Volunteers

No

Conditions

Interventions

OTHER

Biological sample for the measurement of suPAR levels.

Biological sample for the measurement of plasminogen activator receptor (suPAR) level at baseline and at 6 months follow up to assess the evolution of cardio-renal interaction in HF patients listed for heart transplant treated by GDMT including dapagliflozin.

Locations (11)

Hospice Civil de Lyon - Hôpital Louis PRADEL

Bron, France

CHU Grenoble

La Tronche, France

CHU Montpellier

Montpellier, France

Chu Nantes

Nantes, France

Aphp Hegp

Paris, France

CHU Bordeaux

Pessac, France

CHU Rennes

Rennes, France

Chu Rouen

Rouen, France

CHU Strasbourg

Strasbourg, France

CHU de Toulouse

Toulouse, France

Chru Nancy

Vandœuvre-lès-Nancy, France