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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hospice Civil de Lyon - Hôpital Louis PRADEL
NOT_YET_RECRUITING
Bron
CHU Grenoble
NOT_YET_RECRUITING
La Tronche
CHU Montpellier
NOT_YET_RECRUITING
Montpellier
Chu Nantes
NOT_YET_RECRUITING
Nantes
Aphp Hegp
NOT_YET_RECRUITING
Paris
CHU Bordeaux
NOT_YET_RECRUITING
Pessac
CHU Rennes
NOT_YET_RECRUITING
Rennes
Chu Rouen
NOT_YET_RECRUITING
Rouen
CHU Strasbourg
NOT_YET_RECRUITING
Strasbourg
CHU de Toulouse
NOT_YET_RECRUITING
Toulouse
Chru Nancy
RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Guillaume BAUDRY, MD
g.baudry@chru-nancy.fr
+33 (0) 383157322
Time Frame
Start Date: 2025-08-29
Estimated Completion Date: 2027-09-12
Participants
Target number of participants: 103
Treatments
Other: Patients followed for end-stage heart failure
Patients followed for end-stage heart failure and waiting for heart transplantation. This cohort will focus on cardio-renal assessment of advanced HF patients treated with optimal pharmacologic therapy including dapagliflozin. The biological material and clinical data collected will allow us to better understand the advanced HF and to generate new research hypotheses.
Sponsors
Leads: Central Hospital, Nancy, France

This content was sourced from clinicaltrials.gov