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

NCT06868797 | Recruiting

• 2 other identifiers: 2023PI0242024-A02450-47
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 11

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

Outcome Measures

Primary Outcomes (1)

• the change in soluble urokinase-type plasminogen activator receptor (suPAR) levels (ng/ml)

  the change in soluble urokinase-type plasminogen activator receptor (suPAR) levels (ng/ml) between the baseline and 6 months of follow-up.

  baseline and 6 months of follow-up.

Secondary Outcomes (26)

• VO2 max

  baseline and 6 months of follow-up.

• Delta GFR estimated by CKD-EPI formula (ml/min/1.73m²)

  baseline and 6 months of follow-up.

• Rate of composite outcome (hospitalization for acute heart failure or all cause death).

  6 months of follow-up.

• Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

  baseline and 12 months.

• Global Leadership Initiative on Malnutrition criteria (GLIM Criteria)

  baseline and 6 months

Study Arms (1)

Patients followed for end-stage heart failure

OTHER

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.

Other: Biological sample for the measurement of suPAR levels.

Interventions

Biological sample for the measurement of suPAR levels. OTHER

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.

Patients followed for end-stage heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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 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.
• Any recent interventional 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 interventional 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)

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (11)

Hospice Civil de Lyon - Hôpital Louis PRADEL

Bron, 69500, France

NOT YET RECRUITING

CHU Grenoble

La Tronche, 38700, France

NOT YET RECRUITING

CHU Montpellier

Montpellier, 34295, France

NOT YET RECRUITING

Chu Nantes

Nantes, 44093, France

NOT YET RECRUITING

Aphp Hegp

Paris, 75015, France

NOT YET RECRUITING

CHU Bordeaux

Pessac, 33600, France

NOT YET RECRUITING

CHU Rennes

Rennes, 35033, France

NOT YET RECRUITING

Chu Rouen

Rouen, 76031, France

NOT YET RECRUITING

CHU Strasbourg

Strasbourg, 67091, France

NOT YET RECRUITING

CHU de Toulouse

Toulouse, 31059, France

NOT YET RECRUITING

Chru Nancy

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Nicolas GIRERD, MD-PhD

  CHRU de NANCY

  STUDY CHAIR

Central Study Contacts

Guillaume BAUDRY, MD

CONTACT

+33 (0) 383157322; g.baudry@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: coordinating investigator

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 11, 2025
• Study Start: August 29, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): September 12, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

FR (11)