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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02450-47 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| VO2 max | Functional status at baseline and 6 months assessed by VO2 max assessment | baseline and 6 months of follow-up. |
| Delta GFR estimated by CKD-EPI formula (ml/min/1.73m²) | The following parameters are collected at baseline to identify predictive factors associated with secondary endpoint. These parameters should not be considered as endpoints themselves:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillaume BAUDRY, MD | Contact | +33 (0) 383157322 | g.baudry@chru-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas GIRERD, MD-PhD | CHRU de NANCY | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospice Civil de Lyon - Hôpital Louis PRADEL | Not yet recruiting | Bron | 69500 | France |
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Prospective cohort study
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| baseline and 6 months of follow-up. |
| Rate of composite outcome (hospitalization for acute heart failure or all cause death). | The following parameters are collected at baseline to identify predictive factors associated with secondary endpoint. These parameters should not be considered as endpoints themselves:
| 6 months of follow-up. |
| Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) | Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | baseline and 12 months. |
| Global Leadership Initiative on Malnutrition criteria (GLIM Criteria) | To assess changes in nutritional status according to Global Leadership Initiative on Malnutrition criteria status between Baseline and 6 months. Categories : no malnutrition, moderate malnutrition, or severe malnutrition | baseline and 6 months |
| Daily food and nutrient intake | The food frequency questionnaire evaluate the frequency of consumption and portion size for 170 foods, we then calculate the daily food intake (in g/day). Nutritrional values are determined by converting food intake into nutrient intake using a french food composition table. Each item can have a minimum intake of 0, with quantities varying based on the specific food and individual consumption. | baseline or the month following baseline |
| cardiovascular death | To assess incidence of cardiac and renal adverse events. | 12 months |
| unplanned hospitalization for Heart failure | To assess incidence of cardiac and renal adverse events. The definition for unplanned heart failure hospitalization requires: 1) a hospital stay for worsening heart failure for >24 h; and 2) administration of intravenous or mechanical heart failure therapies, especially loop diuretics 3) heart failure symptoms/signs. | 12 months |
| worsening of Heart failure | To assess incidence of cardiac and renal adverse events. The definition for worsening of heart failure requires an administration of loop diuretics intravenous (ambulatory or home-care) due to a worsening of heart failure symptoms/signs. | 12 months |
| cardiac transplantation | To assess incidence of cardiac and renal adverse events | 12 months |
| ECMO | To assess incidence of cardiac and renal adverse events | 12 months |
| Left Ventricular Assist Device | To assess incidence of cardiac and renal adverse events | 12 months |
| Delisting from national waiting list | to assess incidence of cardiac and renal adverse events | 12 months |
| renal death | To assess incidence of cardiac and renal adverse events. | 12 months |
| chronic dialysis | To assess incidence of cardiac and renal adverse events. | 12 months |
| renal transplantation | To assess incidence of cardiac and renal adverse events. | 12 months |
| End stage renal disease | To assess incidence of cardiac and renal adverse events. Chronic dialysis, renal transplantation or sustained eGFR <15 mL/min/1.73m² | 12 months |
| worsening cardio-renal syndrome | To assess incidence of cardiac and renal adverse events. Worsening cardio-renal syndrome was defined according to the Kidney Disease Improving Global Outcomes (KIDGO) criteria as a ≥ 26.5 µmol/L (0.3mg/dL) increase in serum creatinine or 1.5-1.9 times baseline increase in serum creatinine or a urine output <0.5 ml/kg/h for 6-12 hours. | 12 months |
| GFR estimated by CKD-EPI formula (serum creatinine cystatin or both) | To assess the degree of agreement between the different methods of estimating GFR. | baseline and 6 months |
| GFR estimated by MDRD formula | To assess the degree of agreement between the different methods of estimating GFR. | baseline and 6 months |
| urinary creatinine (renal functional assessment (BFR)) | To assess the degree of agreement between the different methods of estimating GFR. | baseline and 6 months |
| iohexol clearance | to assess the degree of agreement between the different methods of estimating GFR | baseline and 6 months |
| inuline clearance | To assess the degree of agreement between the different methods of estimating GFR | baseline and 6 months |
| EDTA chrome51 | To assess the degree of agreement between the different methods of estimating GFR | baseline and 6 months |
| Iothalamate clearance | To assess the degree of agreement between the different methods of estimating GFR | baseline and 6 months |
| PLAUR gene expression | To assess the change in gene expression (including PLAUR gene) using the RNA collected at baseline and at 6 months. | baseline and 6 months |
| CHU Grenoble | Not yet recruiting | La Tronche | 38700 | France |
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| CHU Montpellier | Not yet recruiting | Montpellier | 34295 | France |
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| Chu Nantes | Not yet recruiting | Nantes | 44093 | France |
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| Aphp Hegp | Not yet recruiting | Paris | 75015 | France |
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| CHU Bordeaux | Not yet recruiting | Pessac | 33600 | France |
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| CHU Rennes | Not yet recruiting | Rennes | 35033 | France |
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| Chu Rouen | Not yet recruiting | Rouen | 76031 | France |
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| CHU Strasbourg | Not yet recruiting | Strasbourg | 67091 | France |
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| CHU de Toulouse | Not yet recruiting | Toulouse | 31059 | France |
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| Chru Nancy | Recruiting | Vandœuvre-lès-Nancy | 54500 | France |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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