Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 103
- 试验地点
- 22
- 主要终点
- the change in soluble urokinase-type plasminogen activator receptor (suPAR) levels (ng/ml)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 85 years
- •NYHA class ≥3
- •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.
排除标准
- •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.
- •History of any organ transplant or prior implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after inclusion.
- •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)
结局指标
主要结局
the change in soluble urokinase-type plasminogen activator receptor (suPAR) levels (ng/ml)
时间窗: 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.
次要结局
- VO2 max(baseline and 6 months of follow-up.)
- End stage renal disease(12 months)
- chronic dialysis(12 months)
- renal transplantation(12 months)
- Left Ventricular Assist Device(12 months)
- Delisting from national waiting list(12 months)
- renal death(12 months)
- 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.)
- Daily food and nutrient intake(baseline or the month following baseline)
- cardiovascular death(12 months)
- unplanned hospitalization for Heart failure(12 months)
- worsening of Heart failure(12 months)
- cardiac transplantation(12 months)
- ECMO(12 months)
- 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)
- Daily food and nutrient intake(baseline or the month following baseline)
- cardiovascular death(12 months)
- unplanned hospitalization for Heart failure(12 months)
- worsening of Heart failure(12 months)
- cardiac transplantation(12 months)
- ECMO(12 months)
- Left Ventricular Assist Device(12 months)
- Delisting from national waiting list(12 months)
- renal death(12 months)
- chronic dialysis(12 months)
- renal transplantation(12 months)
- End stage renal disease(12 months)
- worsening cardio-renal syndrome(12 months)
- GFR estimated by CKD-EPI formula (serum creatinine cystatin or both)(baseline and 6 months)
- GFR estimated by MDRD formula(baseline and 6 months)
- urinary creatinine (renal functional assessment (BFR))(baseline and 6 months)
- iohexol clearance(baseline and 6 months)
- inuline clearance(baseline and 6 months)
- EDTA chrome51(baseline and 6 months)
- Iothalamate clearance(baseline and 6 months)
- PLAUR gene expression(baseline and 6 months)
研究者
BAUDRY Guillaume
coordinating investigator
Central Hospital, Nancy, France