Lyon and Rhône Alpes Auvergne Registry of Congestive Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from Baseline Quality of life questionnaire : EuroQol (EQ-5D) at 12 months
研究概览
简要总结
This is a prospective cohort study of patients with Heart Failure with an eighteen-month follow-up aimed to collect all demographic, clinical, biological and para-clinical data to study population characteristics, assess prognosis markers and occurrence of HF treatment side effects.
Congestive Heart failure is a frequent pathology and its prevalence increases with age. Its prognosis stays pejorative despite years of major therapeutical progress. In recent trials, all-cause mortality rates at 1-year reach up to 20% and 50% at 5 years.
Medical care of congestive heart failure is based on precise international recommendations. The association of Beta-Blockers, renin-angiotensin system blockers, mineralocorticoid receptor antagonists, represent the basis of the pharmacological treatment.
Cardiac resynchronization treatment and implantable cardioverter-defibrillator are additional efficient treatments that reduce events in appropriately selected patients.
Despite these improvements, the prognostic of congestive heart failure in registers is worse than those observed in randomized trials. This can be explained by differences in congestive heart failure patient populations and/or by a less rigorous medical care where treatments are not optimized.
The evaluation of medical care in congestive heart failure is today of utmost importance.
Integrating new pharmacological molecules, medical devices and the application of new recommendations have major interest for documentation and practical changes.
The main objective of this cohort will be to evaluate the evolution of the 12-month quality of life score of a HF patient and the characteristics and treatments associated with it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patients with congestive heart failure confirmed during
- •Hospitalization for cardiac decompensation
- •A medical follow-up for stable congestive heart failure with at least one cardiac decompensation event
- •NT-proBNP > 500 ng/l in the month before Baseline (or BNP > 150 ng/l)
- •Aged over 18
- •Signature of the informed consent
排除标准
- •Life expectancy shorter than a month
- •Patients on long term assistance or with heart transplant
- •Impossibility to give patients clear information
- •Loss of autonomy, dementia, major dependence
- •Patients without health coverage
- •Patient with no legal protection
- •Pregnant woman
研究组 & 干预措施
Congestive Heart Failure patients Cohort
Cluster of patients with congestive heart failure NYHA ≥2, with at least one cardiac decompensation, NT-proBNP (N-terminal pro-brain natriuretic peptide) > 500 ng/l. Will be followed during 18 months.
干预措施: Blood sampling and Quality of life questionnaire. (Other)
结局指标
主要结局
Change from Baseline Quality of life questionnaire : EuroQol (EQ-5D) at 12 months
时间窗: 12 months
Measurement of quality of life of patients with heart failure: patient will answer to this questionnaire (Mobility, Autonomy of the person, Current activities, Pain ,Anxiéty/Depression) ) at baseline and at 12th month visit. The evolution between these two scores will be analysed .
次要结局
- number all unscheduled hospitalization for heart failure(18 months)
- number of dialysis(18 months)
- Renal function : glomerular filtration rate(2 months)
- number of death (all-cause)(18 months)
- number of all cardiovascular cause death(18 months)
- number of stroke(18 months)
- symptomatic hypotension(18 months)
- Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification(Baseline, 6, 12 and 18 months)
- cardiac assistance or heart transplantation(18 months)
- NT-proBNP(18 months)
- nonfatal myocardial infarction(18 months)
- Cardiac function(Baseline and 12 months)
- number ventricular arrhythmias(18 months)