Comparison of Patient Care Management Strategies of Heart Failure in the Rhône-Alpes Region. A Clinical and Economic Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Composite endpoint combining the proportion of patients who died, the proportion of hospitalization for heart failure as well as the proportion of emergency visits for heart failure.
研究概览
简要总结
The heart failure is a chronic pathology with prevalence from 2 to 3% of general population, a death rate of 50% at 6 months for patients with stage IV, and a probability of death or hospitalization or emergency consultation of 40% at 3 years. The care of patients is heterogeneous, especially in light of the organization of therapeutic education offered to patients and patient monitoring modalities.
The aim of this study is to investigate the management strategies for patients with chronic heart failure stage III or IV NYHA, and heart failure patients with stage II NYHA with previous hospitalization for heart failure.
This is a longitudinal observational multicenter study comparing a management strategy including patient education and monitoring as part of a hospital dedicated organization and an organization of care as usually done in France.
The primary endpoint was a composite endpoint of morbidity and mortality involving deaths, unplanned readmissions and emergency visits for heart failure.
The expected number of patients is 720 patients (360 per strategy). The follow-up duration of 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic heart failure patient with left ventricular ejection fraction (LVEF) defined by an impaired LVEF less than or equal to 40%.
- •Heart failure stage III or IV NYHA, or heart failure patients with stage II NYHA with previous hospitalization for heart failure.
- •Patient who has received a written or oral information of the study
- •Patient affiliated with French health Insurance
排除标准
- •Patient refusal to participate in the study
- •Progressive neoplastic pathology.
- •Patient with impaired cognitive functions known.
- •Patient subject to a measure of socio-legal protection.
- •Heart failure secondary to curable causes (an arrhythmia, valvular dysfunction, myocardial infarction, bypass surgery scheduled, aortic stenosis, breaking rope...)
- •Dyspnea pulmonary origin: pulmonary arterial hypertension pre-capillary origin catheterization, defined by a Pcap ≤15 mmHg.
- •Patient who underwent ventricular mechanical assistance.
- •Patient with acute breathlessness is explained by: a severe lung infection (CPT <60% of predicted, ventricular ejection fraction <60% predicted) or pulmonary embolism or respiratory failure with ambient air PaO2 (arterial oxygen pressure) below 60 mmHg or oxygen therapy.
- •Dialysis patient
研究组 & 干预措施
Interventional
PRETICARD patient care management
干预措施: PRETICARD patient care management (Other)
Control
Heterogenous "as usual" patient care management.
干预措施: "As usual " patient care management (Other)
结局指标
主要结局
Composite endpoint combining the proportion of patients who died, the proportion of hospitalization for heart failure as well as the proportion of emergency visits for heart failure.
时间窗: 12 months
次要结局
- Unplanned re hospitalization rate or emergency consultations for cardiac insufficiency.(At 6, 18 and 24 months)
- Cost of medical care(24 months)
- Quality of life.(12 months)
- Satisfaction.(3 months)