Prospective and Randomized Comparative Analysis, Between Early or Non-revoked in Day Hospital in Patients With Acute Heart Failure
试验速览
- 阶段
- 不适用
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Comparison of 30-days rehospitalization rate
研究概览
简要总结
Heart failure is one of the major causes of hospitalization in Brazil and worldwide. Recent studies attempt to identify readmission and prognostic markers at the time of discharge from these patients. The reassessment and possibility of early therapeutic adjustment may be relevant in this context. Therefore, the prospective and randomized comparative use of early re-evaluation in Hospital-day versus non-intervention group has not yet been described. The objective of this study was to evaluate the impact on the re-hospitalization rate in 30 days of the early re-evaluation of the patients in the day-hospital versus the non-intervention group in heart failure. For this, a unicentric, randomized and prospective study will be performed, in which the Hospital-Day strategy is performed versus no intervention in a comparative manner. Hospital data (test results, medical outcomes, complications) of patients will be analyzed for safety and effectiveness. The hypothesis of this study is that the Hospital-Day strategy is superior to the non-intervention strategy and causes fewer rehospitalizations within 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adult men and women aged> 18 years.
- •Presence of decomposed CF III or IV of NYHA characterized by> 1 symptom (dyspnea, orthopnea or edema) + 1 clinical sign (rales, edema, ascites or pulmonary congestion on chest X-ray).
- •LVEF <45% on transthoracic echocardiography.
- •BNP> 400 pg / mL.
- •Clinical condition of hospital discharge.
- •Signed consent form.
排除标准
- •Pregnancy
- •Body mass index greater than 40 kg / m
- •Chronic obstructive pulmonary disease.
- •Acute coronary syndrome.
- •Acute myocarditis.
- •Valvular heart disease.
- •Need to use vasoactive drug.
- •Cirrhosis of the liver Child C.
- •Chronic dialysis renal insufficiency or creatinine> 3.0 mg / dL.
- •Indication of implantation device of artificial stimulation.
- •Pulmonary thromboembolism.
- •Neoplasm terminal.
- •Sepsis or septic shock.
研究组 & 干预措施
Hospital Day
Patients in the Hospital-Day group will return for medical evaluation 7-14 days in the specific unit.
干预措施: medical evaluation (Other)
Outpatient clinic
The patients in control group will return for medical evaluation 30 days at the outpatient clinic.
干预措施: medical evaluation (Other)
结局指标
主要结局
Comparison of 30-days rehospitalization rate
时间窗: 30 days
30-days rehospitalization rate
次要结局
- Mortality(30 days)