ADHERE (Acute Decompensated Heart Failure National Registry) Longitudinal Module-Registry of Advanced Heart Failure Patients at High Risk for Rehospitalization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Scios, Inc.
- 入组人数
- 1,466
- 主要终点
- The primary outcome are length of hospitalization and/or time to death
研究概览
简要总结
The purpose of this study is to gather information to better understand the characteristics, medical management techniques and outcomes of patients with chronic severe Heart Failure (HF).
详细描述
This objectives of this observational registry are: to assess changes in patient quality of life as a function of medical management and disease progression as measured by the rate of death and rehospitalization, and assist with the optimization of heart failure (HF) management by providing information on the use of therapies proven to be effective and to describe practices of standard of care for chronic treatment of symptoms of HF outside the hospital and during hospitalization for acute episode with intravenous vasoactive medication (drugs which affect the blood vessels and muscle of the heart). Additional information which will be gathered include patient characteristics (age, sex, race, medical history, symptoms), infusion setting, type of medication, dose and frequency of medication and worsening of congestive heart failure disease. Participants in the study receive an unique patient-specific identifier and all available data will be analyzed. Observational Study - No investigational drug administered
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 older than or equal to 18 years at the time of entry into the Registry
- •Severe symptoms of HF at rest with marked limitation of physical activity continuously for at least 60 days prior to inclusion in the Registry
- •Patient has been hospitalized 2 times in the past 12 months with a primary diagnosis of HF
- •Patient's HF is refractory or relatively refractory to usual non-IV medications, as defined by having received one of the two following regimens for the treatment of HF in that last 60 days: 2 complete IV infusions, each lasting at least 2 hours, of either vasoactive (drugs having an effect on veins or arteries) or inotrope medications (drugs that makes the heart works better), or 3 IV diuretic (drugs that increase the elimination of urine) treatments
排除标准
- •History of any organ transplantation
- •Patient is expected to die within the next 5 days
- •Patient is seen for consultation or evaluation only, and is unlikely to receive follow-up care at the participating clinic/hospital
- •Participation in a clinical study of the drug Natrecor
结局指标
主要结局
The primary outcome are length of hospitalization and/or time to death
时间窗: Patients data are collected for 2 years. Data are collected for all scheduled and unscheduled office visits, and each hospitalization. Individual patient questionnaires are completed at baseline and every 3 months thereafter.
次要结局
- Evaluation of medication and other treatment received(every 3 months)
- Evaluation of laboratory results(evey 3 months)