NCT02008110已完成4 期
A Randomized Controlled Trial of Carbohydrate Antigen 125-guided Therapy Among Patients Recently Discharged for Acute Heart Failure: Effect on 1-year Mortality or Readmission for Acute Heart Failure (CHANCE-HF).
Fundación para la Investigación del Hospital Clínico de Valencia1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Composite of all-cause mortality plus acute heart failure related rehospitalization
研究概览
简要总结
Preliminary data suggest a potential role for monitoring and up-titrate pharmacological therapy of plasma levels of antigen carbohydrate 125 (CA125) following and admission for acute heart failure (AHF).
This study will evaluate the effect of a CA125-guided management strategy versus standard therapy on the composite endpoint of 1-year all-cause mortality or readmission for AHF in patients recently discharged for AHF.
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
- Single (Participant)
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 or older.
- •At least 1 admission for AHF, in the last 180 days.
- •Demonstrates functional New York Heart Association status of Class ≥II at the moment of enrollment.
- •Objective evidence, either during the index admission or at least 180 days before enrollment, of a structural or functional abnormality of the heart at rest, and defined as: N terminal-pro-brain natriuretic peptide >1000 pg/ml or brain natriuretic peptide >100 pg/ml or echocardiographic abnormalities congruent with HF diagnosis such as: systolic left ventricular dysfunction (LVEF <50%); left ventricular hypertrophy (defined as left ventricular septum or left ventricular posterior wall thickness ≥12 millimeters or left ventricular mass index >104 g/m2 in women or 116 g/m2 in men); Ee'>15 or significant valvular heart disease (moderate-severe).
- •A plasma CA125 value >35 U/ml in a recent test evaluation (at least 30 days before enrollment, and preferably assessed before hospital discharge).
- •Patient must be capable of understanding and signing an informed consent form.
排除标准
- •Life expectancy <12 months due to other diseases different from HF.
- •Having undergone a cardiac transplantation, coronary revascularization procedure (percutaneous coronary intervention and/or coronary artery bypass grafting) or cardiac valve replacement in the past 3 months.
- •Angina pectoris higher than class II (Canadian Cardiovascular Society Classification).
- •Pregnancy at the moment of enrollment.
- •Valvular heart disease already scheduled for surgical intervention.
- •Severe chronic obstructive and/or restrictive pulmonary disease, requiring continuous oxygen administration.
- •Serum creatinine level > 3 mg/dl or chronic renal insufficiency on dialysis treatment.
- •Patients receiving resynchronization therapy during the index admission.
- •Significant concurrent medical diseases including cancer or a history of cancer within 5 years of entering the screening period, endometriosis, cirrhosis, acute coronary syndrome within 6 months, uncontrolled hypertension, history of human immunodeficiency virus (HIV) infection, or a significant active infection.
- •Participating in another randomized study.
研究组 & 干预措施
CA125 guided strategy
Experimental
In this group, physician will be encouraged to maximize all treatment measures aimed to keep CA125≤35 U/ml (normal values).
干预措施: CA125 guided strategy (Drug)
Standard treatment strategy
Active Comparator
Therapy is based on established european current guidelines
干预措施: Standard treatment strategy (Drug)
结局指标
主要结局
Composite of all-cause mortality plus acute heart failure related rehospitalization
时间窗: 1 year
次要结局
- Days alive outside of the hospital(1 year)
- Number of heart failure rehospitalizations.(1 year)
- Composite of total mortality plus readmission for any cause(1 year)
- Number of episodes of worsening HF not requiring hospitalization(1-year)
研究者
Julio Nuñez
MD, PhD
Fundación para la Investigación del Hospital Clínico de Valencia
研究点 (1)
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