RISK Stratification Using a Combination of Cardiac Troponin T and Brain Natriuretic Peptide in Patients Receiving CRT-D
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- All Cause Death
研究概览
简要总结
The purpose of the study is to identify if the combined use of cardiac troponin enzyme (cTnT) and brain natriuretic peptide (BNP) can predict Heart Failure (HF)improvement and all-cause mortality in patients implanted with cardiac pacemaker-defibrillation devices (CRT-D). Novel biochemical markers identifying patients with high risk cardiac mortality detected by plasma protein analysis will also be evaluated.
Hypothesis #1: The combined use of cTnT and BNP at just before implant will predict and risk stratify all cause mortality or HF hospitalization up to 12 months.
Hypothesis #2: The change in levels of said biomarkers at different points of follow-up can predict response to CRT through 12 months.
Hypothesis #3: The levels of a panel of novel inflammatory mediators, namely chemokines, will be correlated with improvement in 6-minute walk testing, quality of life, and left ventricular ejection fraction in CRT patients.
详细描述
Primary Endpoint
The primary endpoint is the occurrence of either death or first HF hospitalization. HF hospitalizations must satisfy both of the following criteria:
- Admission to hospital for >24 hours with at least one of the following HF worsening symptoms:
- Increased CHF class
- Orthopnea
- Paroxysmal nocturnal dyspnea
- Edema
- Dyspnea on exertion, or
- Gastrointestinal (GI) symptoms attributable to HF
- Placement on the Status I heart transplant list
AND 2. One or more of the following intensive treatment(s) for HF within 24 hours of admission:
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred for implantation of CRT-D according to currently accepted guidelines.
- •18 years or older
- •Ability to independently comprehend and complete a QOL questionnaire
- •Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up
- •Has stable conventional medications at least one month prior to enrollment
排除标准
- •Inability to successfully implant an intravascular lead CRT-D device. (i.e. exclude epicardial leads)
- •Myocardial infarction or unstable angina in the last 3 weeks
- •Chronic atrial fibrillation (continuous AF lasting > 1 Month) within 1 year prior to enrollment or having undergone cardioversion for AF in the past month
- •Status 1 classification for cardiac transplantation
- •Currently participating in a clinical trial that includes an active treatment arm
- •Life expectancy of less than 6 months.
- •Recent (within 24 hours) administration of Nesiritide™
结局指标
主要结局
All Cause Death
时间窗: 1 year follow up
First Heart Failure Hospitalization
时间窗: 1 year follow up
次要结局
- • Cause of death and ejection fraction(1 year follow up)