Plasma ExtrAcellular RNAs and Biomarkers of Heart FaiLure During Decongestion: PEARL-HF Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Time to stroke or transient ischemic attack
研究概览
简要总结
The primary objective is to measure the association between extracellular RNA (ex-RNA) levels in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac remodeling and (2) cardiovascular events. The investigators will follow patients during standard medical therapy for CHF to assess changes in ex-RNA levels in the plasma, and how these are associated with cardiac remodeling (by cardiac imaging) and outcomes.
详细描述
Nearly 5 million people in the United States have congestive heart failure (CHF). Although medical therapy such as beta-blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs) and aldosterone antagonists has improved prognosis, the overall rate of hospital admissions has continued to rise in the last decade and the mortality for patients with symptomatic heart failure remains worse than the majority of cancers in this country. Accordingly, significant opportunities exist for the improvement in outcomes of patients with CHF, both from a morbidity and mortality standpoint. Such opportunities may lie in the outpatient medical management of patients with CHF.
In this study, the primary objective is to measure the association between extracellular RNA (ex-RNA) levels in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac remodeling and (2) cardiovascular events. The investigators will follow patients during standard medical therapy for CHF to assess changes in ex-RNA levels in the plasma, and how these are associated with cardiac remodeling (by cardiac imaging) and outcomes.
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
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 21 years of age
- •Left ventricular ejection fraction ≤ 50% (at any time in the past)
- •Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level)
- •Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment
排除标准
- •Severe renal insufficiency defined as serum creatinine > 2.5 mg/dl
- •United Organ Network Sharing status 1B for heart transplantation (outpatient inotrope use, LV assist device)
- •Inoperable aortic valvular heart disease
- •Life expectancy <1 year due to causes other than HF such as advanced cancer
- •Cardiac transplantation or revascularization indicated or expected within 6 months
- •Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec <1 L (when diagnosed as standard of care)
- •Subject unable or unwilling to provide written informed consent
- •Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months
结局指标
主要结局
Time to stroke or transient ischemic attack
时间窗: 24 hours
Time to death
时间窗: 24 months
Time to ventricular arrhythmia
时间窗: 24 months
Clinically significant ventricular arrhythmia, defined as ventricular arrhythmia plus one of the following:
Time to acute coronary syndrome
时间窗: 24 months
Myocardial infarction
Time to decompensated heart failure (HF) requiring in-patient admission or ER visit or IV diuretic therapy in the outpatient realm
时间窗: 24 months
• New onset of classic symptoms and signs of destabilized HF, including lower extremity edema, jugular venous distension, bibasilar crackles, orthopnea and paroxysmal nocturnal dyspnea
次要结局
- Change in left ventricular (LV) end-systolic volume (in %)(12 months)
- Change in LV ejection fraction (%)(12 months)
研究者
Saumya Das
Physician
Massachusetts General Hospital