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.
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.
Study Type
OBSERVATIONAL
Enrollment
400
This is a prospective observational study where participants will have serial blood collection on medical therapy for heart failure.
Massachusetts General Hospital
Boston, Massachusetts, United States
Time to death
Time frame: 24 months
Time to decompensated heart failure (HF) requiring in-patient admission or ER visit or IV diuretic therapy in the outpatient realm
• New onset of classic symptoms and signs of destabilized HF, including lower extremity edema, jugular venous distension, bibasilar crackles, orthopnea and paroxysmal nocturnal dyspnea
Time frame: 24 months
Time to acute coronary syndrome
Myocardial infarction
Time frame: 24 months
Time to stroke or transient ischemic attack
Time frame: 24 hours
Time to ventricular arrhythmia
Clinically significant ventricular arrhythmia, defined as ventricular arrhythmia plus one of the following:
Time frame: 24 months
Change in left ventricular (LV) end-systolic volume (in %)
Time frame: 12 months
Change in LV ejection fraction (%)
Time frame: 12 months
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