Plasma ExtrAcellular RNAs and Biomarkers of Heart FaiLure During Decongestion: PEARL-HF Study
Running, not enrolling
Conditions studied: Congestive Heart Failure
In brief
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.
Key facts
- Study ID
- NCT02632656
- Run by
- Massachusetts General Hospital
- People needed
- 400
- Starts
- 2015-12-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-06-17
Who can join
Age: 21 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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