NCT02632656Active, not recruiting
Plasma ExtrAcellular RNAs and Biomarkers of Heart FaiLure During Decongestion: PEARL-HF Study
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 11 Dec 2015
- Start date
- Dec 2015
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Heart failure
- NCT number
- NCT02632656
What you commit to
- Study type: Observational
- Planned participants: 400
- From Dec 2015 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months
Other illness
- 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)
Lab values
- Severe renal insufficiency defined as serum creatinine \> 2.5 mg/dl
Other
- Subject unable or unwilling to provide written informed consent
Who the study is looking for
- 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
Age in the registry: 21 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.