Plasma ExtrAcellular RNAs and Biomarkers of Heart FaiLure During Decongestion: PEARL-HF Study

NCT02632656 | Active Not Recruiting

• 1 other identifier: 2015P001658
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (5)

• Time to death

  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

  24 months

• Time to acute coronary syndrome

  Myocardial infarction

  24 months

• Time to stroke or transient ischemic attack

  24 hours

• Time to ventricular arrhythmia

  Clinically significant ventricular arrhythmia, defined as ventricular arrhythmia plus one of the following:

  24 months

Secondary Outcomes (2)

• Change in left ventricular (LV) end-systolic volume (in %)

  12 months

• Change in LV ejection fraction (%)

  12 months

Study Arms (1)

Patients with congestive heart failure

Patients with congestive heart failure (CHF) who are followed in the hospital or clinic setting, with optimization of medical therapy

Other: Monitoring on heart failure therapy

Interventions

Monitoring on heart failure therapy OTHER

This is a prospective observational study where participants will have serial blood collection on medical therapy for heart failure.

Patients with congestive heart failure

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 200 eligible subjects. These subjects will be enrolled from the Massachusetts General Heart Failure Center population, from the Yawkey Center for Outpatient Care, upon discharge from the inpatient services at Massachusetts General Hospital.

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood collected at various time points during CHF therapy, processed for ex-RNAs

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 17, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

US (1)