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

Congestive Heart Failure Clinical Trial

— PEARL-HF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02632656
• Other study ID #: 2015P001658
• Status: Active, not recruiting
• Start date: December 2015
• Est. completion date: December 1, 2025

Study information

• Verified date: July 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Age > 21 years of age

2. Left ventricular ejection fraction = 50% (at any time in the past)

3. Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level)

4. Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment

Exclusion Criteria:

1. Severe renal insufficiency defined as serum creatinine > 2.5 mg/dl

2. United Organ Network Sharing status 1B for heart transplantation (outpatient inotrope use, LV assist device)

3. Inoperable aortic valvular heart disease

4. Life expectancy <1 year due to causes other than HF such as advanced cancer

5. Cardiac transplantation or revascularization indicated or expected within 6 months

6. Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec <1 L (when diagnosed as standard of care)

7. Subject unable or unwilling to provide written informed consent

8. Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to death		24 months
Primary	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
Primary	Time to acute coronary syndrome	Myocardial infarction	24 months
Primary	Time to stroke or transient ischemic attack		24 hours
Primary	Time to ventricular arrhythmia	Clinically significant ventricular arrhythmia, defined as ventricular arrhythmia plus one of the following:	24 months
Secondary	Change in left ventricular (LV) end-systolic volume (in %)		12 months
Secondary	Change in LV ejection fraction (%)		12 months