About this trial
The purpose of this study is to determine the relationship between the levels of Ribonucleic acid (RNA) circulating molecules, including ones in extracellular vesicles from different organs in the blood and in the saliva of patients with Acute Decompensated Heart Failure (ADHF) and Chronic Heart Failure (CHF) to see if a new, non-invasive diagnostic test can be developed for heart failure exacerbation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years of age
Stable disease defined as CHF of any type, New York Heart Association (NYHA) functional class II/III/IV, N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥600 pg/ml if Left Ventricular Ejection Fraction (LVEF) ≤30%; ≥1000 pg/mL if LVEF 31-35%; ≥2500 pg/mL if EF >35%
At least 18 years of age
Clinical signs and/or symptoms (including exertional or rest dyspnea, orthopnea or Paroxysmal Nocturnal Dyspnea (PND)) and N-terminal pro-BNP level > 1000 pg/mL or BNP > 400 pg/ml, OR Clinical evidence of congestion: X-ray evidence of pulmonary edema or pleural effusions, elevated Jugular Venous Pulse (JVP), lower extremity edema, or rales on pulmonary examination, right heart catheterization evidence of elevated filling pressures (Right Atrium (RA) pressure > 10 mmHg; Pulmonary Capillary Wedge Pressure (PCWP) > 18 mmHg) and clinical response to Intravenous (IV) diuretic therapy (as judged by a physician)
Disqualifiers
Active pregnancy or lactation
Cardiac amyloidosis
Active malignancies
Trial population
This study will involve patients admitted to the hospital for ADHF, patients with chronic heart failure who are seen in the outpatient clinic, and control patients recruited through the EP lab.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Association between weight change (kg), fluid balance (cumulative fluid intake and output, mL), clinical response to diuretic therapy (as judged by a physician), and salivary biomarker levels assessed by quantitative Polymerase Chain Reaction (qPCR)
Rehospitalization event prediction
Linear regression analysis for biomarker prediction of subsequent hospital admissions.
Association between known biomarkers (NT-proBNP), volume status (right heart catheterization data, echocardiographic data), and salivary biomarker level assessed by qPCR
Sponsors and contacts
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