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Saliva and Blood Markers Studied in Heart Failure Patients

Studies RNA molecules in saliva and blood of adults with heart failure.

Plain-language title generated from the registry record
Registry title: Salivary Extracellular Vesicle Associated lncRNAs in Heart Failure (SEAL-HF)

Key facts

Where
Boston, United StatesSee the site

Where in United States

  • Massachusetts General HospitalBoston, United StatesTaking people

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Trial details

Who runs it
Massachusetts General Hospital
Trial code
NCT06169540
Record updated
13 November 2025
Original description
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.Read full original descriptionShow less

Salivary Extracellular Vesicle Associated lncRNAs in Heart Failure (SEAL-HF)

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.

Inclusion: 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); At least 18 years of age; Will/have undergone an EP procedure in the EP lab.

Exclusion: Cardiac amyloidosis; Active malignancies; Active pregnancy or lactation.

ClinicalTrials.gov NCT06169540