Salivary Extracellular Vesicle Associated lncRNAs in Heart Failure (SEAL-HF)
NCT ID: NCT06169540
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
90 participants
OBSERVATIONAL
2023-04-19
2027-12-31
Brief Summary
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Detailed Description
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This is a multi-cohort study that will make use of clinical saliva and plasma samples of 90 subjects across three groups. The first group will consist of 30 patients admitted to the hospital for ADHF (clinical samples will be collected during acute decompensation and after diuresis of ADHF patients). The second group will consist of 30 patients with chronic heart failure who are seen in the outpatient clinic. The control group will also include 30 patients undergoing electrophysiology procedures recruited through the Electrophysiology Lab (EP). For each group, blood plasma and saliva samples will be obtained.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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ADHF
Patients with ADHF (during admission and discharge).
No interventions assigned to this group
CHF
Patients with CHF.
No interventions assigned to this group
Control
Patients undergoing electrophysiology procedures.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Cardiac amyloidosis
* Active malignancies
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Saumya Das
Director, Resynchronization and Advanced Cardiac Therapeutics Program, Massachusetts General Hospital; Associate Professor of Medicine, Harvard Medical School
Principal Investigators
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Michail Spanos, MD
Role: STUDY_DIRECTOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Saumya Das, MD, PhD
Role: primary
Other Identifiers
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2022P003352
Identifier Type: -
Identifier Source: org_study_id