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Observational Study on Salivary RNA in Heart Failure (SEAL-HF)

This study, called SEAL-HF, is looking into whether certain RNA molecules found in your saliva could help doctors diagnose and predict problems in people with heart failure. Researchers want to see if these RNA levels change when heart failure gets worse (Acute Decompensated Heart Failure or ADHF) or stays stable (Chronic Heart Failure or CHF). They will compare saliva samples from people with ADHF, CHF, and healthy individuals. The goal is to develop a simple, non-invasive (meaning it doesn't involve needles or surgery) test to better manage heart failure. To join, you must be at least 18 years old and have either stable CHF or ADHF, with specific levels of a heart failure biomarker called NT-proBNP. The study aims to enroll 90 participants.

Study design
This is an observational study involving 90 participants across three groups: ADHF patients, CHF patients, and a control group. It is not a randomized or blinded study.
What's involved
You would provide blood plasma and saliva samples. For ADHF patients, samples will be collected during acute decompensation and after treatment. For CHF and control groups, samples will be taken during clinic visits or electrophysiology procedures.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants through completion, which is an average of one year, to assess rehospitalization events and associations with salivary biomarker levels.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06169540

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

Recruiting
Not specifiedAges 18+Observational
Massachusetts General Hospital
~90 participants
Updated 2025-11-13 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over Through study completion, an average of 1 year
+2 more outcomes measured

Conditions

CHF
ADHF
Control

Explore related trials

Chronic heart failureDecompensated chronic heart failure

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Michail Spanos, MD · STUDY_DIRECTOR · Massachusetts General Hospital

Who to contact

Saumya Das, MD, PhD
[email protected]
617-724-4500
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

Active pregnancy or lactation
Cardiac amyloidosis
Active malignancies

What this trial measures

  • 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)Through study completion, an average of 1 year
  • Rehospitalization event predictionThrough study completion, an average of 1 year

    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 qPCRThrough study completion, an average of 1 year