Investigating Salivary RNA for Heart Failure Diagnosis
Salivary Extracellular Vesicle Associated lncRNAs in Heart Failure (SEAL-HF)
This study is testing whether levels of certain RNA in saliva can help doctors tell the difference between acute and chronic heart failure in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06169540 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between extracellular vesicle-associated RNA levels in saliva and blood among patients with Acute Decompensated Heart Failure (ADHF), Chronic Heart Failure (CHF), and a control group. The primary objective is to assess the diagnostic and prognostic potential of salivary RNA in distinguishing between ADHF and compensated CHF states. By collecting clinical samples from 90 subjects across three groups, the study will analyze how RNA expression changes during treatment and recovery from heart failure exacerbations. The findings could lead to the development of a non-invasive diagnostic test for heart failure.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with either Acute Decompensated Heart Failure or Chronic Heart Failure.
Not a fit: Patients with stable heart conditions not meeting the inclusion criteria for heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, non-invasive method for diagnosing and monitoring heart failure exacerbations.
How similar studies have performed: While the approach of using salivary RNA for diagnostic purposes is innovative, similar studies have shown promise in other contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria CHF: * 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% Inclusion Criteria ADHF: * 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) Inclusion Criteria control: * At least 18 years of age * Will/have undergone an EP procedure in the EP lab Exclusion Criteria: * Active pregnancy or lactation * Cardiac amyloidosis * Active malignancies
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Saumya Das, MD, PhD
- Email: sdas@mgh.harvard.edu
- Phone: 617-724-4500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.