Investigating Salivary RNA for Heart Failure Diagnosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.