NCT06169540Recruiting
Salivary Extracellular Vesicle Associated lncRNAs in Heart Failure (SEAL-HF)
Source: ClinicalTrials.gov · Last updated 13 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 16 Nov 2023
- Start date
- 19 Apr 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Heart failure
- NCT number
- NCT06169540
What you commit to
- Study type: Observational
- Planned participants: 90
- From 19 Apr 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cardiac amyloidosis
- Active malignancies
Other
- Active pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.