Salivary Extracellular Vesicle Associated lncRNAs in Heart Failure (SEAL-HF)
Recruiting · NCT06169540 · Observational (researchers observe without assigning treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States