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Salivary Extracellular Vesicle Associated lncRNAs in Heart Failure (SEAL-HF)
NCT06169540 · Massachusetts General Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
The primary objective of this study is to investigate the expression of extracellular vesicle RNAs (evRNAs) during admission for and decongestion of ADHF patients and determine their diagnostic and prognostic potential. The main hypothesis is that these evRNAs are dynamically regulated in response to volume status changes. Thus, the aim is to delineate: i) the utility of salivary evRNA expression in discriminating ADHF from compensated chronic heart failure states in ADHF patients, chronic heart failure patients and controls (n=30 each); and ii) assess changes in expression in ADHF patients during decongestion. Plasma and salivary evRNA levels will be correlated to determine accuracy of salivary Extracellular Vesicles (EVs) to reflect changes in plasma.
This is a multi-cohort study that will make use of clinical saliva and plasma samples of 90 subjects across three groups. The first group will consist of 30 patients admitted to the hospital for ADHF (clinical samples will be collected during acute decompensation and after diuresis of ADHF patients). The second group will consist of 30 patients with chronic heart failure who are seen in the outpatient clinic. The control group will also include 30 patients undergoing electrophysiology procedures recruited through the Electrophysiology Lab (EP). For each group, blood plasma and saliva samples will be obtained.
Eligibility 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
Study design
Enrollment target: 90 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-04-19
Estimated completion: 2027-12-31
Last updated: 2025-11-13
Primary outcomes
- • 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 prediction (Through study completion, an average of 1 year)
- • Association between known biomarkers (NT-proBNP), volume status (right heart catheterization data, echocardiographic data), and salivary biomarker level assessed by qPCR (Through study completion, an average of 1 year)
Sponsor
Massachusetts General Hospital · other
Contacts & investigators
ContactSaumya Das, MD, PhD · contact · sdas@mgh.harvard.edu · 617-724-4500
ContactPriyanka Gokulnath, PhD · contact · PGOKULNATH@mgh.harvard.edu
InvestigatorMichail Spanos, MD · study_director, Massachusetts General Hospital
All locations (1)
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States