Salivary Extracellular Vesicle Associated lncRNAs in Heart Failure (SEAL-HF)

NCT06169540 | Recruiting

• 1 other identifier: 2022P003352
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CHF; ADHF; Control

Outcome Measures

Primary Outcomes (3)

• 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

  Linear regression analysis for biomarker prediction of subsequent hospital admissions.

  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

Study Arms (3)

ADHF

Patients with ADHF (during admission and discharge).

CHF

Patients with CHF.

Control

Patients undergoing electrophysiology procedures.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will involve patients admitted to the hospital for ADHF, patients with chronic heart failure who are seen in the outpatient clinic, and control patients recruited through the EP lab.

You may qualify if:

• 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

You may not qualify if:

• Active pregnancy or lactation
• Cardiac amyloidosis
• Active malignancies

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva and plasma samples.

Study Officials

• Michail Spanos, MD

  Massachusetts General Hospital

  STUDY DIRECTOR

Central Study Contacts

Saumya Das, MD, PhD

CONTACT

617-724-4500; sdas@mgh.harvard.edu

Priyanka Gokulnath, PhD

CONTACT

PGOKULNATH@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Resynchronization and Advanced Cardiac Therapeutics Program, Massachusetts General Hospital; Associate Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 13, 2023
• Study Start: April 19, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)