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

Last updated: December 5, 2023
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT06169540
2022P003352
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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) ≥600pg/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 orParoxysmal 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 orpleural effusions, elevated Jugular Venous Pulse (JVP), lower extremity edema, orrales on pulmonary examination, right heart catheterization evidence of elevatedfilling pressures (Right Atrium (RA) pressure > 10 mmHg; Pulmonary Capillary WedgePressure (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
  • Diagnosis of SVT with planned SVT ablation in the EP lab

Exclusion

Exclusion Criteria:

  • Active pregnancy or lactation
  • Cardiac amyloidosis
  • Active malignancies

Study Design

Total Participants: 90
Study Start date:
April 19, 2023
Estimated Completion Date:
December 31, 2025

Study Description

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 Supraventricular Tachycardia (SVT) patients recruited through the Electrophysiology Lab (EP). For each group, blood plasma and saliva samples will be obtained.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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