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

Control Clinical Trial

— SEAL-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06169540
• Other study ID #: 2022P003352
• Status: Recruiting
• Start date: April 19, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: Saumya Das, MD, PhD
• Phone: 617-724-4500
• Email: sdas[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Diagnosis of SVT with planned SVT ablation in the EP lab

Exclusion Criteria:

• Active pregnancy or lactation

• Cardiac amyloidosis

• Active malignancies

Related Conditions & MeSH terms

• ADHF
• CHF
• Control
• Heart Failure

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Rehospitalization event prediction	Linear regression analysis for biomarker prediction of subsequent hospital admissions.	Through study completion, an average of 1 year
Primary	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