Recruiting

Heart Failure

Sponsor:

Massachusetts General Hospital

Code:

NCT06169540

Conditions

CHF

ADHF

Control

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06169540

Start date

Apr 19, 2023

Status verified date

Nov, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

90 participants

Anticipated

Interventions and Outcome Measures

Arms

ADHF

Patients with ADHF (during admission and discharge).

CHF

Patients with CHF.

Control

Patients undergoing electrophysiology procedures.

Primary outcome measure

  • 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) [ Time Frame: Through study completion, an average of 1 year ]
  • Rehospitalization event prediction [ Time Frame: 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 [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Saumya Das, MD, PhD

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

Priyanka Gokulnath, PhD

PGOKULNATH@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Saumya Das, MD, PhD

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

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-13.