Status:
RECRUITING
Salivary Extracellular Vesicle Associated lncRNAs in Heart Failure (SEAL-HF)
Lead Sponsor:
Massachusetts General Hospital
Conditions:
CHF
ADHF
Eligibility:
All Genders
18+ years
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 blo...
Detailed 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 pr...
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) ≥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
Exclusion
Key Trial Info
Start Date :
April 19 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06169540
Start Date
April 19 2023
End Date
December 31 2027
Last Update
November 13 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114