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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Dec 5, 2023

Keywords

ClinConnect Summary

The SEAL-HF clinical trial is investigating how certain molecules called RNAs, found in blood and saliva, relate to heart failure, specifically in patients experiencing Acute Decompensated Heart Failure (ADHF) and Chronic Heart Failure (CHF). The goal is to see if these RNAs can help create a new, simple test that can quickly identify when heart failure symptoms worsen, making it easier for doctors to manage the condition.

To participate in this study, individuals must be at least 18 years old and have a diagnosis of either CHF or ADHF. For those with CHF, their heart function must be stable, while ADHF participants need to show clear signs of worsening heart failure. The trial is currently recruiting participants and welcomes individuals of all genders. If you join, you can expect to provide samples of your saliva and blood, which will be analyzed to find out more about your heart condition. It's important to note that certain individuals, such as those who are pregnant or have specific heart conditions, may not be eligible to participate.

Gender

ALL

Eligibility criteria

• 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