International Multi-center Study to Validate an Early Warning Algorithm for Worsening Heart Failure (NCT04758429) | Clinical Trial Compass
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International Multi-center Study to Validate an Early Warning Algorithm for Worsening Heart Failure
552 participantsStarted 2021-05-31
Plain-language summary
The study is a multi-center, prospective, non-randomized, observational study to collect data to develop and validate a machine learning algorithm for early detection of worsening heart failure events using multi-parametric sensor data from wearable data capture device The VESTA study will enroll up to 552 subjects in up to 25 centers in order to collect data on a total of at least 56 worsening heart failure events (independently adjudicated hospitalizations or unscheduled intravenous administration of decongestive drugs).The duration of follow-up per participant will be between 3-6 months.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years of age and above
* New York Heart Association(NYHA) functional class II-IV
* Reduced ejection fraction (HFrEF) with left ventricular ejection fraction (LVEF) ≤40%
* History of chronic HF as evidenced by
* LVEF ≤40% measured at least 30 days before enrollment
* N-terminal-pro hormone brain-type natriuretic peptide (NT-proBNP) \> 500 pg/mL OR brain-type natriuretic peptide (BNP) \>150 pg/mL; tested no longer than one month prior to inclusion.
* At increased risk for HF decompensation as defined by
* currently inpatient with hospital admission due to HF decompensation (acute on chronic heart failure), or
* history of hospitalization for HF decompensation in the last 6 months
* Understands the study requirements and the study procedures and provides written informed consent before any trial-specific tests or procedures are performed
Exclusion Criteria:
* Known allergy to any component of the study device (cotton, elastane, polyester)
* Current HF hospitalization due to acute de novo heart failure
* Current HF decompensation due to triggers like surgery or perioperative complications, pulmonary embolic episode or acute myocardial infarction
* Severe chronic kidney disease with glomerular filtration rate (GFR) \<30 ml/ min/1.73 m2 and/or renal replacement therapy
* Evidence of hepatic disease as determined by any one of the following: serum glutamic-oxaloacetic transaminase (SGOT/AST) or serum glutamic-pyruvic transaminase (SGPT/ALT) valu…