International Multi-center Study to Validate an Early Warning Algorithm for Worsening Heart Failure (NCT04758429) | Clinical Trial Compass
UnknownNot Applicable
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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.