Status:
UNKNOWN
International Multi-center Study to Validate an Early Warning Algorithm for Worsening Heart Failure
Lead Sponsor:
Chronolife
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
The study is an international, multicenter, prospective, open-label, non-randomized single group study, with no control group. The study has 2 phases: the first phase is to train and develop the auto...
Eligibility Criteria
Inclusion
- 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
- 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) values exceeding 3x upper limit of normal, bilirubin \>1.5 mg/dl
- Body mass index (BMI)\>35 kg/m2
- Planned surgery or other procedures within 6 months after the inclusion
- Severe uncorrected valvular heart disease, or hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
- Receiving mechanical circulatory support
- Candidates on heart transplant list
- Factors or conditions, that according to investigator assessment may affect compliance with protocol or cause confound data interpretation. Examples may include but are not limited to:
- Cardiac conditions or interventions such acute coronary syndrome, major cardiovascular surgery including coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI) or implantation of a cardiac resynchronization therapy (CRT) device within 3 months prior to inclusion, or having certain implanted cardiac devices that affect cardiac condition or circulation,
- Other serious medical illness (e.g., cancer) with estimated life expectancy of less than 12 months.
- Current problems with substance addiction
- Participating in another investigational drug or device clinical trial
- Pregnant or nursing
Key Trial Info
Start Date :
May 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2022
Estimated Enrollment :
552 Patients enrolled
Trial Details
Trial ID
NCT04758429
Start Date
May 31 2021
End Date
May 31 2022
Last Update
February 17 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.