Chronic Heart FailureVESTANCT04758429
International Multi-center Study to Validate an Early Warning Algorithm for Worsening Heart Failure
An observational study of Chronic Heart Failure, run by Chronolife.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Machine-learning Algorithm
- Type of treatment
- Medical device
- How many people
- 552 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2021to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be enrolling male and female patients with history of chronic heart failure.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
Dominique Dury contact
About this study
Official title: Validating the Ability for Early Recognition of Worsening Heart Failure by a System Technology of Automated Prediction From Multi-sensor Data: A Prospective, Open-label, Single-arm, International, Multi-center Clinical Study
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.
Read the 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 automated learning algorithm; the second phase is to validate the algorithm.
The participants will be assigned into two cohorts:
- Cohort 1 will provide the data to be used for algorithm development and training.
- Cohort 2 will provide data to be used for algorithm validation.
It has been estimated that approximately 276 subjects are required for each cohort in order to accumulate the minimum number of cases for the study's primary objective. Sequential enrolment will be implemented by regional blocks according to an estimation of the regional distribution of subjects.The sample size and regional distribution of subjects are estimates and the study is endpoint driven to achieve at least 28 WHF events with corresponding analyzable device data. Fewer subjects may be enrolled should the required number of events be acquired at a faster rate than calculated and the regional proportions of subjects may vary according to regional enrollment rates.
All participants will undergo the same study procedures, irrespective of their cohort assignment. Each subject will receive the study device kit (garment and smart phone with charger) at enrollment and will be followed up for up to 6 months, or until at least 28 worsening heart failure (WHF) events per cohort have been acquired. Even if the required number of events have been acquired, all participants will be followed up for a minimum of at least 3 months.
The study will collect data; however no data collected by the device will be made available to clinical care personnel during the study and as such no medical action will be taken based on the device. Medical follow-up will be according to standard practice as per each investigational site, which will be documented AND there will be no additional medical intervention on the study participants. The participants are required to agree to be compliant with the use of the device.
There is no masking of device allocation or procedures. However, the clinical investigators, treating physicians and the independent clinical events adjudication committee (IEAC) members will be blinded to all sensor data throughout the study.
The investigators developing the algorithm will have no access to the validation cohort database before the parameters of the algorithm have been fixed by the training cohort.
- Conditions
- Chronic Heart Failure
- Being tested
- Machine-learning Algorithm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Machine-learning AlgorithmDevice
System technology/Software
| Study group | Role | What they receive |
|---|---|---|
| Development or Training Cohort | will provide the data to be used for algorithm development and training. Receives: Device: Machine-learning Algorithm | |
| Test or Validation Cohort | will provide data to be used for algorithm validation. Receives: Device: Machine-learning Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of worsening heart failure (WHF) event
Sensitivity and Specificity of detection of WHF event by a machine-learning algorithm system using multi-parametric data captured by non-invasive telemonitoring.
WHF event definition:
- Any hospital admission for WHF(e.g. due to new or progressive symptoms/signs of decompensated HF including significant weight gain, worsening dyspnea or fatigue, newly elevated jugular venous pressure, new cardiac S3 gallop rhythm, the development of pulmonary rales, hepatic congestion or lower extremity edema), OR
- Any administration of intravenous HF therapy in an unscheduled setting (e.g. clinic/office/emergency department, ED).
Measured: 6 months
Secondary outcomes (7)
Hospitalizations for HF that did not meet WHF
Algorithm System Detection of HF-associated health care utilization events not eligible to be considered as primary events
Number of days hospitalized for HF (total number of days and per hospitalization)
Measured: 6 months
HF-hospitalization in number of days
System Detection of HF-associated health care utilization events not eligible to be considered as primary events
Number of days hospitalized for HF (total number of days and per hospitalization)
Measured: 6 months
Outpatient health encounters leading to changes or adjustments of oral HF medication
Algorithm System Detection of HF-associated health care utilization events not eligible to be considered as primary events
Measured: 6 months
Other healthcare encounters do not meet criteria of WHF event, points a, b and c but are deemed related to HF
Algorithm System Detection of HF-associated health care utilization events not eligible to be considered as primary events
Measured: 6 months
Number of Adverse and Serious Adverse Events known to be associated with wearable devices with sensors
General device safety will be assessed through adverse event monitoring
Measured: Occuring during the 6 month follow-up
Acceptability and usability of study data capture device assessed by Study Ergonomics and Usability Questionnaire
Patient-reported data in Ergonomics and Usability Questionnaire administered at monthly intervals.
A Likert-like scale is used for scoring, with scores of 1-5, with higher scores signifying agreement with the questions.
Measured: 6 months
Frequency and duration of study data capture device assessed by Study Frequency and duration of use Questionnaire
Patient-reported data in Frequency and duration of use Questionnaire administered at monthly intervals.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start31 May 2021 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chronolife
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758429
- Sponsor's protocol ID
- PREDIGMA001
- Acronym
- VESTA
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating the Ability for Early Recognition of Worsening Heart Failure by a System Technology of Automated Prediction From Multi-sensor Data: A Prospective, Open-label, Single-arm, International, Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT04758429
- Acronym / sponsor ID
- VESTA / PREDIGMA001
- Conditions
- Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- ChronolifeIndustry (pharma, biotech, devices)
- Study start
- 31 May 2021 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 automated learning algorithm; the second phase is to validate the algorithm.
The participants will be assigned into two cohorts:
- Cohort 1 will provide the data to be used for algorithm development and training.
- Cohort 2 will provide data to be used for algorithm validation.
It has been estimated that approximately 276 subjects are required for each cohort in order to accumulate the minimum number of cases for the study's primary objective. Sequential enrolment will be implemented by regional blocks according to an estimation of the regional distribution of subjects.The sample size and regional distribution of subjects are estimates and the study is endpoint driven to achieve at least 28 WHF events with corresponding analyzable device data. Fewer subjects may be enrolled should the required number of events be acquired at a faster rate than calculated and the regional proportions of subjects may vary according to regional enrollment rates.
All participants will undergo the same study procedures, irrespective of their cohort assignment. Each subject will receive the study device kit (garment and smart phone with charger) at enrollment and will be followed up for up to 6 months, or until at least 28 worsening heart failure (WHF) events per cohort have been acquired. Even if the required number of events have been acquired, all participants will be followed up for a minimum of at least 3 months.
The study will collect data; however no data collected by the device will be made available to clinical care personnel during the study and as such no medical action will be taken based on the device. Medical follow-up will be according to standard practice as per each investigational site, which will be documented AND there will be no additional medical intervention on the study participants. The participants are required to agree to be compliant with the use of the device.
There is no masking of device allocation or procedures. However, the clinical investigators, treating physicians and the independent clinical events adjudication committee (IEAC) members will be blinded to all sensor data throughout the study.
The investigators developing the algorithm will have no access to the validation cohort database before the parameters of the algorithm have been fixed by the training cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Development or Training Cohort | – | Device: Machine-learning Algorithmwill provide the data to be used for algorithm development and training. |
| Test or Validation Cohort | – | Device: Machine-learning Algorithmwill provide data to be used for algorithm validation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be enrolling male and female patients with history of chronic heart failure.
Key inclusion criteria (10 listed)
- 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
- At increased risk for HF decompensation as defined by
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Machine-learning AlgorithmSystem technology/Software | Device | Development or Training Cohort, Test or Validation Cohort |
Primary outcome
Detection of worsening heart failure (WHF) event
Time frame: 6 months
Sensitivity and Specificity of detection of WHF event by a machine-learning algorithm system using multi-parametric data captured by non-invasive telemonitoring. WHF event definition: * Any hospital admission for WHF(e.g. due to new or progressive symptoms/signs of decompensated HF including significant weight gain, worsening dyspnea or fatigue, newly elevated jugular venous pressure, new cardiac S3 gallop rhythm, the development of pulmonary rales, hepatic congestion or lower extremity edema), OR * Any administration of intravenous HF therapy in an unscheduled setting (e.g. clinic/office/emergency department, ED).
7 secondary outcomes
Hospitalizations for HF that did not meet WHF
Time frame: 6 months
HF-hospitalization in number of days
Time frame: 6 months
Outpatient health encounters leading to changes or adjustments of oral HF medication
Time frame: 6 months
Other healthcare encounters do not meet criteria of WHF event, points a, b and c but are deemed related to HF
Time frame: 6 months
Number of Adverse and Serious Adverse Events known to be associated with wearable devices with sensors
Time frame: Occuring during the 6 month follow-up
Acceptability and usability of study data capture device assessed by Study Ergonomics and Usability Questionnaire
Time frame: 6 months
Frequency and duration of study data capture device assessed by Study Frequency and duration of use Questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Dury contact
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Chronolife.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zarifah Reed, MD (+33665038601, zreed@chronolife.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of worsening heart failure (WHF) event (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.