Heart FailureWEAR-HFNCT06335264
A Multimodal Wearable Platform for Heart Failure Disease Stratification
An observational study of Heart Failure, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The purpose of this study is to find out if there are any patterns in the way people's bodies react to physical activities and their voices when they have heart failure, a disease where the heart cannot function sufficiently. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Watch HOP
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2024to 31 Aug 2025
- How long will I take part?
- 6 Months
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Case group will be enrolled from the cardiology clinics at the Royal Victoria Hospital (located at MUHC). Patients will be screened for on the clinic lists on a daily basis. The attending physician will be asked if the patient is suitable for enrollment. The participant will be approached, and the informed consent will be taken before enrollment. 2. Control group will be recruited from both the cardiology clinics (patients without heart failure) and Cortois Cardiovascular Signature Program, also at the Royal Victoria Hospital. Patients will be screened for on the clinic lists on a daily basis. The attending physician will be asked if the patient is suitable for enrollment. The participant will be approached, and the informed consent will be taken before enrollment.
Who may be able to join
- Able to follow up with the study protocol schedule
- Life expectancy > 1 year
- Case group only
- Clinical signs and/or symptoms of heart failure caused by a structural and/or functional cardiac abnormality, as defined by Bozkurt et al. [2021], diagnosed at the cardiovascular clinic
- NT-proBNP levels > 125 pg/L or objective evidence of cardiogenic pulmonary or systemic congestion
- One of the following;
Show all 10Show fewer
- For HFpEF, LVEF ≥ 50% ii. For HFmrEF, LVEF 41-49% iii. For HFrEF, LVEF ≤ 40%
- Control group only
- Absence of known clinical heart failure history.
- Absence of criteria above in the case group.
Who cannot join
- Any person who does not meet the above criteria or who refuses to participate
- Undergoing chemotherapy or dialysis
- In addition, the following list of criteria are specific to accurate wrist wearable measurements:
- Skin burns or rashes on the measurement locations (wrist for wearable, finger for oximeter, chest for Polar ECG)
- Patients with tremors
- Recent use of dermatological creams, ointments, or lotions at the recording area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Heart Failure Using a Multimodal Wearable Device
The purpose of this study is to find out if there are any patterns in the way people's bodies react to physical activities and their voices when they have heart failure, a disease where the heart cannot function sufficiently. To do this, the investigators will use a smartwatch that can measure multiple signals like the participant's heart rate and movement. Investigators will ask participants with and without heart failure to wear the Watch HOP (from HOP-Child Technologies Inc.) and sensors during physical tasks at their clinic visit at the McGill University Health Centre. Researchers will also record the participants' voices between their visits. The key signals can help find who is at risk for heart failure or develop new ways to monitor and treat it.
Read the detailed description
Heart Failure (HF) is a multi-faceted and life-threatening syndrome characterized by significant morbidity and mortality, poor functional capacity and quality of life, and high costs. Logistic and economic difficulties prove screening for HF challenging for some populations, such as people with reduced mobility and the elderly. Sensor technologies and data processing algorithms, including artificial intelligence, represent an opportunity to systematically identify patients suffering from HF as a complementary tool for echocardiography. The ability to compute digital biomarkers using complex models from wearable data requires identifying the key parameters that are associated with the presence of HF. A multisensorial wearable device can be utilized to develop digital biomarkers for population-based screening of HF. The present study aims to evaluate the best signals from a wearable device to identify digital signals (aka digital biomarkers) that are most associated with HF, including all ejection fraction types.
For this study, investigators will recruit 27 participants with HF and 27 without HF. The primary objective of this study is to analyze the key physiological parameters recorded from the platform devices that can develop a digital biomarker for the presence of prevalent HF and its markers like NTproBNP, KCCQ, and 6MWD
- Conditions
- Heart Failure
- Being tested
- Watch HOP
- Keywords
- Wearable, Digital biomarker, Heart rate variability, 6-minute walking test, Voice biomarker
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watch HOPDevice
A multisensorial wearable smartwatch that measures actigraphy (motion), skin temperature, heart rate variability (PPG), electrodermal activity, and voice (via App)
| Study group | Role | What they receive |
|---|---|---|
| Case group (HF) | 1. Clinical signs and/or symptoms of heart failure caused by a structural and/or functional cardiac abnormality, as defined by Bozkurt et al. [2021], diagnosed at the cardiovascular clinic
2. NT-proBNP levels > 125 pg/L or objective evidence of cardiogenic pulmonary or systemic congestion
3. One of the following;
i. For HFpEF, LVEF ≥ 50% ii. For HFmrEF, LVEF 41-49% iii. For HFrEF, LVEF ≤ 40% Receives: Device: Watch HOP | |
| Control group (non-HF) | 1. Absence of known clinical heart failure history.
2. Absence of criteria in the case group. Receives: Device: Watch HOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of heart failure
the diagnosis of heart failure in the clinic based on the Canadian Heart Failure Society guidelines
Measured: baseline
Secondary outcomes (5)
Natriuretic peptide (NT-proBNP) level
A hormone molecule that plays a crucial role in the regulation of the cardiovascular system, used as a biomarker for heart failure.
Measured: baseline and at follow-up (up to 6 months after)
6-minute walking distance (6MWD)
Distance measured during the standardized 6-minute walking test (6MWT) while the participant walks between 2 cones around 30 meters apart, measured by the coordinator with the count of complete and incomplete laps.
Measured: baseline and at follow-up (up to 6 months after)
Kansas City Cardiomyopathy Questionnaire Score (KCCQ)
24-item multiple domain cardiomyopathy questionnaire, validated in the heart failure cohort to assess self-perceived symptoms and their effect on the participant's daily tasks.
Measured: baseline and at follow-up (up to 6 months after)
One-minute sit-to-stand repetitions
Amount of complete sit-to-stand repetitions during the 1MSTS test
Measured: baseline and at follow-up (up to 6 months after)
Left Ventricular Ejection Fraction (LVEF)
the ratio of stroke volume to left ventricular end-diastolic volume
Measured: baseline and at follow-up (up to 6 months after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start15 Jan 2024
- Primary completion29 Jul 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- HOP-Child Technologies Inc
- Responsible party
- Principal investigator, Abhinav Sharma, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Abhinav Sharma, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335264
- Sponsor's protocol ID
- 2024-9987
- Acronym
- WEAR-HF
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Heart Failure Using a Multimodal Wearable Device
- ClinicalTrials.gov ID
- NCT06335264
- Acronym / sponsor ID
- WEAR-HF / 2024-9987
- Conditions
- Heart Failure
- Keywords
- Wearable, Digital biomarker, Heart rate variability, 6-minute walking test, Voice biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- HOP-Child Technologies Inc
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 28 Mar 2024 (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 purpose of this study is to find out if there are any patterns in the way people's bodies react to physical activities and their voices when they have heart failure, a disease where the heart cannot function sufficiently. To do this, the investigators will use a smartwatch that can measure multiple signals like the participant's heart rate and movement. Investigators will ask participants with and without heart failure to wear the Watch HOP (from HOP-Child Technologies Inc.) and sensors during physical tasks at their clinic visit at the McGill University Health Centre. Researchers will also record the participants' voices between their visits. The key signals can help find who is at risk for heart failure or develop new ways to monitor and treat it.
Detailed description
Heart Failure (HF) is a multi-faceted and life-threatening syndrome characterized by significant morbidity and mortality, poor functional capacity and quality of life, and high costs. Logistic and economic difficulties prove screening for HF challenging for some populations, such as people with reduced mobility and the elderly. Sensor technologies and data processing algorithms, including artificial intelligence, represent an opportunity to systematically identify patients suffering from HF as a complementary tool for echocardiography. The ability to compute digital biomarkers using complex models from wearable data requires identifying the key parameters that are associated with the presence of HF. A multisensorial wearable device can be utilized to develop digital biomarkers for population-based screening of HF. The present study aims to evaluate the best signals from a wearable device to identify digital signals (aka digital biomarkers) that are most associated with HF, including all ejection fraction types.
For this study, investigators will recruit 27 participants with HF and 27 without HF. The primary objective of this study is to analyze the key physiological parameters recorded from the platform devices that can develop a digital biomarker for the presence of prevalent HF and its markers like NTproBNP, KCCQ, and 6MWD
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group (HF) | – | Device: Watch HOP1. Clinical signs and/or symptoms of heart failure caused by a structural and/or functional cardiac abnormality, as defined by Bozkurt et al. [2021], diagnosed at the cardiovascular clinic 2. NT-proBNP levels > 125 pg/L or objective evidence of cardiogenic pulmonary or systemic congestion 3. One of the following; i. For HFpEF, LVEF ≥ 50% ii. For HFmrEF, LVEF 41-49% iii. For HFrEF, LVEF ≤ 40% |
| Control group (non-HF) | – | Device: Watch HOP1. Absence of known clinical heart failure history. 2. Absence of criteria in the case group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Case group will be enrolled from the cardiology clinics at the Royal Victoria Hospital (located at MUHC). Patients will be screened for on the clinic lists on a daily basis. The attending physician will be asked if the patient is suitable for enrollment. The participant will be approached, and the informed consent will be taken before enrollment. 2. Control group will be recruited from both the cardiology clinics (patients without heart failure) and Cortois Cardiovascular Signature Program, also at the Royal Victoria Hospital. Patients will be screened for on the clinic lists on a daily basis. The attending physician will be asked if the patient is suitable for enrollment. The participant will be approached, and the informed consent will be taken before enrollment.
Key inclusion criteria (10 listed)
- Able to follow up with the study protocol schedule
- Life expectancy > 1 year
- Case group only
- Control group only
Key exclusion criteria (6 listed)
- Any person who does not meet the above criteria or who refuses to participate
- Undergoing chemotherapy or dialysis
- In addition, the following list of criteria are specific to accurate wrist wearable measurements:
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 |
|---|---|---|
| Watch HOPA multisensorial wearable smartwatch that measures actigraphy (motion), skin temperature, heart rate variability (PPG), electrodermal activity, and voice (via App) | Device | Case group (HF), Control group (non-HF) |
Primary outcome
Presence or absence of heart failure
Time frame: baseline
the diagnosis of heart failure in the clinic based on the Canadian Heart Failure Society guidelines
5 secondary outcomes
Natriuretic peptide (NT-proBNP) level
Time frame: baseline and at follow-up (up to 6 months after)
6-minute walking distance (6MWD)
Time frame: baseline and at follow-up (up to 6 months after)
Kansas City Cardiomyopathy Questionnaire Score (KCCQ)
Time frame: baseline and at follow-up (up to 6 months after)
One-minute sit-to-stand repetitions
Time frame: baseline and at follow-up (up to 6 months after)
Left Ventricular Ejection Fraction (LVEF)
Time frame: baseline and at follow-up (up to 6 months after)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- 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.
Abhinav Sharma, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 6 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: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of heart failure (time frame: baseline). 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 16 Oct 2026.