Heart Failure Clinical Trial
— WEAR-HFOfficial title:
Screening for Heart Failure Using a Multimodal Wearable Device
NCT number | NCT06335264 |
Other study ID # | 2024-9987 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 15, 2024 |
Est. completion date | December 2024 |
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.
Status | Recruiting |
Enrollment | 54 |
Est. completion date | December 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Able to follow up with the study protocol schedule 2. Life expectancy > 1 year 3. Case group only 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% 4. Control group only 1. Absence of known clinical heart failure history. 2. Absence of criteria above in the case group. Exclusion Criteria: 1. Any person who does not meet the above criteria or who refuses to participate 2. Undergoing chemotherapy or dialysis 3. In addition, the following list of criteria are specific to accurate wrist wearable measurements: 1. Skin burns or rashes on the measurement locations (wrist for wearable, finger for oximeter, chest for Polar ECG) 2. Patients with tremors 3. Recent use of dermatological creams, ointments, or lotions at the recording area |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Centre | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre | HOP-Child Technologies Inc |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence or absence of heart failure | the diagnosis of heart failure in the clinic based on the Canadian Heart Failure Society guidelines | up to 3 months, between two clinical visits | |
Secondary | left ventricular ejection fraction (LVEF) | The classification of HF includes HF with reduced ejection fraction (HFrEF): HF with LVEF =40%; HF with mildly reduced ejection fraction (HFmrEF): HF with LVEF 41-49%; HF with preserved ejection fraction (HFpEF): HF with LVEF =50%; and HF with improved ejection fraction (HFimpEF): HF with a baseline LVEF =40%, a =10 point increase from baseline LVEF, and a second measurement of LVEF >40%. | up to 3 months, between two clinical visits | |
Secondary | 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. | up to 3 months, between two clinical visits |
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