Screening for Heart Failure Using a Multimodal Wearable Device

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT06335264
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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. 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.

Study Timeline

• Study Start: 2024-01-15
• Status Verified: 2024-03
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-28
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-07
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence or absence of heart failure	up to 3 months, between two clinical visits	the diagnosis of heart failure in the clinic based on the Canadian Heart Failure Society guidelines

Secondary Outcome Measures

Name	Time	Method
Natriuretic peptide (NT-proBNP) level	up to 3 months, between two clinical visits	A hormone molecule that plays a crucial role in the regulation of the cardiovascular system, used as a biomarker for heart failure.
left ventricular ejection fraction (LVEF)	up to 3 months, between two clinical visits	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%.

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada