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Not Yet Recruiting NCT07663799

Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance Trial Prospective

Conditions: Congenital Heart Disease, Pulmonary Hypertension, Heart Failure, Coronary Heart Disease (CHD), Apple Watch

Sex: All
Ages: 20 Years – 70 Years
Healthy volunteers: No
Enrollment: 20
Sponsor: The University of Hong Kong

Location: Department of Medicine, Queen Mary Hospital Hong Kong

Summary

Wearable health technology, particularly smartwatches, has revolutionized personal health monitoring by enabling continuous, non-invasive tracking of various physiological parameters. The potential applications of these devices in cardiology are extensive, but it is crucial to validate their accuracy against established medical-grade devices. The Apple Watch Series 9 (Apple, USA) exemplifies the capabilities of modern smartwatches, offering a wide range of health tracking features. These include heart rate monitoring, detection of irregular heart rhythms suggestive of atrial fibrillation, electrocardiogram recording, blood oxygen level measurement, and comprehensive mobility metrics (including VO2 max, six-minute walk distance, walking speed, step length, double support time, and walking asymmetry). Many of these parameters are highly relevant for cardiovascular patients, potentially aiding in disease progression monitoring and adverse event prediction. However, there is a lack of comprehensive validation studies for these devices in specific cardiovascular disease populations. This investigator-initiated, prospective observational study will consist of two phases: a training phase which involves 50 participants and a prospective validation phase which involves 20 participants. The study aims to validate smartwatch-based assessments using medical-grade devices and techniques. The study will focus on adult patients with congenital heart disease, pulmonary hypertension, heart failure, and coronary artery disease, as well as athletes undergoing cardiovascular assessment. By comparing smartwatch data with established clinical measurements, we seek to determine the reliability and potential clinical utility of these wearable devices in diverse cardiovascular contexts. Anonymized smartwatch data collected during the two phases will be published to a publicly registry to facilitate further research. This research will help bridge the gap between consumer-grade wearable technology and clinical practice in cardiology.

Eligibility Criteria

Inclusion Criteria: * Age 20 to 70 years old * Ability to provide informed consent * History of the following cardiovascular conditions: * Adult congenital heart disease * Pulmonary hypertension * Heart failure * Coronary artery disease * Athletes undergoing cardiovascular assessment Exclusion Criteria: * Contraindication for undergoing physical exertion including cardio-pulmonary exercise testing (CPX) and 6-minute walk test (6MWT) * Pregnancy * Known allergy to components of the investigational product

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07663799). StuddyBuddy aggregates publicly available trial information.