Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance Trial

NCT06671171 | Completed FDA Device

• 2 other identifiers: WATCH-XHKU / HA HKW IRB
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 involving 50-100 participants that aims to validate smartwatchbased 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, the investigators seek to determine the reliability and potential clinical utility of these wearable devices in diverse cardiovascular contexts. This research will help bridge the gap between consumer-grade wearable technology and clinical practice in cardiology.

Conditions

Congenital Heart Disease; Pulmonary Hypertension; Heart Failure; Coronary Artery Disease

Keywords

congenital heart disease; pulmonary hypertension; heart failure; coronary artery disease; athletes; smartwatch

Outcome Measures

Primary Outcomes (1)

• Correlation between CPX VO2max and smartwatch parameters (virtual VO2 max, physical activity parameters)

  VO2 max (ml/min/kg) concurrently measured with a medical-grade device and a smartwatch which has virutal VO2 max and physical activity parameters as assessed during treadmill exercise

  During treadmill exercise in the day of recruitment and concurrently baseline assessment (Visit 1/ Week 1)

Secondary Outcomes (5)

• Correlation between VO2 max (ml/min/kg) obtained using medical-grade device and smartwatch

  From enrollment to end of follow up at Visit 2(Week 2)

• Correlation between SaO2 (%) obtained using medical-grade device and smartwatch

  From enrollment to end of follow up at Visit 2(Week 2)

• SaO2 (%) measured by the smartwatch

  From enrollment to end of follow up at Visit 2(Week 2)

• SaO2 (%) in participants with severe disease and participants with mild disease

  From enrollment to end of follow up at Visit 2(Week 2)

• Novel markers or patterns

  From enrollment to end of follow up at Visit 2(Week 2)

Study Arms (1)

WatchX

Participants will wear the investigational smartwatch (Apple Watch Series 9) concurrently for pre- and post-SaO2 and VO2max assessment during cardiopulmonary exercise test at Visit 1. Through one-week study period, participants will record their oxygen saturation data collected by the smartwatch once daily in a provided log, preferably in the morning after waking and before any strenuous activity. At Visit 2, participants will walk for a 6-Minute walk test and wear the investigational smartwatch (Apple Watch Series 9) concurrently for pre- and post-SaO2 and VO2max assessment during assessment.

Device: Apple Watch Series 9

Interventions

Apple Watch Series 9 DEVICE

Participants will wear Apple Watch Series 9 during cardiopulmonary exercise test (in Visit 1), 1-week study period and 6-Minute walk distance test (in Visit 2) to have assessment of maximal oxygen uptake and pre- and post-SaO2. During 1-week study period, participants will measure their oxygen saturation once daily with a medical-grade pulse oximeter while wearing the smartwatch continuously.

WatchX

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with congenital heart disease, pulmonary hypertension, heart failure, and coronary artery disease, as well as athletes undergoing cardiovascular assessment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Medicine Queen Marry Hospital

Hong Kong, Hong Kong

Location

Related Publications (6)

• Guo Y, Wang H, Zhang H, Liu T, Liang Z, Xia Y, Yan L, Xing Y, Shi H, Li S, Liu Y, Liu F, Feng M, Chen Y, Lip GYH; MAFA II Investigators. Mobile Photoplethysmographic Technology to Detect Atrial Fibrillation. J Am Coll Cardiol. 2019 Nov 12;74(19):2365-2375. doi: 10.1016/j.jacc.2019.08.019. Epub 2019 Sep 2.

  PMID: 31487545 RESULT

• Chan PH, Wong CK, Poh YC, Pun L, Leung WW, Wong YF, Wong MM, Poh MZ, Chu DW, Siu CW. Diagnostic Performance of a Smartphone-Based Photoplethysmographic Application for Atrial Fibrillation Screening in a Primary Care Setting. J Am Heart Assoc. 2016 Jul 21;5(7):e003428. doi: 10.1161/JAHA.116.003428.

  PMID: 27444506 RESULT

• Wong CK, Lau YM, Lui HW, Chan WF, San WC, Zhou M, Cheng Y, Huang D, Lai WH, Lau YM, Siu CW. Automatic detection of cardiac conditions from photos of electrocardiogram captured by smartphones. Heart. 2024 Aug 14;110(17):1074-1082. doi: 10.1136/heartjnl-2023-323822.

  PMID: 38768982 RESULT

• Mannhart D, Lischer M, Knecht S, du Fay de Lavallaz J, Strebel I, Serban T, Vogeli D, Schaer B, Osswald S, Mueller C, Kuhne M, Sticherling C, Badertscher P. Clinical Validation of 5 Direct-to-Consumer Wearable Smart Devices to Detect Atrial Fibrillation: BASEL Wearable Study. JACC Clin Electrophysiol. 2023 Feb;9(2):232-242. doi: 10.1016/j.jacep.2022.09.011. Epub 2023 Jan 18.

  PMID: 36858690 RESULT

• Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.

  PMID: 31722151 RESULT

• Wong CK, Un KC, Zhou M, Cheng Y, Lau YM, Shea PC, Lui HW, Zuo ML, Yin LX, Chan EW, Wong ICK, Sin SWC, Yeung PPN, Chen H, Wibowo S, Wei TLN, Lee SM, Chow A, Tong RCF, Hai J, Tam FCC, Siu CW. Daily ambulatory remote monitoring system for drug escalation in chronic heart failure with reduced ejection fraction: pilot phase of DAVID-HF study. Eur Heart J Digit Health. 2022 May 7;3(2):284-295. doi: 10.1093/ehjdh/ztac024. eCollection 2022 Jun.

  PMID: 36713022 RESULT

MeSH Terms

Conditions

Heart Defects, Congenital; Hypertension, Pulmonary; Heart Failure; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: November 4, 2024
• Study Start: February 3, 2025
• Primary Completion: February 23, 2026
• Study Completion: March 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

HK (1)