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NCT Number: NCT07376993

Pulse Signal Acquisition in Patients With Heart Failure

Heart Failure (HF) is usually a chronic condition that gradually gets worse. The heart muscle becomes weaker and has trouble pumping blood to nourish the cells in human body. General symptoms are breathlessness, fatigue, ankle swelling. Accurate and timely diagnosis is crucial to ensure patients receive appropriate treatment. Patients often present to primary care clinicians, however diagnosis by primary care clinicians is inaccurate as symptoms and signs commonly overlap with other conditions. Only 26% of patients with a suspected HF have a confirmed diagnosis after formal investigation according to diagnostic criteria. There is a strong demand to develop an accurate, easy-to-use, costeffective device to detect HF in primary clinics or even by patients themselves before it is too late to modify the natural history of the disease.

TCM palpation provides a simple, cheap, and non-invasive approach for diagnosis and evaluation of the severity of HF, and does not involve use of expensive equipment. There are several specific pulse patterns associated with the clinical manifestation of HF. One of the project collaborators, a TCM physician with a PhD in Chinese Medicine, explained that patients with HF usually have alternating pulse strengths, strong pulse and subsequent weak pulses. The various degrees of severity can be readily manifested as Jiemai, Cumai, and Daimai on the pulse palpation. Based on the investigators' preliminary sensor test results, these pulse features can be easily detected using a micro tubular epidermal sensor, likewise developed by the investigators. Therefore, the investigators propose to use their micro tubular epidermal sensor to develop a TCM pulse analyser, which can be used by primary care clinicians and patient themselves to detect HF in a timely and accurate manner.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Heart Centre Singapore

Singapore, 169609

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 35 years and above.
  • The recruited patients should have been diagnosed by NHCS's Doctor in charge with HF.
  • Ability to provide informed consent.

Exclusion criteria

  • Pregnant Women as their TCM pulse signal maybe different from normal (non-pregnant) time.

Treatment and study plan

Pulse Measurement

Device

TCM pulse signal data will be collected using project group developed pulse data collector, the collected TCM pulse signal is visible on the collector display screen. Project staff will place the pulse collector cuff on the wrist of the participant. During the process, the airbag in the cuff will be inflated with air several times to press the pressure sensor against participants' wrist and deflated several times to release the pressure. Under different airbag pressure, the TCM pulse signal from different depths (Fu, Zhong, and Chen) against the wrist will be collected. During the test, the project staff will move the cuff along the wrist to collect the TCM pulse signal from different wrist positions (Cun, Guan, and Chi) according to TCM theory.

Primary outcomes

  1. AI-developed Heart Failure detection algorithm

    Time frame: On the day of enrollment

    To develop pulse pattern feature extraction, selection, and classification models using AI approaches with a premier focus on HF detection, based on TCM theory.

  2. Pulse data acquisition from HF patients and non-HF people

    Time frame: On the day of enrollment

    To collect pulse data from HF patients and non-HF people to train and test the machine learning models developed based on AI methods.

Sponsors and collaborators

Lead sponsor

National Heart Centre Singapore

Other

Collaborators

  • Temasek Polytechnic, Singapore

Registry information

Acronym: TCM PA

Important dates

Study start
2023
Primary completion
2023
Study completion
2030
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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