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Pulse Signal Acquisition in Patients With Heart Failure

Pulse Signal Acquisition in Patients With Heart Failure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07376993
Acronym
TCM PA
Enrollment
60
Registered
2026-01-29
Start date
2023-04-12
Completion date
2030-12-31
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

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.

Interventions

DEVICEPulse Measurement

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.

Sponsors

National Heart Centre Singapore
Lead SponsorOTHER
Temasek Polytechnic, Singapore
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
AI-developed Heart Failure detection algorithmOn the day of enrollmentTo develop pulse pattern feature extraction, selection, and classification models using AI approaches with a premier focus on HF detection, based on TCM theory.
Pulse data acquisition from HF patients and non-HF peopleOn the day of enrollmentTo collect pulse data from HF patients and non-HF people to train and test the machine learning models developed based on AI methods.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026