Pulse Signal Acquisition in Patients With Heart Failure (TCM PA)

Singapore Health Services (SingHealth)

Status: Active, not recruiting

Conditions: Heart Failure

Treatments: Device: Pulse Measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT07376993

MOE-MOE2020-TIF-0005 (Other Grant/Funding Number)

2022-2338

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Intervention

Experimental group

Description:

Pulse signal measurement using measurement device

Treatment:

Device: Pulse Measurement