E_Stethoscope: Portable Digital Auscultation Study on Hypertensive/Hypertensive Heart Disease Patients

July 11, 2017 updated by: National Heart Centre Singapore

E_Stethoscope : Portable Digital Auscultation Based on Wireless Sensor Node to Diagnose Diastolic Dysfunction in Hypertensive Heart Disease

Hypertensive heart disease (HHD) is a heart condition that is caused by chronic exposure to high blood pressure. In patients with HHD, abnormalities in the way heart muscle relaxes and how heart chambers passively fill with blood (diastolic dysfunction) can occur that may be detected on echocardiography (echo), which is a standard clinical method to examine heart structure and function using reflected sound waves. Investigators propose to develop a digital auscultation system or electronic stethoscope based on wireless sensor node technique. Investigators hypothesize that the heart sounds measurements detected by electronic stethoscope can be used to detect heart diastolic dysfunction in HHD .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study proposal aims to look into treatment of hypertension (HT) and its complications of the exact high healthcare costs. In 2004, Singapore adult prevalence of hypertension was 20.1%. World Health Organization estimates that HT causes 4.5% of global disease burden, and that 62% of cerebrovascular disease and 49% of ischemic heart disease are attributable to suboptimal blood pressure (BP) control.

Recently, scrutiny has been focused on appropriate BP levels at which to initiate HT treatment with the benefit of strict BP targets in otherwise uncomplicated HT is questioned, as HT drug treatment is not without risks. This underscores the need to stratify hypertension patients according to target organ damage, so that affected HT patients may be selected for intensive BP lowering.

Hypertensive heart disease (HHD) is a heart condition that is caused by chronic exposure to high BP. As population ages, both HT and Hypertensive Heart Disease prevalence increase. Genetic and hemodynamic factors interact to cause Hypertensive Heart Disease in patients with hypertension. In patients with Hypertensive Heart Disease , abnormalities of both myocardial relaxation and passive filling may be detected sometimes on echocardiography (echo). These diastolic dysfunctions are due to various mechanisms but central to the pathophysiology is an increase in myocardial stiffness. Early symptoms of myocardial stiffness caused by left ventricular hypertrophy (LVH) is a good early indicator for cardiovascular target organ damage in patients with HT and Hypertensive Heart Disease . Hypertensive Heart Disease patients constitute a group in which intensive BP treatment with drugs to strict targets are shown to yield favourable benefit risk ratios. As such, the identification of Hypertensive Heart Disease patients becomes paramount.

An electrocardiogram (ECG) monitors and records the heart's electrical activity. ECG is insensitive to detect diastolic dysfunction with sensitivity from 12% to 50%. An echo takes a picture of the heart using ultrasound. Echo can be used to diagnose diastolic function, however, no one single echo parameter can make the diagnosis. Multiple echo parameters have been proposed including mitral inflow velocity pattern, pulmonary vein flow patterns and tissue Doppler measurements, but imprecise. Existing ultrasound scans cost in the range of US$300-$600 which are reimbursable under Medicaid (the payer). A coronary angiography examines the flow of blood through the heart by inserting a catheter into the heart. It is too invasive and too costly. Therefore, there is appealing need to have a cheaper non-invasive solution that would be able to detect diastolic function. That will have largest impact on patients management and on payers.

A cheap, non-invasive and sensitive solution that permits detection via auscultation of abnormal heart sounds, indicating stiff heart muscle associated with Hypertensive Heart Disease among HT patients is critically needed. Cardiac auscultation (listening to heart sounds) is possible option as heart sounds are associated with myocardial function and dysfunction .In a normal heart, two heart sounds (S1 and S2) are audible, corresponding to closure of the mitral and aortic heart valves respectively. A third heart sound S3, occurring after S2 is present in some heart failure. A fourth heart sound S4, occurring just before S1, is due to forceful contraction of the atrium to overcome a stiff or hypertrophic left ventricle . Human ears are not well equipped to detect such abnormities consistently with a conventional stethoscope. Therefore, investigators propose to develop a low power, non-invasive, portable device which is based on Wireless Sensor Node (WSN) technology to achieve our goal of portable auscultation.Proposed device will allow a monitoring/recording of heart sounds in-situ and perform preliminary assessment of diastolic function that is physiologically meaningful, reproducible and validated. Multiple devices can also be placed and used concurrently at different sites over the torso to enhance chances of detecting abnormal heart sounds.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169609
        • National Heart Centre Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from primary care clinic and outpatient clinics from the National Heart Centre Singapore.

Description

Inclusion Criteria:

  1. Participants with clinically suspected or known HT/Hypertensive Heart Disease who have been scheduled for echocardiography examination and/or cardiac catheterization.
  2. Participants with history of high BP and stable medication for at least 2 weeks.
  3. Presence of the following :

Elevated BP measurement or Left ventricular hypertrophy (LVH) on either prior ECG or prior echo.

Exclusion Criteria for patient

  1. Participants with heart muscle disease.
  2. Participants with significance valve disease.

Exclusion Criteria for volunteer:

  1. Strictly exclude hypertensive for Normal healthy volunteers.
  2. Not on any anti-hypertensive agents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hypertensive Heart Disease
Portable Digital Auscultation/ Electrocardiogram/Echocardiography/ Traditional Stethoscope
Other: Electrocardiogram/Echocardiography

Electrocardiogram (ECG) is a non-invasive (does not require an incision into the body) test that records the electrical activity of the heart.

Echocardiography is a non-invasive scanning of heart images using standard two-dimensional, three-dimensional, and Doppler ultrasound to create images of the heart.

Other: Portable digital auscultation

Traditional Stethoscope :An acoustic medical device for auscultation, or listening to internal sounds of human body.

Digital Stethoscope :Electronic stethoscope is a passive heart sound recording device. The heart sound listening and recording will be performed by trained personnel in a way very similar to that of using conventional cardiac auscultation
Volunteer subjects
Portable Digital Auscultation/ Electrocardiogram/Echocardiography/ Traditional Stethoscope
Other: Electrocardiogram/Echocardiography

Electrocardiogram (ECG) is a non-invasive (does not require an incision into the body) test that records the electrical activity of the heart.

Echocardiography is a non-invasive scanning of heart images using standard two-dimensional, three-dimensional, and Doppler ultrasound to create images of the heart.

Other: Portable digital auscultation

Traditional Stethoscope :An acoustic medical device for auscultation, or listening to internal sounds of human body.

Digital Stethoscope :Electronic stethoscope is a passive heart sound recording device. The heart sound listening and recording will be performed by trained personnel in a way very similar to that of using conventional cardiac auscultation
Diagnosed Hypertension
Portable Digital Auscultation/ Electrocardiogram/Echocardiography/ Traditional Stethoscope
Other: Electrocardiogram/Echocardiography

Electrocardiogram (ECG) is a non-invasive (does not require an incision into the body) test that records the electrical activity of the heart.

Echocardiography is a non-invasive scanning of heart images using standard two-dimensional, three-dimensional, and Doppler ultrasound to create images of the heart.

Other: Portable digital auscultation

Traditional Stethoscope :An acoustic medical device for auscultation, or listening to internal sounds of human body.

Digital Stethoscope :Electronic stethoscope is a passive heart sound recording device. The heart sound listening and recording will be performed by trained personnel in a way very similar to that of using conventional cardiac auscultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart sound measurement from proposed device will be correlated with diastolic functional parameters from echo result and cardiac catheterization.
Time Frame: Through study completion (October 2016)
Heart sound measurement will be correlated with End diastolic pressure from cardiac catheterisation.
Through study completion (October 2016)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart Centre Singapore

Investigators

  • Principal Investigator: A/Prof Tan Ru San, National Heart Centre Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

July 14, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/2083

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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