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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02809040
• Other study ID #: 2014/2083
• Status: Active, not recruiting
• Phase: N/A
• First received: May 31, 2016
• Last updated: July 11, 2017
• Start date: February 2015
• Est. completion date: May 2018

Study information

• Verified date: July 2017
• Source: National Heart Centre Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 .

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Diseases
• Hypertension
• Hypertensive Heart Disease

Intervention

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.
• 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

Locations

Country	Name	City	State
Singapore	National Heart Centre Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Heart Centre Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (9)

Diamond JA, Phillips RA. Hypertensive heart disease. Hypertens Res. 2005 Mar;28(3):191-202. Review. — View Citation

Drazner MH, Rame JE, Marino EK, Gottdiener JS, Kitzman DW, Gardin JM, Manolio TA, Dries DL, Siscovick DS. Increased left ventricular mass is a risk factor for the development of a depressed left ventricular ejection fraction within five years: the Cardiovascular Health Study. J Am Coll Cardiol. 2004 Jun 16;43(12):2207-15. — View Citation

James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427. Erratum in: JAMA. 2014 May 7;311(17):1809. — View Citation

Levy D, Garrison RJ, Savage DD, Kannel WB, Castelli WP. Prognostic implications of echocardiographically determined left ventricular mass in the Framingham Heart Study. N Engl J Med. 1990 May 31;322(22):1561-6. — View Citation

Lorell BH, Carabello BA. Left ventricular hypertrophy: pathogenesis, detection, and prognosis. Circulation. 2000 Jul 25;102(4):470-9. Review. — View Citation

Marcus GM, Vessey J, Jordan MV, Huddleston M, McKeown B, Gerber IL, Foster E, Chatterjee K, McCulloch CE, Michaels AD. Relationship between accurate auscultation of a clinically useful third heart sound and level of experience. Arch Intern Med. 2006 Mar 27;166(6):617-22. Erratum in: Arch Intern Med. 2006 Jun 12;166(11):1217. Marcus, Gregory [corrected to Marcus, Gregory M]. — View Citation

Shah SJ, Nakamura K, Marcus GM, Gerber IL, McKeown BH, Jordan MV, Huddleston M, Foster E, Michaels AD. Association of the fourth heart sound with increased left ventricular end-diastolic stiffness. J Card Fail. 2008 Jun;14(5):431-6. doi: 10.1016/j.cardfail.2008.01.010. Epub 2008 May 27. — View Citation

Whitworth JA; World Health Organization, International Society of Hypertension Writing Group. 2003 World Health Organization (WHO)/International Society of Hypertension (ISH) statement on management of hypertension. J Hypertens. 2003 Nov;21(11):1983-92. — View Citation

Zannad F, Dousset B, Alla F. Treatment of congestive heart failure: interfering the aldosterone-cardiac extracellular matrix relationship. Hypertension. 2001 Nov;38(5):1227-32. Review. — View Citation

Outcome

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