E_Stethoscope: Portable Digital Auscultation Study on Hypertensive/Hypertensive Heart Disease Patients
NCT ID: NCT02809040
Last Updated: 2017-07-14
Study Results
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Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2015-02-28
2018-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hypertensive Heart Disease
Portable Digital Auscultation/ Electrocardiogram/Echocardiography/ Traditional Stethoscope
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
Volunteer subjects
Portable Digital Auscultation/ Electrocardiogram/Echocardiography/ Traditional Stethoscope
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
Diagnosed Hypertension
Portable Digital Auscultation/ Electrocardiogram/Echocardiography/ Traditional Stethoscope
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
2. Participants with significance valve disease.
1. Strictly exclude hypertensive for Normal healthy volunteers.
2. Not on any anti-hypertensive agents.
21 Years
99 Years
ALL
Yes
Sponsors
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National Heart Centre Singapore
OTHER
Responsible Party
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Principal Investigators
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A/Prof Tan Ru San
Role: PRINCIPAL_INVESTIGATOR
National Heart Centre Singapore
Locations
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National Heart Centre Singapore
Singapore, , Singapore
Countries
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References
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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. doi: 10.1097/00004872-200311000-00002.
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.
Diamond JA, Phillips RA. Hypertensive heart disease. Hypertens Res. 2005 Mar;28(3):191-202. doi: 10.1291/hypres.28.191.
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. doi: 10.1161/hy1101.099484.
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. doi: 10.1056/NEJM199005313222203.
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. doi: 10.1016/j.jacc.2003.11.064.
Lorell BH, Carabello BA. Left ventricular hypertrophy: pathogenesis, detection, and prognosis. Circulation. 2000 Jul 25;102(4):470-9. doi: 10.1161/01.cir.102.4.470. No abstract available.
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. doi: 10.1001/archinte.166.6.617.
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.
Other Identifiers
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2014/2083
Identifier Type: -
Identifier Source: org_study_id
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