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

NCT02809040 | Unknown

• 1 other identifier: 2014/2083
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Hypertension; Hypertensive Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

Hypertensive Heart Disease

Portable Digital Auscultation/ Electrocardiogram/Echocardiography/ Traditional Stethoscope

Other: Electrocardiogram/Echocardiography; Other: Portable digital auscultation

Volunteer subjects

Portable Digital Auscultation/ Electrocardiogram/Echocardiography/ Traditional Stethoscope

Other: Electrocardiogram/Echocardiography; Other: Portable digital auscultation

Diagnosed Hypertension

Portable Digital Auscultation/ Electrocardiogram/Echocardiography/ Traditional Stethoscope

Other: Electrocardiogram/Echocardiography; Other: Portable digital auscultation

Interventions

Electrocardiogram/Echocardiography OTHER

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.

Diagnosed Hypertension; Hypertensive Heart Disease; Volunteer subjects

Portable digital auscultation OTHER

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; Hypertensive Heart Disease; Volunteer subjects

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Participants with clinically suspected or known HT/Hypertensive Heart Disease who have been scheduled for echocardiography examination and/or cardiac catheterization.
• Participants with history of high BP and stable medication for at least 2 weeks.
• Presence of the following :
• Elevated BP measurement or Left ventricular hypertrophy (LVH) on either prior ECG or prior echo.

You may not qualify if:

• Participants with heart muscle disease.
• Participants with significance valve disease.
• Strictly exclude hypertensive for Normal healthy volunteers.
• Not on any anti-hypertensive agents.

Sponsors & Collaborators

• National Heart Centre Singapore: lead

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

Related Publications (9)

• 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.

  PMID: 14597836 BACKGROUND

• 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.

  PMID: 24352797 BACKGROUND

• Diamond JA, Phillips RA. Hypertensive heart disease. Hypertens Res. 2005 Mar;28(3):191-202. doi: 10.1291/hypres.28.191.

  PMID: 16097361 BACKGROUND

• 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.

  PMID: 11711528 BACKGROUND

• 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.

  PMID: 2139921 BACKGROUND

• 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.

  PMID: 15193681 BACKGROUND

• 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.

  PMID: 10908222 BACKGROUND

• 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.

  PMID: 16567599 BACKGROUND

• 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.

  PMID: 18514937 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• A/Prof Tan Ru San

  National Heart Centre Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 22, 2016
• Study Start: February 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: July 14, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)