Screening of Diastolic Dysfunction With Impedance Cardiography in Hypertensive Patients

NCT03209141 | Completed

• 1 other identifier: CHLC.CI.165.2013
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 3

Brief Summary

Arterial hypertension (AHT) is responsible for important morbidity and mortality. The cardiac repercussion of AHT is usually assessed by electrocardiography and echocardiography, time-consuming, technically demanding examinations that require experienced operators, which limits their use for screening diastolic dysfunction. Alternative tools for the screening of diastolic function in hypertensive patients are needed. Impedance cardiography (IC) is presently used in the study of AHT and in the optimization of antihypertensive therapy. It seems an attractive and economical option to change the clinical approach for screening; however, its validation in well-defined populations is required to sustain its use in clinical practice. The IMPEDDANS study aims to validate IC for screening left ventricular diastolic dysfunction in outclinic patients with AHT, using functional echocardiography as the clinical standard. Descriptive and analytical study with analysis of the agreement between the diagnosis of diastolic dysfunction and its degree, as well as the parameters obtained by impedance cardiography and echocardiography in patients with AHT.

Conditions

Hypertension; Diastolic Dysfunction

Keywords

hypertension; Diastolic Dysfunction; impedance cardiography; echocardiography

Outcome Measures

Primary Outcomes (2)

• Predictive value of impedance cardiography to identify diastolic dysfunction

  Positive predictive value of impedance cardiography to identify diastolic dysfunction, compared with echocardiography

  Less than 10 days between measurements

• Area under the curve (AUC)

  The area under the receiver-operator curves (ROC) for identification of diastolic dysfunction by impedance cardiography, compared with echocardiography

  Less than 10 days between measurements

Secondary Outcomes (1)

• Negative predictive value of impedance cardiography to identify diastolic dysfunction

  Less than 10 days between measurements

Study Arms (2)

Diastolic dysfunctional hypertension

Patients with confirmed arterial hypertension and diastolic dysfunction by echocardiographic diastolic function evaluation

Diagnostic Test: Diastolic function evaluation

Non diastolic dysfunctional hypertension

Patients with confirmed arterial hypertension and without diastolic dysfunction by echocardiographic diastolic function evaluation

Diagnostic Test: Diastolic function evaluation

Interventions

Diastolic function evaluation DIAGNOSTIC_TEST

Diastolic function assessed by impedance cardiography (test to be validated) is compared with the assessment by echocardiography (clinical standard)

Diastolic dysfunctional hypertension; Non diastolic dysfunctional hypertension

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with arterial hypertension attending the outpatient clinic consultation

You may qualify if:

• grade 2 or 3 hypertension (systolic blood pressure ≥ 160 mmHg and/or with diastolic blood pressure values ≥ 100 mmHg) and/or with resistant hypertension (as defined by European Society of Cardiology

You may not qualify if:

• pregnancy,
• height less than 120 cm or more than 230 cm,
• weight less than 30 kg or greater than 155 kg,
• heart failure II-IV NYHA,
• heart rate (HR) less than 50 bpm or greater than 110 bpm,
• atrial fibrillation or flutter,
• \> 3 premature ventricular contractions per hour,
• complete left bundle branch or atrioventricular block,
• severe valvulopathies,
• constrictive pericarditis,
• hypertrophic and restrictive cardiomyopathy,
• prior history of ischemic heart disease and/or segmental kinetics alterations assessed by echocardiography,
• left ejection fraction \< 50%,
• poor echocardiographic window ,
• pacemaker.

Sponsors & Collaborators

• Centro Hospitalar de Lisboa Central: lead

Study Sites (3)

Consulta de Hipertensão Arterial, UF Medicina 1.4 do Hospital São José, Centro Hospitalar de Lisboa Central

Lisbon, 1150-199, Portugal

Location

Consulta de Risco Vascular da Unidade Funcional Medicina 1.2, Hospital São José, Centro Hospitalar de Lisboa Central

Lisbon, 1150-199, Portugal

Location

Núcleo de Hipertensão Arterial, Consulta de Medicina do Hospital de Santa Marta, Centro Hospitalar de Lisboa Central

Lisbon, 1169-024, Portugal

Location

Related Publications (20)

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• Nazario Leao R, Marques da Silva P. Diastolic dysfunction in hypertension. Hipertens Riesgo Vasc. 2017 Jul-Sep;34(3):128-139. doi: 10.1016/j.hipert.2017.01.001. Epub 2017 Mar 6.

  PMID: 28268171 BACKGROUND

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  PMID: 23558598 BACKGROUND

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• Nagueh SF, Appleton CP, Gillebert TC, Marino PN, Oh JK, Smiseth OA, Waggoner AD, Flachskampf FA, Pellikka PA, Evangelisa A. Recommendations for the evaluation of left ventricular diastolic function by echocardiography. Eur J Echocardiogr. 2009 Mar;10(2):165-93. doi: 10.1093/ejechocard/jep007. No abstract available.

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• Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014.

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• DeMarzo AP. Using impedance cardiography with postural change to stratify patients with hypertension. Ther Adv Cardiovasc Dis. 2011 Jun;5(3):139-48. doi: 10.1177/1753944711406770. Epub 2011 Apr 28.

  PMID: 21527444 BACKGROUND

• Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.

  PMID: 23817082 BACKGROUND

• Nazario Leao R, Marques Silva P, Branco L, Fonseca H, Bento B, Alves M, Virella D, Palma Reis R. Systolic time ratio measured by impedance cardiography accurately screens left ventricular diastolic dysfunction in patients with arterial hypertension. Clin Hypertens. 2017 Dec 27;23:28. doi: 10.1186/s40885-017-0084-y. eCollection 2017.

  PMID: 29299336 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rodrigo N Leão, MD

  Centro Hospitalar de Lisboa Central

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 6, 2017
• Study Start: January 2, 2015
• Primary Completion: September 30, 2017
• Study Completion: January 15, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (3)