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Screening of Diastolic Dysfunction With Impedance Cardiography in Hypertensive Patients (IMPEDDANS)

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ClinicalTrials.gov Identifier: NCT03209141
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Centro Hospitalar de Lisboa Central

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.

Condition or disease Intervention/treatment
Hypertension Diastolic Dysfunction Diagnostic Test: Diastolic function evaluation

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Study Type : Observational
Actual Enrollment : 154 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Impedance Cardiography in the Evaluation of Left Ventricular Diastolic Dysfunction in Patients With Arterial Hypertension Study (IMPEDDANS)
Actual Study Start Date : January 2, 2015
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : January 15, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Diastolic dysfunctional hypertension
Patients with confirmed arterial hypertension and diastolic dysfunction by echocardiographic diastolic function evaluation
Diagnostic Test: Diastolic function evaluation
Diastolic function assessed by impedance cardiography (test to be validated) is compared with the assessment by echocardiography (clinical standard)

Non diastolic dysfunctional hypertension
Patients with confirmed arterial hypertension and without diastolic dysfunction by echocardiographic diastolic function evaluation
Diagnostic Test: Diastolic function evaluation
Diastolic function assessed by impedance cardiography (test to be validated) is compared with the assessment by echocardiography (clinical standard)




Primary Outcome Measures :
  1. Predictive value of impedance cardiography to identify diastolic dysfunction [ Time Frame: Less than 10 days between measurements ]
    Positive predictive value of impedance cardiography to identify diastolic dysfunction, compared with echocardiography

  2. Area under the curve (AUC) [ Time Frame: Less than 10 days between measurements ]
    The area under the receiver-operator curves (ROC) for identification of diastolic dysfunction by impedance cardiography, compared with echocardiography


Secondary Outcome Measures :
  1. Negative predictive value of impedance cardiography to identify diastolic dysfunction [ Time Frame: Less than 10 days between measurements ]
    Negative predictive value of impedance cardiography to identify diastolic dysfunction, compared with echocardiography



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with arterial hypertension attending the outpatient clinic consultation
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209141


Locations
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Portugal
Consulta de Hipertensão Arterial, UF Medicina 1.4 do Hospital São José, Centro Hospitalar de Lisboa Central
Lisboa, Portugal, 1150-199
Consulta de Risco Vascular da Unidade Funcional Medicina 1.2, Hospital São José, Centro Hospitalar de Lisboa Central
Lisboa, Portugal, 1150-199
Núcleo de Hipertensão Arterial, Consulta de Medicina do Hospital de Santa Marta, Centro Hospitalar de Lisboa Central
Lisboa, Portugal, 1169-024
Sponsors and Collaborators
Centro Hospitalar de Lisboa Central
Investigators
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Principal Investigator: Rodrigo N Leão, MD Centro Hospitalar de Lisboa Central
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centro Hospitalar de Lisboa Central
ClinicalTrials.gov Identifier: NCT03209141    
Other Study ID Numbers: CHLC.CI.165.2013
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centro Hospitalar de Lisboa Central:
hypertension
Diastolic Dysfunction
impedance cardiography
echocardiography
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases