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

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 |

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

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
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 |
Principal Investigator: | Rodrigo N Leão, MD | Centro Hospitalar de Lisboa Central |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
hypertension Diastolic Dysfunction impedance cardiography echocardiography |
Hypertension Vascular Diseases Cardiovascular Diseases |