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Non-invasive Diagnosis of Pulmonary Hypertension by Impedance Cardiography

NCT ID: NCT03876509

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-04

Study Completion Date

2020-06-30

Brief Summary

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The goal of the study is to prospectively evaluate Impedance Cardiography as a tool to detect pulmonary hypertension. According to our hypothesis Impedance Cardiography is a valuable method to differentiate patients without pulmonary hypertension from patients with pulmonary hypertension. The main objective is to determine the sensitivity and specificity in comparison to the gold standard right heart catheterization.

Detailed Description

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Conditions

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Pulmonary Hypertension

Keywords

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impedance cardiography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Impedance Cardiography

Impedance Cardiography

Impedance Cardiography

Intervention Type DIAGNOSTIC_TEST

Impedance Cardiography will be conducted in patients with suspected Pulmonary Hypertension within an interval of 24 hours to right-heart catheterization. Usually, 8 electrodes will be attached on the neck and thorax of the patient. These electrodes will produce current (max 400µA) and measure the voltage which is produced by the current running through the body. The Signal will be analyzed for specific signs of Pulmonary Hypertension.

At the same time electrocardiography and non-invasive continuous blood pressure will be measured.

Interventions

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Impedance Cardiography

Impedance Cardiography will be conducted in patients with suspected Pulmonary Hypertension within an interval of 24 hours to right-heart catheterization. Usually, 8 electrodes will be attached on the neck and thorax of the patient. These electrodes will produce current (max 400µA) and measure the voltage which is produced by the current running through the body. The Signal will be analyzed for specific signs of Pulmonary Hypertension.

At the same time electrocardiography and non-invasive continuous blood pressure will be measured.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Written Informed Consent
* Patients with clinical indication for right heart catheterization

Exclusion Criteria

* known Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Horst Olschewski, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University Graz, Division of Pulmonology

Graz, Styria, Austria

Site Status

Countries

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Austria

Other Identifiers

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29-478 ex 16/17

Identifier Type: -

Identifier Source: org_study_id