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NCT03876509 Clinical Trial

Non-invasive Diagnosis of Pulmonary Hypertension by Impedance Cardiography

Pulmonary Hypertension Clinical Trial

Official title:
Non-invasive Diagnosis of Pulmonary Hypertension by Thoracic Impedance Cardiography - a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03876509
Other study ID # 29-478 ex 16/17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 4, 2018
Est. completion date June 30, 2020

Study information
Verified date November 2020
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 86
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Written Informed Consent - Patients with clinical indication for right heart catheterization Exclusion Criteria: - known Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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.

Locations
Country Name City State
Austria Medical University Graz, Division of Pulmonology Graz Steiermark

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnosis of pulmonary hypertension The sensitivity and specificity of Impedance Cardiography in the diagnosis of pulmonary Hypertension (as compared with the Gold Standard right heart catheterization) will be determined. 1 hour
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