Non-invasive Diagnosis of Pulmonary Hypertension by Impedance Cardiography

NCT03876509 | Completed

• 1 other identifier: 29-478 ex 16/17
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Hypertension

Keywords

impedance cardiography

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Impedance Cardiography

Impedance Cardiography

Diagnostic Test: Impedance Cardiography

Interventions

Impedance Cardiography 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.

Impedance Cardiography

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the clinical department of Pulmonology of the Medical University of Graz undergoing right heart catheterization for clinical reasons will be included

You may qualify if:

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

You may not qualify if:

• known Pregnancy

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz, Division of Pulmonology

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Cardiography, Impedance

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Plethysmography, Impedance; Plethysmography

Study Officials

• Horst Olschewski, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: March 15, 2019
• Study Start: July 4, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-11

Locations

AU (1)