Evaluation of Lung Doppler Signals in Pulmonary Hypertension

March 19, 2017 updated by: Echosense Ltd.
The purpose of this study is to evaluate the lung Doppler signals in patients with pulmonary hypertension that undergo (prospective arm) or underwent (retrospective arm) right heart catheterization (RHC) in order to assess whether this non-invasive tool could be used in pulmonary hypertension diagnosis and monitoring.

Study Overview

Status

Terminated

Conditions

Detailed Description

PROTOCOL SUMMARY

Title: Evaluation of lung Doppler signals (LDS) in pulmonary hypertension (PHTN) Device: SONARA/tek transcranial Doppler (TCD) system Study Objectives: To evaluate the LDS in patients with PHTN that undergo (prospective arm) or underwent (retrospective arm) right heart catheterization (RHC) in order to assess whether these signals can be used in pulmonary hypertension diagnosis and monitoring.

Study Design:

Two study arms:

  1. Prospective arm to measure LDS during right heart catheterization in patients undergoing the procedure for evaluation of PHTN.
  2. Retrospective arm to measure LDS in patients in whom previous RHC confirmed the presence of PHTN.

Recruitment target: Prospective arm: 50 patients during 18 months. Retrospective arm: 50 patients during 18 months.

Study Population:

  1. Patients suspected of PHTN by echocardiogram, who are scheduled to undergo RHC (prospective arm)
  2. Patients who underwent RHC in the past and were diagnosed with PHTN (retrospective arm)

Study endpoint:

  1. Comparison of pulmonary blood pressures at rest, following vasodilator medication and following upper extremities exercise as measured by RHC and by the LDS during the Valsalva maneuver.
  2. Determining LDS characteristics of PHTN patients

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Sheba Medical Center, Pulmonology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients suspected of PHTN

Description

Inclusion Criteria:

  1. Prospective arm:

    • Man or woman aged over 18.
    • With suspicion or diagnosis of pulmonary hypertension.
    • Scheduled to undergo right heart catheterization
    • Able and willing to give informed consent.

  2. Retrospective arm:

    • Man or woman aged over 18.
    • With diagnosis of pulmonary hypertension confirmed by right heart catheterization in the past.
    • Able and willing to give informed consent.

Exclusion Criteria:

  1. Both arms:

    • Minor (aged < 18).
    • People unable or unwilling to give informed consent.
    • Hemodynamically unstable patients.
    • Pregnant women.

  2. Prospective arm only:

    • Patients with contra-indication to right heart catheterization.
    • Patients incapable of performing a Valsalva maneuver.
    • Patients with recent myocardial infarction, high degree AV block, severe aortic stenosis or glaucoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PHTN patients
2. Patients who underwent RHC in the past and were diagnosed with PHTN (retrospective arm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Find specific features that characterize lung signals of PHTN patients in comparison to control patients
Time Frame: 18 months
The outcomes will be elaborate by statistical analysis of whole group data
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Echosense Ltd.

Collaborators

Sheba Medical Center

Investigators

  • Principal Investigator: Issahar Ben-Dov, MD, Sheba Medical center, Pulmonary institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

April 18, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 19, 2017

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOP14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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