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Evaluating Pulmonary Arterial Hypertension in Patients With Systemic Sclerosis

Primary Purpose

Systemic Sclerosis, Pulmonary Hypertension

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound radiation
Sponsored by
Echosense Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Systemic Sclerosis focused on measuring Systemic Sclerosis, Pulmonary hypertension, Lung Doppler Signals

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Able and willing to give signed informed consent prior to enrollment
  2. Male or female, ≥ 18 years of age
  3. Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den Hoogen 2013): Score ≥ 9.
  4. Patients with RHC data available from measurement within 3 weeks prior to TPD assessment
  5. No change in or initiation of PAH specific therapy between the last RHC and TPD

Exclusion Criteria:

  1. People unable or unwilling to give informed consent.
  2. PCWP or LVEDP > 15 mmHg
  3. Any PH etiology outside Group 1 (Dana Point, 2008)
  4. Pregnant women
  5. Patients having severe chest wall deformity

Sites / Locations

    Outcomes

    Primary Outcome Measures

    1. Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.
    Analyze Doppler data of 4 SSc groups (according to pulmonary hypertension severity) resulting in typical features. The features will be implemented in a pre-determined diagnostic algorithm that will determine the overall statistical success of the method in comparison to RHC data.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 13, 2015
    Last Updated
    November 29, 2015
    Sponsor
    Echosense Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02339961
    Brief Title
    Evaluating Pulmonary Arterial Hypertension in Patients With Systemic Sclerosis
    Official Title
    Evaluation of Lung Doppler Signals (LDS) in Detecting Pulmonary Arterial Hypertension in Patients With Systemic Sclerosis (SSc)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No patients
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    January 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Echosense Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package- the Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS (Lung Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in detecting PAH in SSc patients will be assessed in the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic Sclerosis, Pulmonary Hypertension
    Keywords
    Systemic Sclerosis, Pulmonary hypertension, Lung Doppler Signals

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Radiation
    Intervention Name(s)
    Ultrasound radiation
    Intervention Description
    Recording Doppler ultrasound noninvasively from the right chest wall
    Primary Outcome Measure Information:
    Title
    1. Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.
    Description
    Analyze Doppler data of 4 SSc groups (according to pulmonary hypertension severity) resulting in typical features. The features will be implemented in a pre-determined diagnostic algorithm that will determine the overall statistical success of the method in comparison to RHC data.
    Time Frame
    12 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able and willing to give signed informed consent prior to enrollment Male or female, ≥ 18 years of age Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den Hoogen 2013): Score ≥ 9. Patients with RHC data available from measurement within 3 weeks prior to TPD assessment No change in or initiation of PAH specific therapy between the last RHC and TPD Exclusion Criteria: People unable or unwilling to give informed consent. PCWP or LVEDP > 15 mmHg Any PH etiology outside Group 1 (Dana Point, 2008) Pregnant women Patients having severe chest wall deformity
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sara Pel
    Organizational Affiliation
    Reumatology institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluating Pulmonary Arterial Hypertension in Patients With Systemic Sclerosis

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