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Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound

Primary Purpose

Systemic Sclerosis, Pulmonary Hypertension

Status

Terminated

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Doppler ultrasound

About this trial

This is an interventional diagnostic trial for Systemic Sclerosis focused on measuring Systemic sclerosis, pulmonary hypertension

Eligibility Criteria

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

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

Sites / Locations

Reumatology department, Rabin medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Doppler ultrasound

Arm Description

Recording Doppler signals from the lungs

Outcomes

Primary Outcome Measures

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 sevirity ) resulting in typical features. The features will be implemented in a pre-determined diagnostic algorithm that will determine the overall statistical analysis success of the method in comparison to RHC data.

Secondary Outcome Measures

Full Information

NCT ID

NCT02243111

First Posted

September 8, 2014

Last Updated

January 20, 2016

Sponsor

Echosense Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02243111

Brief Title

Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound

Official Title

Evaluation of Lung Doppler Signals (LDS) in Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Terminated

Why Stopped

Low recruitment rate

Study Start Date

September 2014 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Echosense Ltd.

4. Oversight

Data Monitoring Committee

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; i.e. 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 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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Doppler ultrasound

Arm Type

Experimental

Arm Description

Recording Doppler signals from the lungs

Intervention Type

Radiation

Intervention Name(s)

Doppler ultrasound

Intervention Description

Detecting Doppler signals from the lungs on the right chest wall

Primary Outcome Measure Information:

Title

Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.

Description

Time Frame

12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Yair Molad

Organizational Affiliation

Reumatology department, Rabin medical center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Reumatology department, Rabin medical center

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound

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