Evaluation of Pulmonary Doppler Signals in Patients With Systemic Sclerosis(SSc)

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02278445
• Other study ID #: DOP22_3
• Status: Withdrawn
• Phase: N/A
• First received: October 27, 2014
• Last updated: November 29, 2015
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2014
• Source: Echosense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Radiation:
• Doppler ultrasound
Recording Doppler ultrasound noninvasively from the right chest wall

Device:
• Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel)

Locations

Country	Name	City	State
Israel	Sheba Medical Center, Pulmonology department	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Echosense Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 month	No