Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02246348

Enrollment

Registered

2014-09-22

Start date

2014-09-30

Completion date

2015-12-31

Last updated

2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension, Systemic Sclerosis

Keywords

Systemic Sclerosis, Pulmonary hypertension, Lung Doppler signals

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.

Interventions

RADIATIONDoppler ultrasound

Recording Doppler ultrasound noninvasively from the right chest wall

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.	12 month	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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026