Evaluation of Lung Doppler Signals in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Evaluation of Lung Doppler Signals in Pulmonary Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01839786
• Other study ID #: DOP14
• Status: Terminated
• Phase: N/A
• First received: April 18, 2013
• Last updated: March 19, 2017
• Start date: May 2013
• Est. completion date: February 2017

Study information

• Verified date: April 2013
• Source: Echosense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Echosense Ltd.	Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Find specific features that characterize lung signals of PHTN patients in comparison to control patients	The outcomes will be elaborate by statistical analysis of whole group data	18 months