Evaluation of Lung Doppler Signals in Pulmonary Hypertension

NCT ID: NCT01839786

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2017-02-28

Brief 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.

Detailed 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

Conditions

Pulmonary Hypertension

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

PHTN patients

2\. Patients who underwent RHC in the past and were diagnosed with PHTN (retrospective arm)

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: collaborator

Echosense Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Issahar Ben-Dov, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical center, Pulmonary institute

Locations

Sheba Medical Center, Pulmonology department

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

DOP14

Identifier Type: -

Identifier Source: org_study_id