Evaluation of Lung Doppler Signals in Pulmonary Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Echosense Ltd.
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by (Responsible Party):
Echosense Ltd.
ClinicalTrials.gov Identifier:
NCT01839786
First received: April 18, 2013
Last updated: October 12, 2013
Last verified: April 2013
  Purpose

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.


Condition
Pulmonary Hypertension

Study Type: Observational
Official Title: Evaluation of Lung Doppler Signals in Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Echosense Ltd.:

Primary Outcome Measures:
  • Find specific features that characterize lung signals of PHTN patients in comparison to control patients [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The outcomes will be elaborate by statistical analysis of whole group data


Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
PHTN patients
2. Patients who underwent RHC in the past and were diagnosed with PHTN (retrospective arm)

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients suspected of PHTN

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839786

Contacts
Contact: Issahar Ben Dov, MD 972-3-5302735 Issahar.Ben-Dov@sheba.health.gov.il
Contact: Michael Segal, MD

Locations
Israel
Sheba Medical Center, Pulmonology department Recruiting
Ramat Gan, Israel
Sponsors and Collaborators
Echosense Ltd.
Sheba Medical Center
Investigators
Principal Investigator: Issahar Ben-Dov, MD Sheba Medical center, Pulmonary institute
  More Information

No publications provided

Responsible Party: Echosense Ltd.
ClinicalTrials.gov Identifier: NCT01839786     History of Changes
Other Study ID Numbers: DOP14
Study First Received: April 18, 2013
Last Updated: October 12, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Echosense Ltd.:
Pulmonary Hypertension
Doppler
Valsalva

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014