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Measuring Blood Pressure in the Lung Circulation With Sonar Technology (Echo-Doppler)

This study has been terminated.
(Low recruitment)
Sponsor:
Information provided by:
Echosense Ltd.
ClinicalTrials.gov Identifier:
NCT01357746
First received: May 17, 2011
Last updated: August 17, 2013
Last verified: May 2011
  Purpose

This is a non-invasive study using a standard doppler echocardiographic transducer which records signals emanating from the lungs (TPD). These signals are caused by pulsation of blood vessels in the lung tissue.

The innovations in this study are:

  1. The software processing of the reflected ultra-sound waves from the lung rendering a reproducible, clear and strong signal in sync with the cardiac cycle,
  2. The observation based on pilot studies that blowing hard against resistance during recording (something called a Valsalva maneuver), affects the lung signal weakening it and even obliterating it as the pressure rises.

The investigators hypothesis is that since the signal comes from the blood vessels in the lung, the pressure at which the recorded signal disappears during the Valsalva maneuver represents the blood pressure in the lungs.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Procedure: Transthoracic pulmonary doppler recording
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Detection, Estimation and Characterization of Pulmonary Blood Pressure by Transthoracic Parametric Doppler (TPD)

Resource links provided by NLM:


Further study details as provided by Echosense Ltd.:

Primary Outcome Measures:
  • Reaching target enrollment number [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]
    Enrollment of 60 valid patients


Secondary Outcome Measures:
  • Lack of adverse effects [ Time Frame: 1-2 years ] [ Designated as safety issue: Yes ]
    No adverse effects are expected but since this is a new application of old technolology safety is a possible issue.


Enrollment: 60
Study Start Date: July 2011
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Transthoracic pulmonary doppler recording
    A 30 min recording of doppler signals from the right chest wall including measurements while the patient performs Valsalva maneuvers
Detailed Description:

Current methods for noninvasive measurement of pulmonary arterial blood pressure by standard echo-doppler equipment are fraught with uncertainty. So much so that patients being screened and followed for pulmonary arterial hypertension require right heart catheterization. An invasive and uncomfortable and potentially dangerous procedure.

This study is designed to confirm our preliminary observation that there is good correlation between Valsalva maneuver pressure and pulmonary arterial blood pressure.

Sixty patients undergoing right heart catheterization for clinical reasons will be studied.

The study itself is short, about 30 minutes, painless and done with the patient either sitting up in bed or semi-reclining. The probe is positioned over the right chest wall and the patient is requested to successively blow into a mouthpiece at rising pressures, to tolerance.

The results obtained using TPD to asses pulmonary arterial pressure will be compared to the results obtained at catheterization.

This is part of the development phase of the technology.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligibility

  • Age 18 years or older
  • Patients who are clinically suspected of having elevated pulmonary blood pressure , due to cardiac or cardio-pulmonary disease preferably any one or more of the conditions listed below, and due to have right heart catheterization as part of the diagnostic work-up:
  • Patients with CHF
  • Patients with primary pulmonary arterial hypertension
  • Patients with COPD
  • Patients with asthma
  • Patients with interstitial lung disease
  • Patients with sarcoidosis
  • Signed informed consent.

Exclusion Criteria:

  • Patients unable to cooperate.
  • Inability to assume a sitting or supine position
  • Patients with severe chest wall deformity
  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: NCT01357746

Locations
Israel
Department of Cardiology, Rambam Medical Center
Haifa, Israel, 35254
Sponsors and Collaborators
Echosense Ltd.
Investigators
Principal Investigator: Robert Dragu, MD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: RACHEL SCHATZBERGER/CHIEF SCIENTIFIC OFFICER, Echosense Ltd.
ClinicalTrials.gov Identifier: NCT01357746     History of Changes
Other Study ID Numbers: DOPO8
Study First Received: May 17, 2011
Last Updated: August 17, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Echosense Ltd.:
Pulmonary arterial blood pressure doppler

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

ClinicalTrials.gov processed this record on November 27, 2014