NCT01357746

Brief Summary

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. 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Last Updated

August 20, 2013

Status Verified

May 1, 2011

Enrollment Period

11 months

First QC Date

May 17, 2011

Last Update Submit

August 17, 2013

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary arterial blood pressure doppler

Outcome Measures

Primary Outcomes (1)

  • Reaching target enrollment number

    Enrollment of 60 valid patients

    1-2 years

Secondary Outcomes (1)

  • Lack of adverse effects

    1-2 years

Interventions

Transthoracic pulmonary doppler recordingPROCEDURE

A 30 min recording of doppler signals from the right chest wall including measurements while the patient performs Valsalva maneuvers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Rambam Medical Center

Haifa, 35254, Israel

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Robert Dragu, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 23, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2012

Last Updated

August 20, 2013

Record last verified: 2011-05

Locations

IL(1)