Pulmonary Blood Flow Measurements in CHF Patients

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ClinicalTrials.gov Identifier: NCT01831713

Recruitment Status : Terminated (Changing staff)

First Posted : April 15, 2013

Last Update Posted : July 15, 2015

Sponsor:

Information provided by (Responsible Party):

Echosense Ltd.

Study Description

Brief Summary:

Historically, transthoracic Doppler echocardiography has been unable to provide interpretable data of blood flow within the lung parenchyma because of air attenuation of Doppler signals. Recently, a transthoracic Doppler system known as the Sonara/tek Transcranial Doppler (TCD) System has been developed that can identify parenchymal pulmonary blood flow (PPBF) signals. The ability to non-invasively collect information regarding the pulmonary aspect of the cardio-pulmonary system may provide valuable information and new insights into the structural and functional characteristics of the lung parenchyma and vasculature in health and disease states.

Condition or disease
Congestive Heart Failure (CHF)

Detailed Description:

This new system was previously studied among 31 healthy volunteers and one subject with atrial fibrillation.1 Pulsed spectral Doppler signals were obtained over the chest wall using a signal processing and algorithm package in conjunction with a non-imaging Doppler device coupled with an electrocardiogram. Clear reproducible lung Doppler signals (LDS) originating from different elements and phases of cardiac activity that generate mechanical waves which propagate throughout the lung were expressed in pulsatile changes in ultrasound reflections.

After the completion of the first 25 patients in our pilot study, we have received some valuable information. After assessing patients with CHF and pulmonary hypertension, we identified signals particular to the CHF group. There were unique features that were never observed in the normal patients. On top of the regular Lung Doppler signals seen in normal patients, high velocity "disorganized" variable signals that were not synchronous with the heart beat, but rather sometimes with respiration were observed. We believe that the signals may represent popping open of small bronchi surrounded by "water filled" parenchyma. These events that generate very strong reflector like signals may represent the movement of fluid at the blood vessel-alveolar air junction.

Study Design


Study Type :	Observational
Estimated Enrollment :	200 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Evaluation of Pulmonary Blood Flow Patterns Using Transthoracic Doppler in Patients With Congestive Heart Failure
Study Start Date :	September 2012
Actual Primary Completion Date :	April 2015
Actual Study Completion Date :	April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
CHF patients and Controls CHF patients refer to Decompensated patients and Compensated patients

Outcome Measures

Primary Outcome Measures :

Diagnose specific patterns of doppler signals in CHF patients [ Time Frame: December 2013 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	50 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

CHF patients admitted to the cardiology telemetry unit and to the CCU

Criteria

Inclusion Criteria:

Inclusion criteria
1. Age over 50 years
2. Belongs to one of the following categories:
  
  A. Decompensated CHF: patients with overt pulmonary congestion or pulmonary edema on admission, evident both clinically and by chest x-ray. Patients may be with or without a Swan-Ganz catheter.
  
  B. Compensated CHF: patients with significant CHF (NYHA II-IV) who are well controlled and without evidence of pulmonary congestion or pulmonary edema on admission.
  
  C. Non-CHF controls: patients without CHF and without any of the following: pulmonary hypertension, any known pulmonary disease, uncontrolled hypertension.
3. Signed Informed Consent

Exclusion Criteria:

Chronic obstructive pulmonary disease (COPD) Asthma Interstitial lung disease Any other obstructive or restrictive lung diseases Pneumonia- currently or in the past 3 months prior to inclusion Current or past pulmonary embolism Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS) Right sided pleural effusion that is not mild Severe kyphosis, scoliosis or chest wall deformity

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831713

Locations


United States, New York
NSLIJ Lenox Hill hospital, 100East 77 Street
New-York, New York, United States, 10075

Sponsors and Collaborators

Echosense Ltd.

Investigators


Study Director:	Jennifer Chen, MD	Lenox Hill Hospital, 100East 77 Street New York, NY 10075

More Information


Responsible Party:	Echosense Ltd.
ClinicalTrials.gov Identifier:	NCT01831713 History of Changes
Other Study ID Numbers:	NIH DOP08
First Posted:	April 15, 2013 Key Record Dates
Last Update Posted:	July 15, 2015
Last Verified:	August 2012

Additional relevant MeSH terms:


Heart Failure Heart Diseases Cardiovascular Diseases

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