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
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Condition or disease |
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Congestive Heart Failure (CHF) |
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 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 |

Group/Cohort |
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CHF patients and Controls
CHF patients refer to Decompensated patients and Compensated patients
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- Diagnose specific patterns of doppler signals in CHF patients [ Time Frame: December 2013 ]

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
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Inclusion criteria
- Age over 50 years
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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.
- 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

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
United States, New York | |
NSLIJ Lenox Hill hospital, 100East 77 Street | |
New-York, New York, United States, 10075 |
Study Director: | Jennifer Chen, MD | Lenox Hill Hospital, 100East 77 Street New York, NY 10075 |
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 |