Pulmonary Blood Flow Measurements in CHF Patients

Status Terminated

Clinical Trial 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.

Clinical Trial 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01831713
Study type	Observational
Source	Echosense Ltd.
Contact
Status	Terminated
Phase	N/A
Start date	September 2012
Completion date	April 2015

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT01744210` - Evaluation of Blood Flow Patterns in Lung Blood Vessels Using Ultrasound Technique in Patients With Congestive Heart Failure	N/A
Completed	`NCT00211874` - Improving Heart Failure Care in Minority Communities	N/A
Completed	`NCT01960907` - Clinical Trials for Elderly Patients With Multiple Disease	N/A
Terminated	`NCT00406575` - Recombinant Human Relaxin for the Treatment of Decompensated CHF	Phase 2
Completed	`NCT00309764` - CHF Management Using Telemedicine	N/A
Completed	`NCT02034045` - Expanding Paramedicine in the Community	N/A
Completed	`NCT01855022` - A Trial to Reduce Readmissions Using Motivational Interviewing and Interactive Voice Response	N/A
Completed	`NCT02983812` - Developing Enhanced Prediction Models
Completed	`NCT01044290` - Outlook Quality of Life Intervention Study	N/A
Completed	`NCT00734045` - Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples	N/A
Not yet recruiting	`NCT01414439` - Group Psychotherapy Among Congestive Heart Failure Patients	N/A
Approved for marketing	`NCT00528320` - Clinical Evaluation of Cardiac Resynchronization Therapy (CRT) Using the Ovatio CRT Implantable Cardioverter-defibrillator (ICD) System	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.