Congestive Heart Failure (CHF)NCT01831713
Pulmonary Blood Flow Measurements in CHF Patients
An observational study of Congestive Heart Failure (CHF), run by Echosense Ltd. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Congestive Heart Failure (CHF)
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CHF patients admitted to the cardiology telemetry unit and to the CCU
Who may be able to join
- Age over 50 years
- Belongs to one of the following categories:
- 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.
- Compensated CHF: patients with significant CHF (NYHA II-IV) who are well controlled and without evidence of pulmonary congestion or pulmonary edema on admission.
- Non-CHF controls: patients without CHF and without any of the following: pulmonary hypertension, any known pulmonary disease, uncontrolled hypertension.
- Signed Informed Consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NSLIJ Lenox Hill hospital, 100East 77 Street
New York, New York, 10075
About this study
Official title: Evaluation of Pulmonary Blood Flow Patterns Using Transthoracic Doppler in Patients With Congestive Heart Failure
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.
Read the 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.
- Conditions
- Congestive Heart Failure (CHF)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CHF patients and Controls | CHF patients refer to Decompensated patients and Compensated patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnose specific patterns of doppler signals in CHF patients
Measured: December 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startSep 2012
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Changing staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart Failure (CHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Echosense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Chen, MD, Study director, Lenox Hill Hospital, 100East 77 Street New York, NY 10075
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831713
- Sponsor's protocol ID
- NIH DOP08
- Status last verified
- Aug 2012
- First submitted
- 11 Apr 2013
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pulmonary Blood Flow Patterns Using Transthoracic Doppler in Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT01831713
- Acronym / sponsor ID
- NIH DOP08
- Conditions
- Congestive Heart Failure (CHF)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Changing staff
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Echosense Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHF patients and Controls | – | –CHF patients refer to Decompensated patients and Compensated patients |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CHF patients admitted to the cardiology telemetry unit and to the CCU
Key inclusion criteria (6 listed)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnose specific patterns of doppler signals in CHF patients
Time frame: December 2013
Results and safety
The study was stopped early (reason given: Changing staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Chen, MD study director
Lenox Hill Hospital, 100East 77 Street New York, NY 10075
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure (CHF), run by Echosense Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Changing staff). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnose specific patterns of doppler signals in CHF patients (time frame: December 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2015.