Pulmonary EdemaNCT01940328
Measurements of Doppler Signals Noninvasively From the Lung in Congestive Heart Failure
An observational study of Pulmonary Edema, run by Echosense Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the lung Doppler signals in left HF patients with and without pulmonary congestion (i.e. decompensated left HF patients and compensated left HF patients respectively), in comparison to a control group of subjects without CHF (non-CHF controls), in order to determine the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Edema
- What is being tested?
- Transchoracic ultrasound Doppler
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to Mar 2016
- How long will I take part?
- 3 Days
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 150 mpatients will be recruited during 18 months: 50 Acute decompensated left heart failure;50 compensated left heart failure;50 non-CHF controls.
Who may be able to join
- Age over 18 years
- Belongs to one of the following categories:
- Acute decompensated left HF: patients with acute pulmonary congestion or pulmonary edema diagnosed on the basis of all of the following criteria:
- Dyspnea at rest or with minimal activity
- Rales on auscultation
- Evidence of pulmonary congestion or edema on chest X-ray.
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- BNP level >400 pg/ml
- Compensated left HF: patients with significant stable left HF (NYHA II-III) who are on optimal medical treatment for CHF, and are without clinical or laboratory evidence of pulmonary congestion. The following 3 criteria must be met:
- No dyspnea at rest
- No rales on auscultation
- BNP levels < 100 pg/ml
- Non-CHF controls: patients without CHF and without uncontrolled hypertension.
- 3 Signed Informed Consent
Who cannot join
- Decompensated left HF subgroup \& Non CHF controls
- Pneumonia- currently or in the past 1 month prior to inclusion
- Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS)
- Interstitial lung disease
- Severe kyphosis, scoliosis or chest wall deformity
- Pregnant women
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- Compensated left HF subgroup
- 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
- Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS)
- Current or past pulmonary embolism
- Large right sided pleural effusion
- Severe kyphosis, scoliosis or chest wall deformity
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Lung Doppler Signals in Congestive Heart Failure(CHF)
The purpose of this study is to evaluate the lung Doppler signals in left HF patients with and without pulmonary congestion (i.e. decompensated left HF patients and compensated left HF patients respectively), in comparison to a control group of subjects without CHF (non-CHF controls), in order to determine the diagnostic value of this non-invasive method in CHF. If this method will prove to be of diagnostic value, it could potentially be used to diagnose and monitor CHF patients in both inpatient and outpatient settings.
Read the detailed description
Study Participants A total of 150 patients will be recruited for this study over a span of 18 months.
Patients will be divided into 3 subgroups:
- Acute decompensated left heart failure- Patients are eligible for enrollment if they presented to the emergency department within the previous few hours with acute pulmonary congestion or pulmonary edema, diagnosed on the basis of all of the following criteria:
- Dyspnea at rest or with minimal activity
- Rales on auscultation
- Evidence of pulmonary congestion or edema on chest X-ray.
- BNP level >400 pg/ml This subgroup will be recruited in the emergency medicine department (EMD) following initial treatment and stabilization.
- Compensated left heart failure - Patients with significant stable left HF (NYHA II-III) who are on optimal medical treatment for CHF and are without clinical or laboratory evidence of pulmonary congestion (i.e. patients without dyspnea at rest, without rales on auscultation and with BNP levels < 100 pg/ml). This subgroup will be recruited among inpatients and/or outpatients at the Rambam campus.
- Non-CHF controls (patients without CHF and without uncontrolled hypertension). This subgroup will be recruited among inpatients and/or outpatients at the Rambam health care campus.
Study measurements
For the compensated left HF patients and the non-CHF controls, measurements will be done once following inclusion.
For the decompensated left HF patients, several measurements will be conducted, both following inclusion (at the EMD) and each day during hospitalization (at the internal medicine department).
Measurements following inclusion:
Following informed consent and applying the inclusion and exclusion criteria, all eligible patients will undergo physical examination including weight, vital signs (blood pressure, heart rate, respiratory rate, O2 saturation by pulse oximetry) and a full assessment of CHF status by physical examination (lung auscultation, assessment of leg edema, weight, JVP etc.). (See figure 2). An ECG recording will be performed and a blood test for BNP will be drawn for all patients.
For the assessment of dyspnea, decompensated left HF patients will be asked to indicate their level of dyspnea on a visual analogue scale (3) and/or a 7-points categorical Likert scale (4).
Chest X-ray: Decompensated patients will undergo chest X ray (CXR) as part of the regular evaluation in the EMD. The 2 other subgroups will undergo CXR only if a recent CXR (<6 months) is not available, or if clinically indicated.
Echocardiography: an attempt will be made to perform echocardiography in the EMD for all decompensated patients who are in sinus rhythm, including a full diastolic assessment. However, due to the limited availability of the echocardiography service, not all patients will undergo echo at the EMD and therefore this examination is considered optional.
A recent (<6 months) echocardiography is required for the 2 other subgroups. If a recent echo is not available, a new one will be done as close as possible to inclusion.
Lung Doppler signals will be recorded in sitting position from selected locations over the right chest wall. If the subject is unable to sit in a chair, the headrest of the patient's bed will be tilted upwards to about 45 degrees. Regarding the decompensated left HF patients, the first measurement of LDS will take place as soon as possible after admission to the emergency medicine department, providing the patient has been adequately treated and stabilized and is willing and able to sign an informed consent form. The LDS measurement will be repeated twice more at the EMD at 1 hour intervals. LDS will be recorded only once for the compensated patients and the non-CHF controls.
Follow up measurements during hospitalization (decompensated patients only) During their hospital stay in the internal medicine department, decompensated left HF patients will repeat part of the former study measurements.
- Conditions
- Pulmonary Edema
- Being tested
- Transchoracic ultrasound Doppler
- Keywords
- Ultrasound Doppler, Congestive heart failure, Pulmonary Edema
- Medical subject headings
- Pulmonary Edema, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transchoracic ultrasound DopplerDevice
| Study group | Role | What they receive |
|---|---|---|
| Decompensated CHF | patients with acute pulmonary congestion or pulmonary edema Receives: Device: Transchoracic ultrasound Doppler | |
| Compensated CHF | patients with significant stable left HF (NYHA II-III) who are on optimal medical treatment for CHF, and are without clinical or laboratory evidence of pulmonary congestion Receives: Device: Transchoracic ultrasound Doppler | |
| Non CHF patients | patients without CHF and without uncontrolled hypertension. Receives: Device: Transchoracic ultrasound Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnose specific pattern of LDS in patients by features as velocity, power etc in comparison to controls
Measured: 1.5y to collect all data and obtain a diagnostic pattern
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EdemaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Echosense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shmuel Rispler, MD, PhD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940328
- Sponsor's protocol ID
- DOP13
- Status last verified
- Aug 2013
- First submitted
- 9 Sep 2013
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lung Doppler Signals in Congestive Heart Failure(CHF)
- ClinicalTrials.gov ID
- NCT01940328
- Acronym / sponsor ID
- DOP13
- Conditions
- Pulmonary Edema
- Keywords
- Ultrasound Doppler, Congestive heart failure, Pulmonary Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Echosense Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Sep 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.
The purpose of this study is to evaluate the lung Doppler signals in left HF patients with and without pulmonary congestion (i.e. decompensated left HF patients and compensated left HF patients respectively), in comparison to a control group of subjects without CHF (non-CHF controls), in order to determine the diagnostic value of this non-invasive method in CHF. If this method will prove to be of diagnostic value, it could potentially be used to diagnose and monitor CHF patients in both inpatient and outpatient settings.
Detailed description
Study Participants A total of 150 patients will be recruited for this study over a span of 18 months.
Patients will be divided into 3 subgroups:
- Acute decompensated left heart failure- Patients are eligible for enrollment if they presented to the emergency department within the previous few hours with acute pulmonary congestion or pulmonary edema, diagnosed on the basis of all of the following criteria:
- Dyspnea at rest or with minimal activity
- Rales on auscultation
- Evidence of pulmonary congestion or edema on chest X-ray.
- BNP level >400 pg/ml This subgroup will be recruited in the emergency medicine department (EMD) following initial treatment and stabilization.
- Compensated left heart failure - Patients with significant stable left HF (NYHA II-III) who are on optimal medical treatment for CHF and are without clinical or laboratory evidence of pulmonary congestion (i.e. patients without dyspnea at rest, without rales on auscultation and with BNP levels < 100 pg/ml). This subgroup will be recruited among inpatients and/or outpatients at the Rambam campus.
- Non-CHF controls (patients without CHF and without uncontrolled hypertension). This subgroup will be recruited among inpatients and/or outpatients at the Rambam health care campus.
Study measurements
For the compensated left HF patients and the non-CHF controls, measurements will be done once following inclusion.
For the decompensated left HF patients, several measurements will be conducted, both following inclusion (at the EMD) and each day during hospitalization (at the internal medicine department).
Measurements following inclusion:
Following informed consent and applying the inclusion and exclusion criteria, all eligible patients will undergo physical examination including weight, vital signs (blood pressure, heart rate, respiratory rate, O2 saturation by pulse oximetry) and a full assessment of CHF status by physical examination (lung auscultation, assessment of leg edema, weight, JVP etc.). (See figure 2). An ECG recording will be performed and a blood test for BNP will be drawn for all patients.
For the assessment of dyspnea, decompensated left HF patients will be asked to indicate their level of dyspnea on a visual analogue scale (3) and/or a 7-points categorical Likert scale (4).
Chest X-ray: Decompensated patients will undergo chest X ray (CXR) as part of the regular evaluation in the EMD. The 2 other subgroups will undergo CXR only if a recent CXR (<6 months) is not available, or if clinically indicated.
Echocardiography: an attempt will be made to perform echocardiography in the EMD for all decompensated patients who are in sinus rhythm, including a full diastolic assessment. However, due to the limited availability of the echocardiography service, not all patients will undergo echo at the EMD and therefore this examination is considered optional.
A recent (<6 months) echocardiography is required for the 2 other subgroups. If a recent echo is not available, a new one will be done as close as possible to inclusion.
Lung Doppler signals will be recorded in sitting position from selected locations over the right chest wall. If the subject is unable to sit in a chair, the headrest of the patient's bed will be tilted upwards to about 45 degrees. Regarding the decompensated left HF patients, the first measurement of LDS will take place as soon as possible after admission to the emergency medicine department, providing the patient has been adequately treated and stabilized and is willing and able to sign an informed consent form. The LDS measurement will be repeated twice more at the EMD at 1 hour intervals. LDS will be recorded only once for the compensated patients and the non-CHF controls.
Follow up measurements during hospitalization (decompensated patients only) During their hospital stay in the internal medicine department, decompensated left HF patients will repeat part of the former study measurements.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Decompensated CHF | – | Device: Transchoracic ultrasound Dopplerpatients with acute pulmonary congestion or pulmonary edema |
| Compensated CHF | – | Device: Transchoracic ultrasound Dopplerpatients with significant stable left HF (NYHA II-III) who are on optimal medical treatment for CHF, and are without clinical or laboratory evidence of pulmonary congestion |
| Non CHF patients | – | Device: Transchoracic ultrasound Dopplerpatients without CHF and without uncontrolled hypertension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 150 mpatients will be recruited during 18 months: 50 Acute decompensated left heart failure;50 compensated left heart failure;50 non-CHF controls.
Key inclusion criteria (13 listed)
- Age over 18 years
- Belongs to one of the following categories:
- Acute decompensated left HF: patients with acute pulmonary congestion or pulmonary edema diagnosed on the basis of all of the following criteria:
- Dyspnea at rest or with minimal activity
- Rales on auscultation
Key exclusion criteria (17 listed)
- Decompensated left HF subgroup \& Non CHF controls
- Pneumonia- currently or in the past 1 month prior to inclusion
- Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS)
- Interstitial lung disease
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transchoracic ultrasound Doppler | Device | Compensated CHF, Decompensated CHF, Non CHF patients |
Primary outcome
Diagnose specific pattern of LDS in patients by features as velocity, power etc in comparison to controls
Time frame: 1.5y to collect all data and obtain a diagnostic pattern
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
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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.
Shmuel Rispler, MD, PhD principal investigator
Rambam Health Care Campus
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 Pulmonary Edema, run by Echosense Ltd. at 1 site in Israel.
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 13 inclusion and 17 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: finished, as of the sponsor's last update on 8 Feb 2017. 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 Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 pattern of LDS in patients by features as velocity, power etc in comparison to controls (time frame: 1.5y to collect all data and obtain a diagnostic pattern). 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 8 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.