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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Israel1 site
  • EMD Rambam Hospital

    Haifa

Other trials in Israel

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:

  1. 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:
  2. Dyspnea at rest or with minimal activity
  3. Rales on auscultation
  4. Evidence of pulmonary congestion or edema on chest X-ray.
  5. BNP level >400 pg/ml This subgroup will be recruited in the emergency medicine department (EMD) following initial treatment and stabilization.
  6. 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.
  7. 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 groups in NCT01940328
Study groupRoleWhat they receive
Decompensated CHFpatients with acute pulmonary congestion or pulmonary edema
Receives: Device: Transchoracic ultrasound Doppler
Compensated CHFpatients 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 patientspatients 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.

  1. 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.

  1. First posted12 Sep 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionDec 2015
  4. Study completionMar 2016

Resources

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
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

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.

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