Heart FailureNCT01377350
Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System
A study testing "Pneumedicare"s monitoring system. and "Pneumedicare"s monitoring system in people with Heart Failure, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The purpose of this study is to explore the feasibility of monitoring hemodynamic changes, which result from heart failure exacerbations, by recording the respiratory effort, chest wall dynamics and quantifying the development of dyspnea by using miniature mechanical sensors that are attaches to the chest. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- "Pneumedicare"s monitoring system. and "Pneumedicare"s monitoring system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to Dec 2012
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute decompensated HF
- Decompensated chronic HF in patients with NYHA class III-IV symptoms
- Age over 20 years
- Ejection fraction reduced below 35% OR doppler evidence of impaired left ventricular diastolic filling
Who cannot join
- Inability or unwillingness to follow the study protocol
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rambam Health Care Campus
Haifa, 31096
Shmuel Rispler, MD PhD, 972-4-8542180, s_rispler@rambam.health.gov.il
Amir Landesberg, MD PhD, 972-505482249, Amir@bm.technion.ac.il
About this study
The purpose of this study is to explore the feasibility of monitoring hemodynamic changes, which result from heart failure exacerbations, by recording the respiratory effort, chest wall dynamics and quantifying the development of dyspnea by using miniature mechanical sensors that are attaches to the chest.
Read the detailed description
Pulmonary veins congestion and fine changes in alveolar transudative effusion accumulation affect lung mechanics (compliance) and the respiratory effort. Moreover, the associated state of oxygen de-saturation is compensated by an increase in the respiratory effort. These changes in the respiratory effort are reflected in chest wall dynamics and may provide the earliest non-invasive sign for lung congestion and deterioration in the heart failure.
The research system comprises of patches attached to the patients' thorax that include motion sensors (Accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation. The signals are acquired by a miniaturized device that amplifies and samples the signals, stores and analyzes the data and displays the trends on the screen.
- Conditions
- Heart Failure
- Being tested
- "Pneumedicare"s monitoring system., "Pneumedicare"s monitoring system
- Keywords
- Heart failure, monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Pneumedicare"s monitoring system.Device
Also called "Pneumedicare"s monitoring system for heart failure patients
50 patients hospitalized due to the decompensated HF are considered for entry. 3 patches will be attached to the patients' thorax that include motion sensors. The system will be attached to the patients at the start of treatment. Patient's signals will be recorded during the entire treatment in the hospital, to the point that there is an improvement in their health condition.
"Pneumedicare"s monitoring systemDevice
Also called "Pneumedicare"s monitoring system for heart failure patients
Non invasive clinical follow-up of patients with HF deterioration and improvement, by a device-based algorithm. The system comprises of patches attached to the patients' thorax that include motion sensors (Accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation.
| Study group | Role | What they receive |
|---|---|---|
| "Pneumedicare"s monitoring system | Experimental | Single arm study - "Pneumedicare"s monitoring system is used for monitoring heart failure patients Receives: Device: "Pneumedicare"s monitoring system.; Device: "Pneumedicare"s monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
earliest non-invasive signs for lung congestion and deterioration in the heart failure
Exploring the feasibility of monitoring hemodynamic changes, which result from heart failure exacerbations, by recording the respiratory effort, chest wall dynamics and quantifying the development of dyspnea by using miniature mechanical sensors that are attaches to the chest.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Shmuel Rispler, MD PhD, Principal investigator, Rambam Medical Center Haifa Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377350
- Sponsor's protocol ID
- 0550-10ctil
- Other IDs
- ministry of health Israel
- Status last verified
- Mar 2011
- First submitted
- 18 May 2011
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System
- ClinicalTrials.gov ID
- NCT01377350
- Acronym / sponsor ID
- 0550-10ctil
- Conditions
- Heart Failure
- Keywords
- Heart failure, monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 21 Jun 2011 (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 explore the feasibility of monitoring hemodynamic changes, which result from heart failure exacerbations, by recording the respiratory effort, chest wall dynamics and quantifying the development of dyspnea by using miniature mechanical sensors that are attaches to the chest.
Detailed description
Pulmonary veins congestion and fine changes in alveolar transudative effusion accumulation affect lung mechanics (compliance) and the respiratory effort. Moreover, the associated state of oxygen de-saturation is compensated by an increase in the respiratory effort. These changes in the respiratory effort are reflected in chest wall dynamics and may provide the earliest non-invasive sign for lung congestion and deterioration in the heart failure.
The research system comprises of patches attached to the patients' thorax that include motion sensors (Accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation. The signals are acquired by a miniaturized device that amplifies and samples the signals, stores and analyzes the data and displays the trends on the screen.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "Pneumedicare"s monitoring system | Experimental | Device: "Pneumedicare"s monitoring system., Device: "Pneumedicare"s monitoring systemSingle arm study - "Pneumedicare"s monitoring system is used for monitoring heart failure patients |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute decompensated HF
- Decompensated chronic HF in patients with NYHA class III-IV symptoms
- Age over 20 years
- Ejection fraction reduced below 35% OR doppler evidence of impaired left ventricular diastolic filling
Key exclusion criteria (1 listed)
- Inability or unwillingness to follow the study protocol
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 |
|---|---|---|
| "Pneumedicare"s monitoring system.Also: "Pneumedicare"s monitoring system for heart failure patients50 patients hospitalized due to the decompensated HF are considered for entry. 3 patches will be attached to the patients' thorax that include motion sensors. The system will be attached to the patients at the start of treatment. Patient's signals will be recorded during the entire treatment in the hospital, to the point that there is an improvement in their health condition. | Device | "Pneumedicare"s monitoring system |
| "Pneumedicare"s monitoring systemAlso: "Pneumedicare"s monitoring system for heart failure patientsNon invasive clinical follow-up of patients with HF deterioration and improvement, by a device-based algorithm. The system comprises of patches attached to the patients' thorax that include motion sensors (Accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation. | Device | "Pneumedicare"s monitoring system |
Primary outcome
earliest non-invasive signs for lung congestion and deterioration in the heart failure
Time frame: 18 months
Exploring the feasibility of monitoring hemodynamic changes, which result from heart failure exacerbations, by recording the respiratory effort, chest wall dynamics and quantifying the development of dyspnea by using miniature mechanical sensors that are attaches to the chest.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2011.
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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 Medical Center Haifa Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Pneumedicare"s monitoring system. and "Pneumedicare"s monitoring system in people with Heart Failure, run by Rambam Health Care Campus 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 4 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: status not confirmed, as of the sponsor's last update on 21 Jun 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shmuel rispler, MD PhD (972-4-8542180, s_rispler@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
earliest non-invasive signs for lung congestion and deterioration in the heart failure (time frame: 18 months). 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 21 Jun 2011.