Congestive Heart FailureNCT00382746
EarlySense Monitoring Device Evaluation on CHF Patients
An observational study of Congestive Heart Failure, run by EarlySense Ltd. at 1 site in Israel.
Trial summary
CHF patients will be monitored using EarlySense ES-16 device and will simultaneously fill diaries and log their weight daily. The data collected and analyzed by the ES-16 device will be correlated with the CHF status data. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- EarlySense monitoring device
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2006to Mar 2008
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 45 years old
- CHF class II or III with LVEF<40%
- Hospitalized at least once for CHF deterioration over previous 12 month period
- Able and willing to cooperate with this trial for at least a 3 month period
- Home close to participating center
Who cannot join
- Recent (within 3 month) admission to ICU or CC-ICU due to severe CHF episode requiring artificial ventilation
- Asthma or COPD
Trial locations and contacts
1 site in 1 country.
About this study
CHF patients will be monitored using EarlySense ES-16 device and will simultaneously fill diaries and log their weight daily. The data collected and analyzed by the ES-16 device will be correlated with the CHF status data.
- Conditions
- Congestive Heart Failure
- Being tested
- EarlySense monitoring device
- Keywords
- 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.
EarlySense monitoring deviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
CHF
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionNov 2007
- Study completionMar 2008
Why it stopped: No need
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EarlySense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Investigators
- Shmuel Rispler, M.D., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382746
- Sponsor's protocol ID
- ES- CI 02
- Status last verified
- Apr 2008
- First submitted
- 28 Sep 2006
- Last updated
- 19 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EarlySense Monitoring Device Evaluation on CHF Patients
- ClinicalTrials.gov ID
- NCT00382746
- Acronym / sponsor ID
- ES- CI 02
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive, Heart, Failure, CHF
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No need
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EarlySense Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Study start
- Oct 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 29 Sep 2006 (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.
CHF patients will be monitored using EarlySense ES-16 device and will simultaneously fill diaries and log their weight daily. The data collected and analyzed by the ES-16 device will be correlated with the CHF status data.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 45 years old
- CHF class II or III with LVEF<40%
- Hospitalized at least once for CHF deterioration over previous 12 month period
- Able and willing to cooperate with this trial for at least a 3 month period
- Home close to participating center
Key exclusion criteria (2 listed)
- Recent (within 3 month) admission to ICU or CC-ICU due to severe CHF episode requiring artificial ventilation
- Asthma or COPD
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 |
|---|---|---|
| EarlySense monitoring device | Device | – |
Primary outcome
CHF
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
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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, M.D. 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 Congestive Heart Failure, run by EarlySense 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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 19 Jul 2016. 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 was withdrawn before enrolling participants, so there are no results.
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?
CHF (time frame: 1 month). 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 19 Jul 2016.