Congestive Heart FailureSleeves-BickelNCT01691417
Pneumatic Sleeves and Congestive Heart Failure
A study testing Intermittent Sequntial Pnumatic Compression Leg Sleeves in people with Congestive Heart Failure, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Based on the reversal of the adverse cardiovascular parameters during Laproscopic Surgery and its influence on cardiac activity in healthy subjects, the investigators expect to improved cardiac function in patients suffering from congestive heart failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Intermittent Sequntial Pnumatic Compression Leg Sleeves
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- CHF (as clinically evaluated and asessed by TTE)
- Gave informed consent
- NYHA Class II-III
- LVEF equal or less than 40%
Who cannot join
- Patients who could not sign informed consent
- NYHA Class IV
- Oxygen saturation less than 90% under room air
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Intermittent Sequential Pneumatic Compression (ISPC) Leg Sleeves on Cardiac Performance in Patients With Congestive Heart Failure
Based on the reversal of the adverse cardiovascular parameters during Laproscopic Surgery and its influence on cardiac activity in healthy subjects, the investigators expect to improved cardiac function in patients suffering from congestive heart failure.
- Conditions
- Congestive Heart Failure
- Being tested
- Intermittent Sequntial Pnumatic Compression Leg Sleeves
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Sequntial Pnumatic Compression Leg SleevesDevice
| Study group | Role | What they receive |
|---|---|---|
| Pneumatic Sleeves | Experimental | Not described Receives: Device: Intermittent Sequntial Pnumatic Compression Leg Sleeves |
| Congestive Heart Failure Patients | Experimental | Not described Receives: Device: Intermittent Sequntial Pnumatic Compression Leg Sleeves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
Secondary outcomes (1)
Systemic vascular resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
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
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691417
- Sponsor's protocol ID
- Sleeves-Bickel
- Acronym
- Sleeves-Bickel
- Status last verified
- Sep 2012
- First submitted
- 9 Sep 2012
- Last updated
- 24 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intermittent Sequential Pneumatic Compression (ISPC) Leg Sleeves on Cardiac Performance in Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT01691417
- Acronym / sponsor ID
- Sleeves-Bickel / Sleeves-Bickel
- Conditions
- Congestive Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- First posted
- 24 Sep 2012 (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.
Based on the reversal of the adverse cardiovascular parameters during Laproscopic Surgery and its influence on cardiac activity in healthy subjects, the investigators expect to improved cardiac function in patients suffering from congestive heart failure.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumatic Sleeves | Experimental | Device: Intermittent Sequntial Pnumatic Compression Leg Sleeves |
| Congestive Heart Failure Patients | Experimental | Device: Intermittent Sequntial Pnumatic Compression Leg Sleeves |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- CHF (as clinically evaluated and asessed by TTE)
- Gave informed consent
- NYHA Class II-III
- LVEF equal or less than 40%
Key exclusion criteria (3 listed)
- Patients who could not sign informed consent
- NYHA Class IV
- Oxygen saturation less than 90% under room air
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 |
|---|---|---|
| Intermittent Sequntial Pnumatic Compression Leg Sleeves | Device | Congestive Heart Failure Patients, Pneumatic Sleeves |
Primary outcome
Cardiac Output
1 secondary outcome
Systemic vascular resistance
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 24 Sep 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Sequntial Pnumatic Compression Leg Sleeves in people with Congestive Heart Failure, run by Western Galilee Hospital-Nahariya 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 3 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 24 Sep 2012. 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?
Cardiac Output. 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 24 Sep 2012.