EdemaNCT01112150
Effect of Normatec Pump for Relief of Leg Edema
A study testing NormaTec Pump in people with Edema and Heart Failure, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The investigators hypothesize that leg edema will decrease rapidly when using the NormaTec pump, patients will lose weight, will feel better, will be less prone to infections in their legs and to congestion of the liver. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Edema, Heart Failure, Pulmonary Hypertension
- What is being tested?
- NormaTec Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to Jul 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemodynamically stable adult patients with pronounced leg edema from any etiology, on optimal medical therapy (such as diuretics, ACE-I or ARBs, digoxin).
- documentation of right heart failure by Echo or other modality (CT, MRI, right heart catheterization) and hemodynamic data from Echo is required and an elevated pulmonary artery pressure (> 35 mmHg) is expected in such cases.
Who cannot join
- patients in sepsis,
- hemodynamically unstable,
- during an acute attack of pulmonary edema,
- with renal failure (creatinine > 2 mg%),
- with DVT,
- psychiatric or noncompliant patients, and
- patients who will not sign the informed consent form will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
David S. Blondheim, MD contact
Israel1 site, 1 recruiting
- Recruiting
Hille Yaffe Medical Ceter
Hadera, Israel, 38100
David S Blondheim, MD, 97246304488
David S. Blondheim, MD
About this study
Official title: Effect of Normatec Pump for Relief of Leg Edema: Short- Intermediate- and Longer-term Outcomes
The investigators hypothesize that leg edema will decrease rapidly when using the NormaTec pump, patients will lose weight, will feel better, will be less prone to infections in their legs and to congestion of the liver. Temporary elevation of intravascular fluid volume by the mobilized edema fluid returned to the intravascular space by pumping may increase cardiac output and renal perfusion and in addition it may distend the right atrium and ventricle thus inducing BNP secretion. Both mechanisms may promote excess fluid removal by the kidneys.
- Conditions
- Edema, Heart Failure, Pulmonary Hypertension
- Being tested
- NormaTec Pump
- Keywords
- Edema, Heart failure, Pulmonary hypertension, Edema in legs
- Medical subject headings
- Edema, Heart Failure, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NormaTec PumpDevice
Normatec Pump
| Study group | Role | What they receive |
|---|---|---|
| Pumping group | Active comparator | Patients in this arm will get a pumping session 2-3 times a day . Receives: Device: NormaTec Pump |
| No pumping | Active comparator | These patients will not receive pumping but only classical treatment clinically indicated (diuretics, oxygen, Digoxin, Nitrates, ACE inhibitors etc, as necessary) Receives: Device: NormaTec Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
The weight loss during the pumping pariod is related to fluid loss from edematous legs.
Measured: 5 days
Secondary outcomes (1)
Leg circumference
The leg circumference will be measured before and after each pumping session to determine the effectiveness of the pumping.
Measured: 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112150
- Sponsor's protocol ID
- 0063-09-HYMC-CTIL
- Status last verified
- Apr 2010
- First submitted
- 12 Apr 2010
- Last updated
- 28 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Normatec Pump for Relief of Leg Edema: Short- Intermediate- and Longer-term Outcomes
- ClinicalTrials.gov ID
- NCT01112150
- Acronym / sponsor ID
- 0063-09-HYMC-CTIL
- Conditions
- Edema, Heart Failure, Pulmonary Hypertension
- Keywords
- Edema, Heart failure, Pulmonary hypertension, Edema in legs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 28 Apr 2010 (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 investigators hypothesize that leg edema will decrease rapidly when using the NormaTec pump, patients will lose weight, will feel better, will be less prone to infections in their legs and to congestion of the liver. Temporary elevation of intravascular fluid volume by the mobilized edema fluid returned to the intravascular space by pumping may increase cardiac output and renal perfusion and in addition it may distend the right atrium and ventricle thus inducing BNP secretion. Both mechanisms may promote excess fluid removal by the kidneys.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pumping group | Active comparator | Device: NormaTec PumpPatients in this arm will get a pumping session 2-3 times a day . |
| No pumping | Active comparator | Device: NormaTec PumpThese patients will not receive pumping but only classical treatment clinically indicated (diuretics, oxygen, Digoxin, Nitrates, ACE inhibitors etc, as necessary) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hemodynamically stable adult patients with pronounced leg edema from any etiology, on optimal medical therapy (such as diuretics, ACE-I or ARBs, digoxin).
- documentation of right heart failure by Echo or other modality (CT, MRI, right heart catheterization) and hemodynamic data from Echo is required and an elevated pulmonary artery pressure (> 35 mmHg) is expected in such cases.
Key exclusion criteria (7 listed)
- patients in sepsis,
- hemodynamically unstable,
- during an acute attack of pulmonary edema,
- with renal failure (creatinine > 2 mg%),
- with DVT,
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 |
|---|---|---|
| NormaTec PumpNormatec Pump | Device | No pumping, Pumping group |
Primary outcome
Weight Loss
Time frame: 5 days
The weight loss during the pumping pariod is related to fluid loss from edematous legs.
1 secondary outcome
Leg circumference
Time frame: 5 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
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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.
David S. Blondheim, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NormaTec Pump in people with Edema and Heart Failure, run by Hillel Yaffe Medical Center 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 2 inclusion and 7 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 28 Apr 2010. 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 David S. Blondheim, MD (97246304488), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: 5 days). 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 28 Apr 2010.