Right Heart FailureNCT00834145
Effect of Normatec Pump for Relief of Leg Edema in Patients With Right Heart Failure
A study testing A mechanical compression pump in people with Right Heart Failure and Cor Pulmonale, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Mobilization of fluid from the legs with the Normatec pump in patients with right heart failure, may empty the "reservoir" in the legs from excessive fluid, enabling fluid overload to collect there rather than in the liver or in other third spaces. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Right Heart Failure, Cor Pulmonale
- What is being tested?
- A mechanical compression pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2009to Dec 2009
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients
- Adults
- Right heart failure secondary to pulmonary hypertension (cor pulmonale)
- Pronounced leg edema
Who cannot join
- Patients in sepsis
- Hemodynamically unstable
- Renal failure (creatinine >2 mg%)
- Deep vein thrombosis
- Pregnancy
- Psychiatric/noncompliant patients
- Patients who will not sign the informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Normatec Pump for Relief of Leg Edema in Patients With Right Heart Failure: Short- Intermediate- and Long-Term Outcomes
Mobilization of fluid from the legs with the Normatec pump in patients with right heart failure, may empty the "reservoir" in the legs from excessive fluid, enabling fluid overload to collect there rather than in the liver or in other third spaces. Thus, we hypothesize that patients will lose weight, feel better, look better, be less prone to infections in their legs and to congestion of the liver.
Read the detailed description
The protocol will be divided into 2 parts:
- The initial pumping phase will be an in-hospital study, short term study. Patients will be randomly assigned to conventional/conservative treatment or to pump therapy. Within 24 hours of admission patients assigned to pump therapy will be recruited for the study and will begin therapy according to the protocol outlined in the table below. These patients will not be given diuretics unless required to because of shortness of breath with suspected left heart failure. Individualized programs regarding pumping frequency and pump parameters will be set for each patient and will be adjusted during the first few days and maintained throughout the study unless there is a reason to modify them. Data on both the conventional/conservative and the pump arms of the study will be collected at similar intervals. The duration of the in-hospital period will not be extended because of the study and is expected to be 3-7 days.
- An intermediate-term study in which the patients from the phase 1 study will be ambulatory. During this phase of the study the effect of continuous maintenance and optimization will be monitored. Patients will come to the hospital for their pumping session at which time the protocol tests will be performed. Patients that were assigned to the conventional/conservative arm in phase 1 will be examined as per protocol at 1, 2 and 3 weeks after admission but BNP levels will be repeated only after the 3rd week.
- At 3 and 6 months after admission, the "long term" phase of the study, a systematic investigation regarding repeat hospitalizations and their causes will be carried out by telephone interview and by a review of admission data from hospital records.
- Conditions
- Right Heart Failure, Cor Pulmonale
- Being tested
- A mechanical compression pump
- Keywords
- Edema, Right heart failure, Cor pulmonale, Pump, Leg compression
- Medical subject headings
- Heart Failure, Pulmonary Heart Disease, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A mechanical compression pumpDevice
Also called NormaTec Pump
Patients in the experimental arm will receive a NormaTec pump which will be used twice daily during hospitalization and once daily on an ambulatory basis. A cuff is placed over the leg and a pneumatic system automatically compresses the leg according to predefined parameters of pressure, time etc.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients will receive a NormaTec pump and perform active pumping twice daily during hospitalization and thereafter once daily in addition to routine medical therapy. Receives: Device: A mechanical compression pump |
| 2 | No intervention | Routine medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient weight
Measured: 3 and 6 months
Secondary outcomes (1)
Leg circumference, Pulmonary pressures, Cardiac function
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834145
- Sponsor's protocol ID
- 32/2008
- Status last verified
- Feb 2009
- First submitted
- 2 Feb 2009
- Last updated
- 3 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Normatec Pump for Relief of Leg Edema in Patients With Right Heart Failure: Short- Intermediate- and Long-Term Outcomes
- ClinicalTrials.gov ID
- NCT00834145
- Acronym / sponsor ID
- 32/2008
- Conditions
- Right Heart Failure, Cor Pulmonale
- Keywords
- Edema, Right heart failure, Cor pulmonale, Pump, Leg compression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 3 Feb 2009 (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.
Mobilization of fluid from the legs with the Normatec pump in patients with right heart failure, may empty the "reservoir" in the legs from excessive fluid, enabling fluid overload to collect there rather than in the liver or in other third spaces. Thus, we hypothesize that patients will lose weight, feel better, look better, be less prone to infections in their legs and to congestion of the liver.
Detailed description
The protocol will be divided into 2 parts:
- The initial pumping phase will be an in-hospital study, short term study. Patients will be randomly assigned to conventional/conservative treatment or to pump therapy. Within 24 hours of admission patients assigned to pump therapy will be recruited for the study and will begin therapy according to the protocol outlined in the table below. These patients will not be given diuretics unless required to because of shortness of breath with suspected left heart failure. Individualized programs regarding pumping frequency and pump parameters will be set for each patient and will be adjusted during the first few days and maintained throughout the study unless there is a reason to modify them. Data on both the conventional/conservative and the pump arms of the study will be collected at similar intervals. The duration of the in-hospital period will not be extended because of the study and is expected to be 3-7 days.
- An intermediate-term study in which the patients from the phase 1 study will be ambulatory. During this phase of the study the effect of continuous maintenance and optimization will be monitored. Patients will come to the hospital for their pumping session at which time the protocol tests will be performed. Patients that were assigned to the conventional/conservative arm in phase 1 will be examined as per protocol at 1, 2 and 3 weeks after admission but BNP levels will be repeated only after the 3rd week.
- At 3 and 6 months after admission, the "long term" phase of the study, a systematic investigation regarding repeat hospitalizations and their causes will be carried out by telephone interview and by a review of admission data from hospital records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: A mechanical compression pumpPatients will receive a NormaTec pump and perform active pumping twice daily during hospitalization and thereafter once daily in addition to routine medical therapy. |
| 2 | No intervention | –Routine medical treatment |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized patients
- Adults
- Right heart failure secondary to pulmonary hypertension (cor pulmonale)
- Pronounced leg edema
Key exclusion criteria (7 listed)
- Patients in sepsis
- Hemodynamically unstable
- Renal failure (creatinine >2 mg%)
- Deep vein thrombosis
- Pregnancy
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 |
|---|---|---|
| A mechanical compression pumpAlso: NormaTec PumpPatients in the experimental arm will receive a NormaTec pump which will be used twice daily during hospitalization and once daily on an ambulatory basis. A cuff is placed over the leg and a pneumatic system automatically compresses the leg according to predefined parameters of pressure, time etc. | Device | 1 |
Primary outcome
Patient weight
Time frame: 3 and 6 months
1 secondary outcome
Leg circumference, Pulmonary pressures, Cardiac function
Time frame: 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A mechanical compression pump in people with Right Heart Failure and Cor Pulmonale, 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 4 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 3 Feb 2009. 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 (972-46304488, blond@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient weight (time frame: 3 and 6 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 3 Feb 2009.