Effect of Normatec Pump for Relief of Leg Edema in Patients With Right Heart Failure
Primary Purpose
Right Heart Failure, Cor Pulmonale
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
A mechanical compression pump
Sponsored by
About this trial
This is an interventional treatment trial for Right Heart Failure focused on measuring Edema, Right heart failure, Cor pulmonale, Pump, Leg compression
Eligibility Criteria
Inclusion Criteria:
- Hospitalized patients
- Adults
- Right heart failure secondary to pulmonary hypertension (cor pulmonale)
- Pronounced leg edema
Exclusion Criteria:
- 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
Sites / Locations
- Hille Yaffe Medical Ceter
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Patients will receive a NormaTec pump and perform active pumping twice daily during hospitalization and thereafter once daily in addition to routine medical therapy.
Routine medical treatment
Outcomes
Primary Outcome Measures
Patient weight
Secondary Outcome Measures
Leg circumference, Pulmonary pressures, Cardiac function
Full Information
NCT ID
NCT00834145
First Posted
February 2, 2009
Last Updated
February 2, 2009
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00834145
Brief Title
Effect of Normatec Pump for Relief of Leg Edema in Patients With Right Heart Failure
Official Title
Effect of Normatec Pump for Relief of Leg Edema in Patients With Right Heart Failure: Short- Intermediate- and Long-Term Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Heart Failure, Cor Pulmonale
Keywords
Edema, Right heart failure, Cor pulmonale, Pump, Leg compression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients will receive a NormaTec pump and perform active pumping twice daily during hospitalization and thereafter once daily in addition to routine medical therapy.
Arm Title
2
Arm Type
No Intervention
Arm Description
Routine medical treatment
Intervention Type
Device
Intervention Name(s)
A mechanical compression pump
Other Intervention Name(s)
NormaTec Pump
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient weight
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
Leg circumference, Pulmonary pressures, Cardiac function
Time Frame
3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospitalized patients
Adults
Right heart failure secondary to pulmonary hypertension (cor pulmonale)
Pronounced leg edema
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David S. Blondheim, MD
Phone
972-46304488
Email
blond@netvision.net.il
Facility Information:
Facility Name
Hille Yaffe Medical Ceter
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David S. Blondheim, MD
12. IPD Sharing Statement
Learn more about this trial
Effect of Normatec Pump for Relief of Leg Edema in Patients With Right Heart Failure
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