Effect of Normatec Pump for Relief of Leg Edema in Patients With Right Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00834145
Recruitment Status : Unknown
Verified February 2009 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 3, 2009
Last Update Posted : February 3, 2009
Information provided by:
Hillel Yaffe Medical Center

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.

Condition or disease Intervention/treatment
Right Heart Failure Cor Pulmonale Device: A mechanical compression pump

Detailed Description:

The protocol will be divided into 2 parts:

  1. 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.

  2. 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.
  3. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Normatec Pump for Relief of Leg Edema in Patients With Right Heart Failure: Short- Intermediate- and Long-Term Outcomes
Study Start Date : March 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Patients will receive a NormaTec pump and perform active pumping twice daily during hospitalization and thereafter once daily in addition to routine medical therapy.
Device: A mechanical compression 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.
Other Name: NormaTec Pump
No Intervention: 2
Routine medical treatment

Primary Outcome Measures :
  1. Patient weight [ Time Frame: 3 and 6 months ]

Secondary Outcome Measures :
  1. Leg circumference, Pulmonary pressures, Cardiac function [ Time Frame: 3 and 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00834145

Contact: David S. Blondheim, MD 972-46304488

Hille Yaffe Medical Ceter Not yet recruiting
Hadera, Israel, 38100
Principal Investigator: David S. Blondheim, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center

Responsible Party: David Blondheim, M.D., Hillel Yaffe Medical Center Identifier: NCT00834145     History of Changes
Other Study ID Numbers: 32/2008
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: February 3, 2009
Last Verified: February 2009

Keywords provided by Hillel Yaffe Medical Center:
Right heart failure
Cor pulmonale
Leg compression

Additional relevant MeSH terms:
Heart Failure
Pulmonary Heart Disease
Heart Diseases
Cardiovascular Diseases