NCT00834145

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
26 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 3, 2009

Status Verified

February 1, 2009

Enrollment Period

9 months

First QC Date

February 2, 2009

Last Update Submit

February 2, 2009

Conditions

Right Heart FailureCor Pulmonale

Keywords

EdemaRight heart failureCor pulmonalePumpLeg compression

Outcome Measures

Primary Outcomes (1)

  • Patient weight

    3 and 6 months

Secondary Outcomes (1)

  • Leg circumference, Pulmonary pressures, Cardiac function

    3 and 6 months

Study Arms (2)

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.

Device: A mechanical compression pump

2

NO INTERVENTION

Routine medical treatment

Interventions

A mechanical compression pumpDEVICE

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.

Also known as: NormaTec Pump
1

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized patients
  • Adults
  • Right heart failure secondary to pulmonary hypertension (cor pulmonale)
  • Pronounced leg edema

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hille Yaffe Medical Ceter

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Heart FailurePulmonary Heart DiseaseEdema

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

David S. Blondheim, MD

CONTACT

972-46304488blond@netvision.net.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 3, 2009

Record last verified: 2009-02

Locations

IL(1)