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

Right Heart Failure Clinical Trial

Official title:

Effect of Normatec Pump for Relief of Leg Edema in Patients With Right Heart Failure: Short- Intermediate- and Long-Term Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00834145
• Other study ID #: 32/2008
• Status: Not yet recruiting
• Phase: N/A
• First received: February 2, 2009
• Last updated: February 2, 2009
• Start date: March 2009
• Est. completion date: December 2009

Study information

• Verified date: February 2009
• Source: Hillel Yaffe Medical Center
• Contact: David S. Blondheim, MD
• Phone: 972-46304488
• Email: blond[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cor Pulmonale
• Heart Failure
• Pulmonary Heart Disease
• Right Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Israel	Hille Yaffe Medical Ceter	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient weight		3 and 6 months	No
Secondary	Leg circumference, Pulmonary pressures, Cardiac function		3 and 6 months	No