Effect of Normatec Pump for Relief of Leg Edema

Heart Failure Clinical Trial

Official title:

Effect of Normatec Pump for Relief of Leg Edema: Short- Intermediate- and Longer-term Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01112150
• Other study ID #: 0063-09-HYMC-CTIL
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2010
• Last updated: April 27, 2010
• Start date: April 2010
• Est. completion date: July 2012

Study information

• Verified date: April 2010
• Source: Hillel Yaffe Medical Center
• Contact: David S. Blondheim, MD
• Phone: 97246304488
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that leg edema will decrease rapidly when using the NormaTec pump, patients will lose weight, will feel better, will be less prone to infections in their legs and to congestion of the liver. Temporary elevation of intravascular fluid volume by the mobilized edema fluid returned to the intravascular space by pumping may increase cardiac output and renal perfusion and in addition it may distend the right atrium and ventricle thus inducing BNP secretion. Both mechanisms may promote excess fluid removal by the kidneys.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• hemodynamically stable adult patients with pronounced leg edema from any etiology, on optimal medical therapy (such as diuretics, ACE-I or ARBs, digoxin).

• documentation of right heart failure by Echo or other modality (CT, MRI, right heart catheterization) and hemodynamic data from Echo is required and an elevated pulmonary artery pressure (> 35 mmHg) is expected in such cases.

Exclusion Criteria:

• patients in sepsis,

• hemodynamically unstable,

• during an acute attack of pulmonary edema,

• with renal failure (creatinine > 2 mg%),

• with DVT,

• psychiatric or noncompliant patients, and

• patients who will not sign the informed consent form will be excluded from the study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Edema
• Heart Failure
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Device:
• NormaTec Pump
Normatec Pump

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	Weight Loss	The weight loss during the pumping pariod is related to fluid loss from edematous legs.	5 days	No
Secondary	Leg circumference	The leg circumference will be measured before and after each pumping session to determine the effectiveness of the pumping.	5 Days	No