Role of Enhanced External Counterpulsation (EECP) Therapy in Patients With Resistant Hypertension

NCT00953797 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-01-26

No results posted yet for this study

Summary

High Blood Pressure or Hypertension is one of the main causes of stroke, heart disease, heart attack and kidney disease. Traditionally physicians use diet and lifestyles change and medications to control patient's blood pressure. There are however, some patients whose blood pressures are difficult to control and their blood pressure remains elevated despite multiple medications. When blood pressure remains above goal (greater then 140/90 or greater then 130/80 mmHg in patients with diabetes or kidney disease) despite 3 or more blood pressure medications, the investigators call it "Resistant Hypertension".

Enhanced External Counterpulsation (EECP) is a new method of treatment currently used in people with heart disease and chest pain. EECP therapy uses three sets of balloon like cuffs that are wrapped to the calves, lower thighs, and upper thighs. These cuffs inflate and deflate with every heart beat, causing increased blood return to the heart and better blood flow. It has also been found to improve the function of endothelial cells, a type of cells that lines the wall of blood vessel through out the body which helps to regulate and maintain blood pressure. This leads us to believe that EECP therapy, although not used at present for treating patients with Resistant Hypertension, may be useful in decreasing blood pressure.

Conditions

Interventions

DEVICE

Enhanced External Counterpulsation

A non-invasive method currently used for the treatment of ischemic coronary disease. During EECP therapy three compressive pneumatic cuffs are wrapped around the calves, lower thighs, and upper thighs. The cuffs inflate sequentially during diastole causing retrograde aortic flow, and increased venous return. At end diastole, the cuffs rapidly deflate resulting in unloading of the left ventricle and a decrease in systolic blood pressure.

Sponsors & Collaborators

  • Albert Einstein Healthcare Network

    lead OTHER

Principal Investigators

  • Darshak H Karia, MD · Albert Einstein Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00953797 on ClinicalTrials.gov