Role of Enhanced External Counterpulsation (EECP) Therapy in Patients With Resistant Hypertension (EECP)
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|ClinicalTrials.gov Identifier: NCT00953797|
Recruitment Status : Withdrawn
First Posted : August 6, 2009
Last Update Posted : January 26, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Device: Enhanced External Counterpulsation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of EECP Therapy in Patients With Resistant Hypertension|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
- 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.
- Change from baseline in mean ambulatory 24-hour systolic ambulatory blood pressure [ Time Frame: Approximately 50 days ]
- Change from baseline in mean ambulatory 24-hour diastolic ambulatory blood pressure [ Time Frame: Approximately 50 days ]
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 ClinicalTrials.gov identifier (NCT number): NCT00953797
|United States, Pennsylvania|
|Albert Einstein Medical Center|
|Philadelphia, Pennsylvania, United States, 19141|
|Principal Investigator:||Darshak H Karia, MD||Albert Einstein Medical Center|