Status:
WITHDRAWN
Role of Enhanced External Counterpulsation (EECP) Therapy in Patients With Resistant Hypertension
Lead Sponsor:
Albert Einstein Healthcare Network
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 cont...
Detailed Description
Hypertension is a major cause and contributor to stroke, heart and kidney disease and could worsen the progression as well. Despite major reductions in age-adjusted death rates from coronary heart dis...
Eligibility Criteria
Inclusion
- Subjects who are competent to provide written consent
- Aged 18 to 80 years
- Deemed to be compliant with anti-hypertension medication therapy.
- Subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmHg
- All other subjects must have a mean systolic blood pressure ≥140 mmHg
- Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
- Female subjects of non-childbearing potential (i.e., post-menopausal for at least 2 years; surgically sterile)
- Deemed to be compliant with anti-hypertension medication therapy
Exclusion
- Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
- Known Sleep apnea
- Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening
- Have hypertension secondary to an identifiable and treatable cause other than sleep apnea
- Acute coronary syndrome \< 6 weeks prior to enrollment
- Non-bypassable left main coronary with a luminal stenosis ≥ 50%
- CABG \< 3 months or PCI \< 6 months prior to enrollment
- Cardiac catheterization \< 2 weeks prior to enrollment
- Arrhythmias that would significantly interfere with the triggering of the EECP device.
- Clinically significant valvular heart disease
- Acute myocarditis
- ICD if it has been triggered \< 3 months prior to enrollment
- History of deep vein thrombosis, phlebitis, stasis ulcer, pulmonary embolism, and/or aortic aneurysm
- INR ≥ 2.5
- Patients taking over the counter medications that can raise blood pressure, such as
- Non narcotic analgesics
- Non steroidal anti-inflammatory agents, including aspirin, Selective COX-2 inhibitors
- Sympathomimetic agents (decongestants, diet pills, cocaine)
- Stimulants (methylphenidate, dexmethylphenidate, dextroamphetamine, amphetamine, methamphetamine, modafinil)
- Alcohol
- Oral contraceptives
- Cyclosporine
- Erythropoietin
- Natural licorice
- Herbal compounds (ephedra or ma huang)
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00953797
Start Date
May 1 2009
End Date
October 1 2011
Last Update
January 26 2012
Active Locations (1)
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1
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141