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

NCT00953797 | Withdrawn

• 1 other identifier: HN4112
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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

Hypertension

Keywords

Resistant Hypertension; Endothelial dysfunction; Enhanced External Counterpulsation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean ambulatory 24-hour systolic ambulatory blood pressure

  Approximately 50 days

Secondary Outcomes (1)

• Change from baseline in mean ambulatory 24-hour diastolic ambulatory blood pressure

  Approximately 50 days

Interventions

Enhanced External Counterpulsation DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Darshak H Karia, MD

  Albert Einstein Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Heart Failure Services

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 6, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 26, 2012

Record last verified: 2012-01

Locations

US (1)