Status:
WITHDRAWN
Effect of Treating Sleep Disorder Breathing in Patients With Resistant Hypertension
Lead Sponsor:
Albert Einstein Healthcare Network
Conditions:
Sleep Apnea
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The investigators would like to investigate the effects of treating sleep apnea with a positive airway pressure device, either continuous (titrated) versus auto titrated on the control of blood pressu...
Detailed Description
One of the major cause and contributor to stroke, myocardial infarction, heart disease, and kidney disease is high blood pressure. Traditional approaches to control of hypertension (HTN) have mostly i...
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 24 hour systolic blood pressure ≥130 mmHg
- All other subjects must have a mean 24 hour systolic blood pressure ≥140 mmHg
- Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, preferably including a diuretic
Exclusion
- Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
- Known Sleep apnea
- Subjects who perform alternating shift or night work
- 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
- Subjects 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
NCT00973531
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