Effect of Treating Sleep Disorder Breathing in Patients With Resistant Hypertension

Withdrawn before enrolling · Not applicable

Conditions studied: Sleep Apnea, Hypertension

In brief

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 pressure in patients with Resistant Hypertension.

Key facts

Study ID

NCT00973531

Run by

Albert Einstein Healthcare Network

People needed

0

Starts

2009-05-01

Expected to finish

2011-10-01

Last updated by the study team

2012-01-26

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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 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

You may not qualify if…

• 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)

Where it is running

• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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