View Clinical Trial (Medical Research Study)

Effect of Treating Sleep Disorder Breathing in Patients With Resistant Hypertension - NCT00973531-19141B(Clinical Trial 319938)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Philadelphia
State:  
PA
Zip Code: 19141
Conditions: Sleep Apnea - Hypertension
Purpose: 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.
Study summary: 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 included pharmaceuticals targeting different mechanisms that contribute to HTN. However, adequate control of Blood pressure continues to remain a major problem. Sleep Apnea is currently being recognized as a modifiable risk factor for resistant HTN. Sleep disordered breathing represents states of increased sympathetic drive and vagal tone withdrawal, along with significant episodic hypoxia. There is increasing evidence that sleep apnea is highly prevalent in subjects with hypertension and may be a frequent cause of drug-resistant hypertension. We propose that we compare strategies for treating subjects with Resistant Hypertension who have SDB as detected by ambulatory multi somnogram and treat subjects using: 1. Ambulatory Autotitrating Positive Airway Pressure (APAP) plus Standard medical therapy OR 2. Traditional Polysomnogram and Traditional PSG guided titration of Continuous Positive Airway Pressure (CPAP) plus Standard medical therapy Our hypothesis is that in subjects with Resistant HTN, who have SDB, using the treatment approach of ambulatory multisomnography for testing and then treating with APAP will be noninferior to the traditional polysomnography plus CPAP approach in the amount of reduction of mean systolic and diastolic 24 hour ambulatory blood pressure, when treated for 90 days.
Criteria: Inclusion Criteria: - 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 Criteria: - 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)
Study is available at: Albert Einstein Medical Center
Philadelphia, PA 19141
United States

Primary Contact:
Darshak H Karia, MD
Email: kariad@einstein.edu
Phone: 215-456-3291

Secondary Contact:
Darshak H Karia, MD
Email: kariad@einstein.edu
Phone: 215-456-3291
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.