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Effect of Treating Sleep Disorder Breathing in Patients With Resistant Hypertension

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Darshak Karia, MD, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier:
NCT00973531
First received: September 2, 2009
Last updated: January 25, 2012
Last verified: January 2012

September 2, 2009
January 25, 2012
May 2009
October 2011   (final data collection date for primary outcome measure)
Noninferiority of the change from baseline to 90 day measurement in mean ambulatory 24-hour systolic ambulatory blood pressure in the Newer approach v/s Traditional Approach [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00973531 on ClinicalTrials.gov Archive Site
Noninferiority of the change from baseline to 90 day measurement in mean ambulatory 24-hour diastolic ambulatory blood pressure in the Newer approach v/s Traditional Approach [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Treating Sleep Disorder Breathing in Patients With Resistant Hypertension
Effect of Treating Sleep Disorder Breathing Therapy in Patients With Resistant Hypertension

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sleep Apnea
  • Hypertension
  • Device: Autotitrating Positive Airway Pressure (APAP)
    Then subjects will use Autotitrating Positive Airway Pressure machine for 90 days
  • Device: Traditional Split Titration Polysomnogram
    Then subjects will use Continuous Positive Airway Pressure (CPAP) machine for 90 days
  • Ambulatory APAP and SMT
    Subjects placed on the APAP machine
    Intervention: Device: Autotitrating Positive Airway Pressure (APAP)
  • Titration Polysomnogram with CPAP and SMT
    Subjects placed on CPAP machine
    Intervention: Device: Traditional Split Titration Polysomnogram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2011
October 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00973531
HN 4113
No
Darshak Karia, MD, Albert Einstein Healthcare Network
Albert Einstein Healthcare Network
Not Provided
Principal Investigator: Darshak Karia, MD Albert Einstein Medical Center
Albert Einstein Healthcare Network
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP