Clinical trial NCT00973531: Effect of Treating Sleep Disorder Breathing in Patients With Resistant Hypertension
Official title: Effect of Treating Sleep Disorder Breathing Therapy in Patients With Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sleep Apnea
Hypertension
Keywords: Sleep Disordered Breathing
Sleep Apnea
Hypertension
Continuous Positive Airway Pressure
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
First posted: 2009-09-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 pressure in patients with Resistant Hypertension.

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 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.

Eligibility 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)

Primary outcomes:
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
timeFrame: 90 days
Secondary outcomes:
measure: 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
timeFrame: 90 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
Study officials:
affiliation: Albert Einstein Medical Center
name: Darshak Karia, MD
role: PRINCIPAL_INVESTIGATOR
References: