Effect of Treating Sleep Disorder Breathing in Patients With Resistant Hypertension

Not Applicable

Withdrawn

• Conditions: Sleep Apnea; Hypertension
• Interventions: Device: Autotitrating Positive Airway Pressure (APAP); Device: Traditional Split Titration Polysomnogram

• Registration Number: NCT00973531
• Lead Sponsor: Albert Einstein Healthcare Network

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-08
• Study First Posted: 2009-09-09
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-25
• Last Update Posted: 2012-01-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambulatory APAP and SMT	Autotitrating Positive Airway Pressure (APAP)	Subjects placed on the APAP machine
Titration Polysomnogram with CPAP and SMT	Traditional Split Titration Polysomnogram	Subjects placed on CPAP machine

Primary Outcome Measures

Name	Time	Method
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	90 days

Secondary Outcome Measures

Name	Time	Method
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	90 days

Trial Locations

Locations (1)

Albert Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States