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.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension; Sleep Apnea
• Intervention / Treatment: Device: Autotitrating Positive Airway Pressure (APAP); Device: Traditional Split Titration Polysomnogram

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ambulatory APAP and SMT; Subjects placed on the APAP machine	Device: Autotitrating Positive Airway Pressure (APAP); Then subjects will use Autotitrating Positive Airway Pressure machine for 90 days
Other: Titration Polysomnogram with CPAP and SMT; Subjects placed on CPAP machine	Device: Traditional Split Titration Polysomnogram; Then subjects will use Continuous Positive Airway Pressure (CPAP) machine for 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Albert Einstein Healthcare Network
• Investigators: Principal Investigator: Darshak Karia, MD, Albert Einstein Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: September 2, 2009
• First Submitted That Met QC Criteria: September 8, 2009
• First Posted (Estimate): September 9, 2009

Study Record Updates

• Last Update Posted (Estimate): January 26, 2012
• Last Update Submitted That Met QC Criteria: January 25, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Hypertension; Continuous Positive Airway Pressure; Sleep Apnea; Sleep Disordered Breathing
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Sleep Apnea Syndromes; Hypertension; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: HN 4113