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Effect of Treating Sleep Disorder Breathing in Patients With Resistant Hypertension

Primary Purpose

Sleep Apnea, Hypertension

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Autotitrating Positive Airway Pressure (APAP)
Traditional Split Titration Polysomnogram
Sponsored by
Albert Einstein Healthcare Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea focused on measuring Sleep Disordered Breathing, Sleep Apnea, Hypertension, Continuous Positive Airway Pressure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Albert Einstein Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Ambulatory APAP and SMT

Titration Polysomnogram with CPAP and SMT

Arm Description

Subjects placed on the APAP machine

Subjects placed on CPAP machine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 2, 2009
Last Updated
January 25, 2012
Sponsor
Albert Einstein Healthcare Network
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1. Study Identification

Unique Protocol Identification Number
NCT00973531
Brief Title
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Withdrawn
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein Healthcare Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Ambulatory Autotitrating Positive Airway Pressure (APAP) plus Standard medical therapy OR 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Hypertension
Keywords
Sleep Disordered Breathing, Sleep Apnea, Hypertension, Continuous Positive Airway Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ambulatory APAP and SMT
Arm Type
Other
Arm Description
Subjects placed on the APAP machine
Arm Title
Titration Polysomnogram with CPAP and SMT
Arm Type
Other
Arm Description
Subjects placed on CPAP machine
Intervention Type
Device
Intervention Name(s)
Autotitrating Positive Airway Pressure (APAP)
Intervention Description
Then subjects will use Autotitrating Positive Airway Pressure machine for 90 days
Intervention Type
Device
Intervention Name(s)
Traditional Split Titration Polysomnogram
Intervention Description
Then subjects will use Continuous Positive Airway Pressure (CPAP) machine for 90 days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darshak Karia, MD
Organizational Affiliation
Albert Einstein Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States

12. IPD Sharing Statement

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Effect of Treating Sleep Disorder Breathing in Patients With Resistant Hypertension

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