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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Sleep Apnea
Hypertension
Device: Autotitrating Positive Airway Pressure (APAP)
Device: Traditional Split Titration Polysomnogram

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Treating Sleep Disorder Breathing Therapy in Patients With Resistant Hypertension

Resource links provided by NLM:


Further study details as provided by Albert Einstein Healthcare Network:

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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]

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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973531

Locations
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Albert Einstein Healthcare Network
Investigators
Principal Investigator: Darshak Karia, MD Albert Einstein Medical Center
  More Information

No publications provided

Responsible Party: Darshak Karia, MD, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT00973531     History of Changes
Other Study ID Numbers: HN 4113
Study First Received: September 2, 2009
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein Healthcare Network:
Sleep Disordered Breathing
Sleep Apnea
Hypertension
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Apnea
Respiratory Aspiration
Hypertension
Sleep Apnea Syndromes
Sleep Disorders
Parasomnias
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014