Effect of Treating Sleep Disorder Breathing in Patients With Resistant Hypertension

NCT ID: NCT00973531

Last Updated: 2012-01-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-10-31

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.

Conditions

Sleep Apnea; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ambulatory APAP and SMT

Subjects placed on the APAP machine

Group Type: OTHER

Autotitrating Positive Airway Pressure (APAP)

Intervention Type: DEVICE

Then subjects will use Autotitrating Positive Airway Pressure machine for 90 days

Titration Polysomnogram with CPAP and SMT

Subjects placed on CPAP machine

Group Type: OTHER

Traditional Split Titration Polysomnogram

Intervention Type: DEVICE

Then subjects will use Continuous Positive Airway Pressure (CPAP) machine for 90 days

Interventions

Autotitrating Positive Airway Pressure (APAP)

Then subjects will use Autotitrating Positive Airway Pressure machine for 90 days

Intervention Type: DEVICE

Traditional Split Titration Polysomnogram

Then subjects will use Continuous Positive Airway Pressure (CPAP) machine for 90 days

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albert Einstein Healthcare Network

OTHER

Sponsor Role: lead

Responsible Party

Darshak Karia, MD

Albert Einstein Healthcare Network

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Darshak Karia, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein Medical Center

Locations

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

HN 4113

Identifier Type: -

Identifier Source: org_study_id