Effect of Treating Sleep Disorder Breathing in Patients With Resistant Hypertension

Hypertension Clinical Trial

Official title:

Effect of Treating Sleep Disorder Breathing Therapy in Patients With Resistant Hypertension

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00973531
• Other study ID #: HN 4113
• Status: Withdrawn
• Phase: N/A
• First received: September 2, 2009
• Last updated: January 25, 2012
• Start date: May 2009
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Parasomnias
• Sleep Apnea
• Sleep Disorders

Intervention

Device:
• Autotitrating Positive Airway Pressure (APAP)
Then subjects will use Autotitrating Positive Airway Pressure machine for 90 days
• Traditional Split Titration Polysomnogram
Then subjects will use Continuous Positive Airway Pressure (CPAP) machine for 90 days

Locations

Country	Name	City	State
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No