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Race And CPAP Effectiveness (RACE)

This study is currently recruiting participants.
Verified September 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT01960465
First Posted: October 10, 2013
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
September 9, 2013
October 10, 2013
September 11, 2017
January 5, 2015
June 30, 2018   (Final data collection date for primary outcome measure)
24 hour ambulatory blood pressure [ Time Frame: 3 months ]
Mean systolic and diastolic blood pressure measured over 24 hours with ambulatory monitor (Spacelabs).
Same as current
Complete list of historical versions of study NCT01960465 on ClinicalTrials.gov Archive Site
  • Central aortic blood pressure [ Time Frame: 3 months ]
    Central aortic blood pressure measured noninvasively with a cuff (SphygmoCor XCEL)
  • Urinary sympathetic activity (catecholamines) and oxidative stress (8-isoprostane) [ Time Frame: 3 months ]
    Urine samples from participants over 24 hours will be analyzed for catecholamines and overnight sample will be partitioned for measurement of oxidative stress.
  • Central aortic blood pressure [ Time Frame: 3 months ]
    Central aortic blood pressure measured noninvasively with a cuff (Sphygmocor exel).
  • Urinary sympathetic activity (catecholamines) and oxidative stress (8-isoprostane) [ Time Frame: 3 months ]
    Urine samples from participants over 24 hours will be analyzed for catecholamines and overnight sample will be partitioned for measurement of oxidative stress.
Not Provided
Not Provided
 
Race And CPAP Effectiveness
Targeted Treatment of Obstructive Sleep Apnea to Reduce Cardiovascular Disparity
Obstructive sleep apnea (OSA) is a major public health problem in the U.S. and more than 35% of Veterans are at high risk for OSA. OSA is associated with progression of hypertension, an important health problem in Veterans. African Americans with OSA are at increased risk for poorly controlled hypertension and its health consequences. Implementing a care plan to increase the percentage of Veterans in whom blood pressure goals are achieved has been prioritized by Veterans Administration hospitals. Recent studies show that hypertension control can be improved with continuous positive airway pressure (CPAP) treatment of OSA. The aim of this proposal is to examine and compare the effects of CPAP treatment on 24-hour arterial blood pressure and central aortic blood pressure (measured non-invasively with a cuff on the upper arm) in African American and other Veterans.
Obstructive Sleep Apnea (OSA) and hypertension are both common and severe problems in African American individuals (as noted in the International Society on Hypertension in Blacks consensus statement). CPAP treatment of OSA is effective in controlling hypertension in patients with OSA, but has not been studied in African Americans, a high-risk population with potentially large health gains. This is an area of significance because poorly controlled hypertension leads to progression of cardiovascular disease (CVD) and morbidity in this population. By identifying CPAP treatment-response and relevant moderators of this response in African Americans with hypertension and OSA, targeted treatment of OSA can be implemented, reducing the excess burden of CVD. The investigators will determine the relative magnitude of hypertension response to CPAP treatment (ambulatory blood pressure and central aortic blood pressure) in 220 African American and Veterans of other race(s) with hypertension and newly diagnosed OSA (specific aim 1). The investigators will measure changes in pathogenic biomarkers (urinary cumulative sympathetic nervous system activity and oxidative stress) that are responsive to CPAP treatment in addition to hypertension assessments. Further, the investigators will examine the role of excessive daytime sleepiness (EDS), a potentially important moderator of treatment response, in these two patient populations (specific aim 2). Finally, the investigators will adjust the outcomes assessment for the anticipated biological heterogeneity among self-identified African Americans by measuring genetic ancestry (exploratory aim). This award will provide the foundation for the goals of this research program to reduce CVD disparity in diverse populations with targeted treatment of OSA.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Sleep Apnea Syndromes
Device: Continuous positive airway pressure
A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.
Other Name: CPAP
  • Experimental: African Americans
    160 Self identified African American
    Intervention: Device: Continuous positive airway pressure
  • Active Comparator: non African Americans
    and 60 Other race (non African Americans) Veterans will be enrolled.
    Intervention: Device: Continuous positive airway pressure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
December 30, 2018
June 30, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Self-identified African American and other Veterans (of self-identified race other than African American)
  • Age: 30-70 years
  • Hypertension
  • Apnea hypopnea index (AHI) 15/hour on home sleep apnea test

Exclusion Criteria:

  • Past/current treatment of Obstructive Sleep Apnea or other primary sleep disorders
  • Active uncontrolled medical conditions
  • Shift work in past 6 months
  • Current drug use
  • Pregnancy
Sexes Eligible for Study: All
30 Years to 70 Years   (Adult, Senior)
No
Contact: Bharati Prasad, MD bharati.prasad@va.gov
Contact: Israel Rubinstein, MD (312) 569-6129 Israel.Rubinstein@va.gov
United States
 
 
NCT01960465
CLIN-022-13S
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Bharati Prasad, MD Jesse Brown VA Medical Center, Chicago, IL
VA Office of Research and Development
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP