The Effects of Obstructive Sleep Apnea and Its Intervention on Coronary Heart Disease

NCT02059993 | Completed Results DMC

• 1 other identifier: SF2009-2012
• Study Type: interventional
• Target: 83
• Locations: 0 countries
• Sites: N/A

Brief Summary

Obstructive sleep apnea(OSA) is an important identifiable cause of hypertension. Previous study has suggested that OSA significantly increases cardiovascular morbidity and mortality, especially in patients with pre-existing cardiovascular disease.The standardized treatment of moderate/severe OSA is continuous positive airway pressure (CPAP). Most of short-term trials indicated that CPAP treatment reduced BP in patients with OSA. But relevant studies have a relative short duration with only but few more than one year. In our opinion, they are not sufficient to detect the real effect of CPAP on reduction in BP. Besides, the impact of OSA on metabolic disorder is still unclear.We hypothesized that long-term CPAP treatment could reduce blood pressure and improve metabolic disorder in patients with coronary heart disease (CHD)and OSA.

Conditions

Hypertension; Metabolic Disorder

Keywords

continuous positive airway pressure; hypertension; coronary heart disease; metabolic disorder; obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment

  baseline and follow-up at 36 months

Secondary Outcomes (1)

• Change in Epworth Sleepiness Scale (ESS)

  baseline，end of study ( up to 54 months)

Other Outcomes (1)

• Cardiovascular and Cerebrovascular Events

  Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month

Study Arms (2)

continuous positive airway pressure

OTHER

mean continuous positive airway pressure use was at least 4 hours per night; continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure

Device: continuous positive airway pressure

Control

NO INTERVENTION

The control subjects received standardised anti-hypertension medications according to the current guildline.

Interventions

continuous positive airway pressure DEVICE

mean continuous positive airway pressure use was at least 4 hours per night;continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure

continuous positive airway pressure

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women, aged 45 to 75 years old
• verified diagnosis of hypertension by medical history or receiving antihypertensive drugs
• established diagnosis of CHD
• at least 3-month optimal treatment for hypertension
• moderate or severe OSA

You may not qualify if:

• if they had secondary hypertension
• central sleep apneas
• history of significant chronic renal, or hepatic failure or severe pulmonary disease
• diagnosed with malignant cancer with a life expectancy of less than 2years
• regular use of medications that can affect BP(including corticosteroids or sedative drugs)
• severe psychiatric disease
• sustained excessive alcohol use
• current use of CPAP treatment for OSA or pharyngeal surgery for OSA
• New York Heart Association Class III-IV degree
• declined to participate or were unable to give informed consent

Sponsors & Collaborators

• Chinese Pulmonary Vascular Disease Research Group: lead

Related Publications (1)

• Huang Z, Liu Z, Luo Q, Zhao Q, Zhao Z, Ma X, Liu W, Yang D. Long-term effects of continuous positive airway pressure on blood pressure and prognosis in hypertensive patients with coronary heart disease and obstructive sleep apnea: a randomized controlled trial. Am J Hypertens. 2015 Mar;28(3):300-6. doi: 10.1093/ajh/hpu147. Epub 2014 Aug 14.

  PMID: 25125635 DERIVED

MeSH Terms

Conditions

Hypertension; Metabolic Diseases; Coronary Disease; Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Limitations and Caveats

First, the sample size was relatively small. Second, this was a nondouble-blind study. Third, we did not use 24-hour ambulatory BP to monitor changes in BP and could not evaluate the nighttime BP.

Results Point of Contact

• Title: Zhihong Liu
• Organization: State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

zhihongliufuwai@163.com

+86-01088398196

Study Officials

• Zhihong Liu, MD，PhD

  Fuwai Hospital, National Center for Cardiovascular Diseases

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2014
• First Posted: February 11, 2014
• Study Start: January 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 16, 2020
• Results First Posted: April 9, 2015

Record last verified: 2020-07