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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chinese Pulmonary Vascular Disease Research Group
ClinicalTrials.gov Identifier:
NCT02059993
First received: February 9, 2014
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Hypertension
Metabolic Disorder
Device: continuous positive airway pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Obstructive Sleep Apnea and Its Intervention on Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by Chinese Pulmonary Vascular Disease Research Group:

Primary Outcome Measures:
  • Change in Blood Pressure [ Time Frame: Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Glucose and Lipid metabolism [ Time Frame: Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month ] [ Designated as safety issue: No ]
  • Change in epworth sleepiness scale (ESS) [ Time Frame: 1 month,3 month,6 month,12 month,18 month,24 month,30 month,36 month ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • cardiovascular and cerebrovascular events [ Time Frame: Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: January 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
continuous positive airway pressure
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
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
No Intervention: No treatment

Detailed Description:

Obstructive sleep apnea (OSA) is a common disorder characterized by repetitive partial (hypopnea) or complete (apnea) occlusion of the upper airway during sleep caused by collapse of the pharyngeal airway, resulting in sleep fragmentation and oxyhemoglobin desaturation. Kiely and colleague's study showed that over 20% of hypertensive patients exhibit OSA, whereas prevalence of hypertension in the setting of OSA exceeds 50%. One study confirmed that OSA is an important identifiable cause of hypertension. OSA is considered as one of the most common risk factors of resistant hypertension. Previous study has suggested that OSA significantly increases cardiovascular morbidity and mortality, especially in patients with pre-existing cardiovascular disease. Several studies confirmed that CPAP reduced systolic blood pressure (SBP) and diastolic blood pressure (DBP) in patients with OSA. Additionally, some papers reported that there was a protective effect of CPAP therapy against death from cardiovascular disease in patients with severe OSA. Other researches regarding the antihypertensive effect of CPAP therapy, however, showed that CPAP had no antihypertensive effect. 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. According to our knowledge, there is no report about long-term effect of CPAP on BP in hypertensive patients with coronary revascularization (CRV) and OSA under conventional antihypertensive medications. Therefore, we conducted a long-term, prospective controlled study to investigate the effects of CPAP on BP, metabolic disorder, clinical symptoms, cardiovascular and cerebrovascular events in patients with CHD and OSA on conventional treatment.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059993

Sponsors and Collaborators
Chinese Pulmonary Vascular Disease Research Group
Investigators
Study Chair: Zhihong Liu, MD,PhD Fuwai Hospital, National Center for Cardiovascular Diseases
  More Information

No publications provided

Responsible Party: Chinese Pulmonary Vascular Disease Research Group
ClinicalTrials.gov Identifier: NCT02059993     History of Changes
Other Study ID Numbers: SF2009-2012
Study First Received: February 9, 2014
Last Updated: February 11, 2014
Health Authority: China: Ministry of Health

Keywords provided by Chinese Pulmonary Vascular Disease Research Group:
continuous positive airway pressure
hypertension
coronary heart disease
metabolic disorder
obstructive sleep apnea

Additional relevant MeSH terms:
Apnea
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hypertension
Metabolic Diseases
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014