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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control | No Intervention | The control subjects received standardised anti-hypertension medications according to the current guildline. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment | baseline and follow-up at 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Epworth Sleepiness Scale (ESS) | The epworth sleepiness scale（ESS） measures a person's general level of daytime sleepiness, or their average sleep propensity in daily life (ASP). It is a simple questionnaire based on retrospective reports of the likelihood of dozing off or falling asleep in a variety of different situations. The ESS is the most commonly used method for measuring a person's ASP.The ESS ranges from 0-24, higher scores indicate more severe daytime sleepiness. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular and Cerebrovascular Events | Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhihong Liu, MD，PhD | Fuwai Hospital, National Center for Cardiovascular Diseases | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25125635 | Derived | 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. |
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A total of 243 patients were screened between January 2009 and June 2012. Out of 97 (39.9%) patients diagnosed with obstructive sleep apnea (OSA), 5 subjects declined to participate in the study, and 9 subjects were excluded because of the following: apnea-hypopnea index (AHI) <15 (n = 8 patients) and severe heart failure (n = 1 patient).
We recruited consecutive patients from outpatient and inpatient departments of Fuwai Hospital from January 2009 to June 2012. Patients were randomly assigned to either continuous positive airway pressure (CPAP) group or no CPAP therapy (control).
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Positive Airway Pressure(CPAP) Group | The continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure and the the cardiovascular drugs based on the guidelines. |
| FG001 | Control | The controls only received the cardiovascular drugs based on the guidelines but without continuous positive airway pressure machine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 243 patients were screened between January 2009 and June 2012. Out of 97 (39.9%) patients diagnosed with OSA, 5 subjects declined to participate in the study, and 9 subjects were excluded because of the following: AHI <15 (n = 8 patients) and severe heart failure (n = 1 patient).
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Positive Airway Pressure(CPAP) Group | The CPAP group received fixed-level CPAP titration using an automated pressure setting device for one night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment | 4 participants withdrew before the end of study. Two subjects were lost to follow-up in the control group, and 4 patients (all of them had no SCCE) with very poor CPAP compliance were also excluded. | Posted | Mean | Standard Deviation | mm Hg | baseline and follow-up at 36 months |
|
3 years
SCCEs included new-onset acute myocardial infarction (AMI), hospitalization for heart failure, need for repeated coronary revascularization, stroke, and death associated with cardiovascular and cerebrovascular disease.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continuous Positive Airway Pressure(CPAP) Group | The CPAP group received fixed-level CPAP titration using an automated pressure setting device for 1 night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute myocardial infarction | Cardiac disorders | severe cardiovascula | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhihong Liu | State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College | +86-01088398196 | zhihongliufuwai@163.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D008659 | Metabolic Diseases |
| D003327 | Coronary Disease |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| baseline，end of study ( up to 54 months) |
| BG001 |
| Control |
The control group received the standardized antihypertensive medications but without receiving CPAP machine. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| morning systolic and diastolic BP (mmHg) | The morning BP was measured with a mercury sphygmomanometer by an experienced physician unaware of the patient's group assignment,which was the main end point. | Mean | Standard Deviation | mm Hg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change in Epworth Sleepiness Scale (ESS) | The epworth sleepiness scale（ESS） measures a person's general level of daytime sleepiness, or their average sleep propensity in daily life (ASP). It is a simple questionnaire based on retrospective reports of the likelihood of dozing off or falling asleep in a variety of different situations. The ESS is the most commonly used method for measuring a person's ASP.The ESS ranges from 0-24, higher scores indicate more severe daytime sleepiness. | Posted | Mean | Standard Deviation | score on a scale | baseline，end of study ( up to 54 months) |
|
|
|
|
| Other Pre-specified | Cardiovascular and Cerebrovascular Events | Not Posted | Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month | Participants |
| 1 |
| 42 |
| 0 |
| 42 |
| EG001 | Control | The control subjects received standardised anti-hypertension medications according to the current guildline. | 5 | 41 | 0 | 41 |
| heart failure | Cardiac disorders | severe cardiovascula | Systematic Assessment |
|
| stroke | Nervous system disorders | severe cardiovascula | Systematic Assessment |
|
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| D006331 | Heart Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |