HypertensionNCT02059993

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

A study testing continuous positive airway pressure in people with Hypertension and Metabolic Disorder, run by Chinese Pulmonary Vascular Disease Research Group.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 to 75 years
Conditions the study is for: Hypertension, Metabolic Disorder
What is being tested?: continuous positive airway pressure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: No sites listed yet
Study dates: Jan 2009to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

About this study

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.

Read the 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.

Conditions: Hypertension, Metabolic Disorder
Being tested: continuous positive airway pressure
Keywords: continuous positive airway pressure, hypertension, coronary heart disease, metabolic disorder, obstructive sleep apnea
Medical subject headings: Hypertension, Metabolic Diseases, Coronary Disease, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

continuous positive airway pressureDevice
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

Study groups in NCT02059993
Study group	Role	What they receive
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 Receives: Device: continuous positive airway pressure
Control	No intervention	The control subjects received standardised anti-hypertension medications according to the current guildline.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment
Measured: baseline and follow-up at 36 months

Secondary outcomes (1)

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.
Measured: baseline，end of study ( up to 54 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Dec 2013

First posted11 Feb 2014 (estimated)
Study startJan 2009
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02059993
Sponsor's protocol ID: SF2009-2012
Status last verified: Jul 2020
First submitted: 9 Feb 2014
Last updated: 16 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 25125635

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Obstructive Sleep Apnea and Its Intervention on Coronary Heart Disease
ClinicalTrials.gov ID: NCT02059993
Acronym / sponsor ID: SF2009-2012
Conditions: Hypertension, Metabolic Disorder
Keywords: continuous positive airway pressure, hypertension, coronary heart disease, metabolic disorder, obstructive sleep apnea
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Chinese Pulmonary Vascular Disease Research GroupUniversity, hospital or other
Study start: Jan 2009
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 11 Feb 2014 (estimated)
Results: Posted 9 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
continuous positive airway pressure	Other	Device: continuous positive airway pressuremean 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.

Who may qualify

Ages: 45 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (10 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
continuous positive airway pressuremean 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

Primary outcome

Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment
Time frame: baseline and follow-up at 36 months

1 secondary outcome

Change in Epworth Sleepiness Scale (ESS)
Time frame: baseline，end of study ( up to 54 months)

Results and safety

Results posted to the registry on 9 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Continuous Positive Airway Pressure(CPAP) Group	42	40
Control	41	37

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

Time frame: baseline and follow-up at 36 months. Mean (Standard Deviation). Unit: mm Hg

Measure	Continuous Positive Airway Pressure(CPAP) Group n = 36	Control n = 37
Change of SBP	-8 (11)	-3 (6)
Change of DBP	-4 (11)	-3 (11)

Continuous Positive Airway Pressure(CPAP) Group vs Control: Mean Difference (Final Values): 10, p <0.05, t-test, 2 sided

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Continuous Positive Airway Pressure(CPAP) Group	1 of 42 (2.4%)	0 of 42 (0%)	Not reported
Control	5 of 41 (12.2%)	0 of 41 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25125635Huang 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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Chronic Kidney Disease, Hypertension (HTN)
Recruiting
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Enrolling by invitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zhihong Liu, MD，PhD study chair

Fuwai Hospital, National Center for Cardiovascular Diseases

Questions about this trial

What is this clinical trial studying?

A study testing continuous positive airway pressure in people with Hypertension and Metabolic Disorder, run by Chinese Pulmonary Vascular Disease Research Group.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment (time frame: baseline and follow-up at 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02059993, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.