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Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Resistant Hypertension

Primary Purpose

Resistant Hypertension, Obstructive Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

continuous positive airway pressure

About this trial

This is an interventional treatment trial for Resistant Hypertension focused on measuring obstructive sleep apnea, resistant hypertension, refractory hypertension, continuous positive airway pressure, blood pressure control

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 - 65
known hypertension on ≧ 3 anti-hypertensive drugs
Apnea-hypopnea index ≧15
able to give informed written consent

Exclusion Criteria:

moderate renal impairment (glomerular filtration rate <30 mL/min/m2 )
endocrine/renal/cardiac causes of secondary HT
congestive heart failure and clinically fluid overloaded
On drugs that elevates BP e.g. NSAID, steroid
Non-compliance to anti-hypertensive medications
Unstable medical conditions such as unstable angina, recent myocardial infarction/stroke within 3 months
Active inflammatory/infective conditions e.g. rheumatoid arthritis
Excessive sleepiness that can be risky e.g. occupational driver, machine operator
Modification/changes of anti-hypertensive regimen within 8 weeks

Sites / Locations

Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

continuous positive airway pressure

observation

Arm Description

Outcomes

Primary Outcome Measures

mean systolic blood pressure

Secondary Outcome Measures

mean arterial blood pressure

mean diastolic blood pressure

high sensitivity C-reactive protein

cardiac injury marker

oxidative stress marker

Full Information

NCT ID

NCT00881985

First Posted

April 14, 2009

Last Updated

September 30, 2019

Sponsor

The University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT00881985

Brief Title

Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Resistant Hypertension

Official Title

Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Drug-resistant Hypertension : A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

July 2019 (Actual)

Study Completion Date

July 2019 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

The University of Hong Kong

4. Oversight

5. Study Description

Brief Summary

The objectives of this study are to investigate the effect of continuous positive airway pressure (CPAP) treatment on blood pressure control and vascular inflammation in subjects with resistant hypertension and moderate obstructive sleep apnea (OSA).

Detailed Description

Resistant hypertension is defined as blood pressure that remains above goal in spite of concurrent use of 3 antihypertensive agents of different classes. Resistant hypertension is defined in order to identify patients who are at risk of having secondary causes of hypertension, and who may benefit from specific diagnostic and therapeutic applications. Despite the fact that OSA is listed as one of the causes of resistant HT , paucity of works has demonstrated the magnitude of problems of untreated OSA in subjects with resistant HT. There is so far two study demonstrating the beneficial effect of CPAP treatment in subjects with resistant HT, though both studies were flawed by not including the control group, no randomization and limited sample size. We aim at conducting a randomized controlled study to explore the beneficial effect of CPAP treatment in subjects with OSA and resistant hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Resistant Hypertension, Obstructive Sleep Apnea

Keywords

obstructive sleep apnea, resistant hypertension, refractory hypertension, continuous positive airway pressure, blood pressure control

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

continuous positive airway pressure

Arm Type

Active Comparator

Arm Title

observation

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

continuous positive airway pressure

Other Intervention Name(s)

CPAP

Intervention Description

Use CPAP whenever sleep

Primary Outcome Measure Information:

Title

mean systolic blood pressure

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

mean arterial blood pressure

Time Frame

8 weeks

Title

mean diastolic blood pressure

Time Frame

8 weeks

Title

high sensitivity C-reactive protein

Time Frame

8 weeks

Title

cardiac injury marker

Time Frame

8 weeks

Title

oxidative stress marker

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 - 65 known hypertension on ≧ 3 anti-hypertensive drugs Apnea-hypopnea index ≧15 able to give informed written consent Exclusion Criteria: moderate renal impairment (glomerular filtration rate <30 mL/min/m2 ) endocrine/renal/cardiac causes of secondary HT congestive heart failure and clinically fluid overloaded On drugs that elevates BP e.g. NSAID, steroid Non-compliance to anti-hypertensive medications Unstable medical conditions such as unstable angina, recent myocardial infarction/stroke within 3 months Active inflammatory/infective conditions e.g. rheumatoid arthritis Excessive sleepiness that can be risky e.g. occupational driver, machine operator Modification/changes of anti-hypertensive regimen within 8 weeks

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary SM Ip, MD

Organizational Affiliation

The University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen Mary Hospital

City

Hong Kong

ZIP/Postal Code

852

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

10770144

Citation

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Results Reference

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PubMed Identifier

9250236

Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

12515745

Citation

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Citation

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PubMed Identifier

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Citation

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Citation

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Citation

Lui MM, Tse HF, Lam DC, Lau KK, Chan CW, Ip MS. Continuous positive airway pressure improves blood pressure and serum cardiovascular biomarkers in obstructive sleep apnoea and hypertension. Eur Respir J. 2021 Nov 4;58(5):2003687. doi: 10.1183/13993003.03687-2020. Print 2021 Oct.

Results Reference

derived

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Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Resistant Hypertension

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