4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Improving 24-hour Blood Pressure in Obstructive Sleep Apnea

Improving 24-hour Blood Pressure in Obstructive Sleep Apnea

Study Description
Brief Summary:
This study examines the combined effects of an angiotensin receptor blocker (ARB), antioxidant supplementation, and continuous positive airway pressure (CPAP) therapy on the lowering of 24-hour blood pressure in persons with moderate to severe Obstructive Sleep Apnea (OSA). All participants will undergo CPAP therapy as prescribed by their doctor; however, half of the participants will receive the combined ARB and antioxidant treatment while the other half of the participants will receive a placebo.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Continuous Positive Airway Pressure CPAP Drug: Telmisartan 80mg Dietary Supplement: Alpha-Lipoic Acid 600mg Other: Microcrystalline Cellulose Early Phase 1

Detailed Description:

OSA is a sleep disorder characterized by repetitive collapses (apneas) or partial collapses (hypopneas) of the upper airway. These airway obstructions result in intermittent reductions in arterial oxygen saturation (hypoxia), which causes a reflexive increase in sympathetic activation and systemic vasoconstriction. Resumption of breathing results in transient surges in blood pressure (BP) that can reach as high as 240/130 mm/Hg.

OSA effects up to 24% of the adult population and evidence suggests a causal relationship between OSA and cardiovascular disease (CVD) development. While the exact mechanisms are unknown, data from animal and human models suggest that exposure to chronic intermittent hypoxia (IH) plays a significant role in the pathogenesis of cardiovascular comorbidity. Persons with OSA exhibit increased daytime sympathetic activity, markers of oxidative stress, and vasoactive hormones, particularly angiotensin II, that contribute to systemic vasoconstriction. These factors contribute to early endothelial dysfunction and contribute to sustained elevations in BP.

While CPAP is the gold standard OSA treatment, adherence rates are low and evidence suggests that treatment does not reduce the rates of CVD in large population-based studies.

Telmisartan is a receptor blocker for angiotensin II and not only has BP lowering effects, but also has unique anti-inflammatory properties and beneficial influences on endothelial function. The addition of an antioxidant supplement may increase the reactive oxygen species scavenging capacity and, in combination with ARB treatment, may provide more robust effects on BP in persons with OSA.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Combined Treatment of Angiotensin Receptor Blocker and Antioxidant Supplementation as a Novel Adjunctive Therapy for 24-hour Blood Pressure Improvement in Obstructive Sleep Apnea
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: Combined Treatment
Subjects will be given 80 mg/day Telmisartan + 600 mg/day Alpha-Lipoic Acid. Subjects will also be prescribed CPAP therapy by their physician. Subjects will be instructed to use their CPAP device according to their physician's guidelines.
 Device: Continuous Positive Airway Pressure CPAP
All subjects will be advised to use their continuous positive airway pressure (CPAP) in accordance to their physician's guidelines.

Drug: Telmisartan 80mg
Subjects in this group will receive 80mg/day of Telmisartan (an angiotensin receptor blocker). Treatments will be administered in pre-packaged blister packages. Subjects will take Telmisartan once per day for 6 weeks.

Dietary Supplement: Alpha-Lipoic Acid 600mg
Subjects in this group will receive 600mg/day of Alpha-Lipoic Acid (an antioxidant). Treatments will be administered in pre-packaged blister packages. Subjects will take Alpha-Lipoic Acid once per day for 6 weeks.
Placebo Comparator: Placebo Control
Subjects will be given placebo capsules. Subjects will also be prescribed CPAP therapy by their physician. Subjects will be instructed to use their CPAP device according to their physician's guidelines.
 Device: Continuous Positive Airway Pressure CPAP
All subjects will be advised to use their continuous positive airway pressure (CPAP) in accordance to their physician's guidelines.

Other: Microcrystalline Cellulose
Subjects in this group will receive two capsules of Microcrystalline Cellulose (placebo). Treatments will be administered in pre-packaged blister packages. Subjects will take placebo pills once per day for 6 weeks.
Outcome Measures
Primary Outcome Measures :
  1. Change in 24-hour blood pressure [ Time Frame: Change from baseline of 24-hour systolic, diastolic, and mean arterial blood pressure at 6 weeks ]
    Systolic, diastolic, and mean arterial blood pressure (mmHg)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Apnea/Hypopnea Index (AHI) greater than/equal to 15 events per hour of sleep
  • No prior use of CPAP
  • Body mass index less than 30kg/m2
  • Does not take ARBs or angiotensin converting enzyme inhibitors for blood pressure control
  • Females of childbearing potential on an effective or highly effective means of contraception

Exclusion Criteria:

  • Prescribed and/or taking the following medications: diuretics (including potassium-sparing diuretics), Digoxin, lithium salts, and/or nonsteroidal anti-inflammatory drugs
  • Over the counter supplements that affect the cardiovascular system, such as fish oils, vitamins, or other antioxidants
  • History of heart failure
  • History of myocardial infarction
  • History of coronary artery disease
  • History of stroke
  • History of diabetes mellitus
  • History of impaired renal function
  • History of chronic obstructive pulmonary disease
  • History of asthma
  • History of central sleep apnea
  • Smoked within the past year
  • Hypotensive (Systolic blood pressure (SBP) <90 mmHg and diastolic blood pressure (DBP) <60 mmHg)
  • Females who do not have a means of contraception, are pregnant, planning to become pregnant, and/or are breast-feeding
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Brooke Shafer, M.Sc. 250-807-8083 brooke.shafer@alumni.ubc.ca
Contact: Glen Foster, Ph.D. 250-807-8224 glen.foster@ubc.ca

Sponsors and Collaborators
University of British Columbia
Heart and Stroke Foundation of Canada
Michael Smith Foundation for Health Research
Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date April 27, 2021
Estimated Study Start Date  ICMJE January 2022
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019) 		Change in 24-hour blood pressure [ Time Frame: Change from baseline of 24-hour systolic, diastolic, and mean arterial blood pressure at 6 weeks ]
Systolic, diastolic, and mean arterial blood pressure (mmHg)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving 24-hour Blood Pressure in Obstructive Sleep Apnea
Official Title  ICMJE Combined Treatment of Angiotensin Receptor Blocker and Antioxidant Supplementation as a Novel Adjunctive Therapy for 24-hour Blood Pressure Improvement in Obstructive Sleep Apnea
Brief Summary This study examines the combined effects of an angiotensin receptor blocker (ARB), antioxidant supplementation, and continuous positive airway pressure (CPAP) therapy on the lowering of 24-hour blood pressure in persons with moderate to severe Obstructive Sleep Apnea (OSA). All participants will undergo CPAP therapy as prescribed by their doctor; however, half of the participants will receive the combined ARB and antioxidant treatment while the other half of the participants will receive a placebo.
Detailed Description

OSA is a sleep disorder characterized by repetitive collapses (apneas) or partial collapses (hypopneas) of the upper airway. These airway obstructions result in intermittent reductions in arterial oxygen saturation (hypoxia), which causes a reflexive increase in sympathetic activation and systemic vasoconstriction. Resumption of breathing results in transient surges in blood pressure (BP) that can reach as high as 240/130 mm/Hg.

OSA effects up to 24% of the adult population and evidence suggests a causal relationship between OSA and cardiovascular disease (CVD) development. While the exact mechanisms are unknown, data from animal and human models suggest that exposure to chronic intermittent hypoxia (IH) plays a significant role in the pathogenesis of cardiovascular comorbidity. Persons with OSA exhibit increased daytime sympathetic activity, markers of oxidative stress, and vasoactive hormones, particularly angiotensin II, that contribute to systemic vasoconstriction. These factors contribute to early endothelial dysfunction and contribute to sustained elevations in BP.

While CPAP is the gold standard OSA treatment, adherence rates are low and evidence suggests that treatment does not reduce the rates of CVD in large population-based studies.

Telmisartan is a receptor blocker for angiotensin II and not only has BP lowering effects, but also has unique anti-inflammatory properties and beneficial influences on endothelial function. The addition of an antioxidant supplement may increase the reactive oxygen species scavenging capacity and, in combination with ARB treatment, may provide more robust effects on BP in persons with OSA.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE
  • Device: Continuous Positive Airway Pressure CPAP
    All subjects will be advised to use their continuous positive airway pressure (CPAP) in accordance to their physician's guidelines.
  • Drug: Telmisartan 80mg
    Subjects in this group will receive 80mg/day of Telmisartan (an angiotensin receptor blocker). Treatments will be administered in pre-packaged blister packages. Subjects will take Telmisartan once per day for 6 weeks.
  • Dietary Supplement: Alpha-Lipoic Acid 600mg
    Subjects in this group will receive 600mg/day of Alpha-Lipoic Acid (an antioxidant). Treatments will be administered in pre-packaged blister packages. Subjects will take Alpha-Lipoic Acid once per day for 6 weeks.
  • Other: Microcrystalline Cellulose
    Subjects in this group will receive two capsules of Microcrystalline Cellulose (placebo). Treatments will be administered in pre-packaged blister packages. Subjects will take placebo pills once per day for 6 weeks.
Study Arms  ICMJE
  • Experimental: Combined Treatment
    Subjects will be given 80 mg/day Telmisartan + 600 mg/day Alpha-Lipoic Acid. Subjects will also be prescribed CPAP therapy by their physician. Subjects will be instructed to use their CPAP device according to their physician's guidelines.
    Interventions:
    • Device: Continuous Positive Airway Pressure CPAP
    • Drug: Telmisartan 80mg
    • Dietary Supplement: Alpha-Lipoic Acid 600mg
  • Placebo Comparator: Placebo Control
    Subjects will be given placebo capsules. Subjects will also be prescribed CPAP therapy by their physician. Subjects will be instructed to use their CPAP device according to their physician's guidelines.
    Interventions:
    • Device: Continuous Positive Airway Pressure CPAP
    • Other: Microcrystalline Cellulose
Publications *
  • Frampton JE. Telmisartan: a review of its use in cardiovascular disease prevention. Drugs. 2011 Apr 16;71(6):651-77. doi: 10.2165/11206710-000000000-00000. Review.
  • Khayat RN, Varadharaj S, Porter K, Sow A, Jarjoura D, Gavrilin MA, Zweier JL. Angiotensin Receptor Expression and Vascular Endothelial Dysfunction in Obstructive Sleep Apnea. Am J Hypertens. 2018 Feb 9;31(3):355-361. doi: 10.1093/ajh/hpx174.
  • Khayat R, Patt B, Hayes D Jr. Obstructive sleep apnea: the new cardiovascular disease. Part I: Obstructive sleep apnea and the pathogenesis of vascular disease. Heart Fail Rev. 2009 Sep;14(3):143-53. doi: 10.1007/s10741-008-9112-z. Epub 2008 Sep 20. Review.
  • Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg. 2016 Aug 19;45(1):43. doi: 10.1186/s40463-016-0156-0. Review.
  • Pépin JL, Tamisier R, Barone-Rochette G, Launois SH, Lévy P, Baguet JP. Comparison of continuous positive airway pressure and valsartan in hypertensive patients with sleep apnea. Am J Respir Crit Care Med. 2010 Oct 1;182(7):954-60. doi: 10.1164/rccm.200912-1803OC. Epub 2010 Jun 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2019) 		106
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Apnea/Hypopnea Index (AHI) greater than/equal to 15 events per hour of sleep
  • No prior use of CPAP
  • Body mass index less than 30kg/m2
  • Does not take ARBs or angiotensin converting enzyme inhibitors for blood pressure control
  • Females of childbearing potential on an effective or highly effective means of contraception

Exclusion Criteria:

  • Prescribed and/or taking the following medications: diuretics (including potassium-sparing diuretics), Digoxin, lithium salts, and/or nonsteroidal anti-inflammatory drugs
  • Over the counter supplements that affect the cardiovascular system, such as fish oils, vitamins, or other antioxidants
  • History of heart failure
  • History of myocardial infarction
  • History of coronary artery disease
  • History of stroke
  • History of diabetes mellitus
  • History of impaired renal function
  • History of chronic obstructive pulmonary disease
  • History of asthma
  • History of central sleep apnea
  • Smoked within the past year
  • Hypotensive (Systolic blood pressure (SBP) <90 mmHg and diastolic blood pressure (DBP) <60 mmHg)
  • Females who do not have a means of contraception, are pregnant, planning to become pregnant, and/or are breast-feeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brooke Shafer, M.Sc. 250-807-8083 brooke.shafer@alumni.ubc.ca
Contact: Glen Foster, Ph.D. 250-807-8224 glen.foster@ubc.ca
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04021550
Other Study ID Numbers  ICMJE H18-03130
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Glen Foster, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE
  • Heart and Stroke Foundation of Canada
  • Michael Smith Foundation for Health Research
Investigators  ICMJE Not Provided
PRS Account University of British Columbia
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯