Improving 24-hour Blood Pressure in Obstructive Sleep Apnea

NCT04021550 | Withdrawn Early Phase 1

• 1 other identifier: H18-03130
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea

Keywords

Telmisartan; Alpha-Lipoic Acid; Continuous Positive Airway Pressure; 24-hour blood pressure

Outcome Measures

Primary Outcomes (1)

• Change in 24-hour blood pressure

  Systolic, diastolic, and mean arterial blood pressure (mmHg)

  Change from baseline of 24-hour systolic, diastolic, and mean arterial blood pressure at 6 weeks

Study Arms (2)

Combined Treatment

EXPERIMENTAL

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; Drug: Telmisartan 80mg; Dietary Supplement: Alpha-Lipoic Acid 600mg

Placebo Control

PLACEBO COMPARATOR

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; Other: Microcrystalline Cellulose

Interventions

Continuous Positive Airway Pressure CPAP DEVICE

All subjects will be advised to use their continuous positive airway pressure (CPAP) in accordance to their physician's guidelines.

Combined Treatment; Placebo Control

Telmisartan 80mg DRUG

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.

Combined Treatment

Alpha-Lipoic Acid 600mg DIETARY_SUPPLEMENT

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.

Combined Treatment

Microcrystalline Cellulose OTHER

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.

Placebo Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Heart and Stroke Foundation of Canada: collaborator
• Michael Smith Foundation for Health Research: collaborator

Related Publications (5)

• 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.

  PMID: 21504246 BACKGROUND

• 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.

  PMID: 29036393 BACKGROUND

• 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.

  PMID: 18807180 BACKGROUND

• 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.

  PMID: 27542595 BACKGROUND

• Pepin JL, Tamisier R, Barone-Rochette G, Launois SH, Levy 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.

  PMID: 20522795 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure; Telmisartan; Thioctic Acid; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carboxylic Acids; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 16, 2019
• Study Start: May 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share