Study of Cardiovascular Disease and Obstructive Sleep Apnea
CVD/OSA
Pharmacologic Interventions for Cardiovascular Disease in Obstructive Sleep Apnea
4 other identifiers
interventional
87
1 country
4
Brief Summary
The purpose of this study is to determine if two medicines (allopurinol and losartan) can influence heart and blood vessel health compared to placebo in patients with sleep apnea who are using continuous positive airway pressure (CPAP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2012
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 29, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
August 14, 2020
CompletedAugust 14, 2020
August 1, 2020
3 years
June 29, 2012
August 6, 2018
August 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Muscle Sympathetic Nerve Activity Responses During Hypoxia
The primary outcome variable is the change in the individual slope of the MSNA - SaO2 response curve at 6 weeks and baseline between treatment groups.
baseline and 6 weeks
Secondary Outcomes (10)
Change in Aortic Pulse Wave Velocity
baseline and 6 weeks
Cerebrovascular Conductance
baseline and 6 weeks
Forearm Vascular Conductance
baseline and 6 weeks
Change in Minute Ventilation at Normoxia
baseline and 6 weeks
Change in Minute Ventilation During Hypoxia
baseline and 6 weeks
- +5 more secondary outcomes
Study Arms (3)
Losartan
ACTIVE COMPARATORLosartan 50 mg daily for two weeks, then increased to 100mg daily for 4 weeks if asymptomatic and blood pressure within range.
Allopurinol
ACTIVE COMPARATORAllopurinol 300 mg daily for 6 weeks
Placebo
PLACEBO COMPARATORPlacebo capsule daily for 6 weeks
Interventions
Losartan 50 mg daily for two weeks, then increased to 100mg daily for 4 weeks if asymptomatic. Remain at 50 mg daily for 4 more weeks or removed from study if symptomatic.
Eligibility Criteria
You may qualify if:
- Males and females between ages of 21 and 65 years
- Apnea hypopnea index or respiratory disturbance index greater than or equal to 25 events per hour
- Subjects eligible for CPAP or BiPAP therapy
You may not qualify if:
- If subject not using CPAP, having AHI \> 60 events/hour or oxygen saturation ≤ 65% during sleep
- Presence of clinical CV disease (coronary artery disease, angina, arrhythmias (subjects with sinus arrhythmias will be reviewed by PI for enrollment), stroke, TIA, cor pulmonale, etc.), heart failure, bruits, or diabetes mellitus by clinical diagnosis/history
- Presence of pulmonary disease that results in significant hypoxemia (resting SaO2 \< 88%)
- Hypertriglyceridemia (triglycerides \>300 mg/dL), diabetes or impaired glucose tolerance (fasting plasma glucose \> 125 mg/dL)
- Patients taking angiotensin converting enzyme inhibitors, angiotensin receptor antagonists, potassium-sparing diuretics (without accompanying loop/thiazide diuretic), allopurinol, oxypurinol, febuxostat, amoxicillin, ampicillin, azathioprine or mercaptopurine.
- Patients with chronic kidney disease (Serum creatinine \>1.5 mg/dL) or history of significant hyperkalemia (Serum potassium \> 5.2 mEq/L) with ARB therapy
- Patients with history of angioedema
- Patients with bilateral,modified radical or radical mastectomies
- Patients who have a Serum potassium \> 5.0 mEq/L at the screening visit
- Female patients who are pregnant (determined by urine pregnancy test) or breastfeeding
- Patients with active MRSA or VRE (vancomycin resistant enterococcus) infection
- History of adverse reaction to allopurinol,losartan, or zolpidem\*\*
- Patients who cannot swallow oral capsules
- Patients who are hospitalized or who have been recently hospitalized (last 2 weeks)
- Inability to comply with or complete the protocol or other reasons at the discretion of the investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Aurora Bay Care
Green Bay, Wisconsin, 54308, United States
Gundersen Lutheran
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Madison
Madison, Wisconsin, 53705, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Related Publications (1)
Morgan BJ, Teodorescu M, Pegelow DF, Jackson ER, Schneider DL, Plante DT, Gapinski JP, Hetzel SJ, Dopp JM. Effects of losartan and allopurinol on cardiorespiratory regulation in obstructive sleep apnoea. Exp Physiol. 2018 Jul;103(7):941-955. doi: 10.1113/EP087006. Epub 2018 Jun 8.
PMID: 29750475RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John M. Dopp
- Organization
- University of Wisconsin School of Pharmacy
Study Officials
- PRINCIPAL INVESTIGATOR
John Dopp, Pharm.D.
UW Madison School of Pharmacy
- PRINCIPAL INVESTIGATOR
Barbara J Morgan, PhD, PT
UW Madison School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2012
First Posted
July 11, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
August 14, 2020
Results First Posted
August 14, 2020
Record last verified: 2020-08