Study of Cardiovascular Disease and Obstructive Sleep Apnea

Completed · Phase 2 · Has a placebo group

Conditions studied: Severe Obstructive Sleep Apnea (Apnea Hypopnea Index > 30 Events/Hour), Hypertension

In brief

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).

Key facts

Study ID

NCT01637623

Run by

University of Wisconsin, Madison

People needed

87

Starts

2012-06-01

Expected to finish

2015-06-01

Last updated by the study team

2020-08-14

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• Hypertension by clinical history/diagnosis (may be controlled with non- exclusionary medications) or average blood pressure > 140/90 mm Hg (using last two measurements in prior 12 months - or 1 prior blood pressure and 1 blood pressure at screening)

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

Where it is running

• Aurora Bay Care — Green Bay, Wisconsin, United States
• Gundersen Lutheran — La Crosse, Wisconsin, United States
• University of Wisconsin Madison — Madison, Wisconsin, United States
• Marshfield Clinic — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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