Study of Cardiovascular Disease and Obstructive Sleep Apnea
Condition: Severe Obstructive Sleep Apnea (Apnea Hypopnea Index > 30 Events/Hour); Hypertension
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Cardiovascular Diseases
Intervention: Losartan; Allopurinol; Placebo
Intervention description: 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.; Allopurinol 300 mg daily for 6 weeks; Placebo capsule daily for 6 weeks
Intervention MeSH terms: Allopurinol; Losartan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hypertension; High Blood Pressure; Sleep Apnea; Obstructive Sleep Apnea; OSA

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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)

        Exclusion Criteria:

          -  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