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Study of Cardiovascular Disease and Obstructive Sleep Apnea | Clinical Trials | Clareo Health

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Study of Cardiovascular Disease and Obstructive Sleep Apnea

Pharmacologic Interventions for Cardiovascular Disease in Obstructive Sleep Apnea

NCT01637623•University of Wisconsin, Madison

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).

Detailed Description

The specific aims of this research project are: 1) Determine if treatment with losartan, an angiotensin type I receptor (AT1R) antagonist, or allopurinol, a XO inhibitor, normalize chemoreflex control of sympathetic outflow and ventilation and improve local vascular regulation and stiffness; and 2) Determine if these interventions reduce the severity of sleep disordered breathing and lower diurnal blood pressure.

Eligibility

Age

21 - 65 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (4)

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

Key Dates

Start Date

June 1, 2012

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

August 14, 2020

Enrollment

ACTUAL participants

Conditions

Severe Obstructive Sleep Apnea (Apnea Hypopnea Index > 30 Events/Hour)Hypertension

Interventions

Losartan

DRUG

Allopurinol

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Cardiovascular Disease and Obstructive Sleep Apnea

Inclusion Criteria

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