Status:
COMPLETED
Etiology of Sleep Apnea-related Hyperaldosteronism - BP Treatment
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obstructive Sleep Apnea
Resistant Hypertension
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief Summary
Hypertension affects an estimated 60-70 million Americans, predisposing them to potentially life threatening cardiovascular complications. Resistant hypertension, defined as uncontrolled blood pressur...
Eligibility Criteria
Inclusion
- Resistant hypertension defined as office BP that is uncontrolled with 3 or more antihypertensive medications
- Moderate-severe OSA defined as AHI ≥15 events/hr
- Self-reported adherence \>80% with prescribed antihypertensive medications.
Exclusion
- Ongoing use of a potassium sparing diuretic
- History of congestive heart failure (ejection fraction of \<40%)
- Chronic kidney disease (creatinine clearance \<60 ml/min)
- History of cardiovascular disease (stroke, TIA, myocardial infarction, or revascularization procedure)
- Known or suspected history of secondary cause of hypertension other than primary aldosteronism
- Severe nocturnal hypoxemia (O2 desaturation nadir \<60%)
- White coat hypertension defined as office BP \>140/90 mm Hg and ambulatory daytime BP \<135/85 mm Hg
- Central sleep apnea (defined as 5% or more of the apneas as central apneas) and/or the presence of any Cheyne-Stokes breathing
- Subjects working shift work or having other known circadian rhythm disorders such that their sleep-wake schedule is altered
- Excessive daytime sleepiness as indicated by an Epworth score of \>10
- Pregnant Women
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01897727
Start Date
January 1 2009
Last Update
January 15 2014
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294