Trial Outcomes & Findings for Etiology of Sleep Apnea-related Hyperaldosteronism - BP Treatment (NCT NCT01897727)

Last Updated: 2014-01-15

Results Overview

3 month change in apnea-hypopnea index assessed by diagnostic, full-night polysomnography. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \> 30/h = severe.

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

baseline and 3 months

Results posted on

2014-01-15

Participant Flow

Consecutive adult patients with symptoms of OSA and resistant HTN between 2009 to 2012, were enrolled from the Hypertension Clinic at the University of Alabama at Birmingham.

There was no wash out; ongoing use of a potassium sparing diuretic, including spironolactone, eplerenone, triamterene, or amiloride precluded study participation. A total of 17 participants (out of the 41 who were enrolled) were randomized into the two groups. 24 participants met exclusion criteria before randomization.

Participant milestones

Participant milestones
Measure	Spironolactone Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP \> 140/90 mm Hg throughout the 3 month study.	Standard of Care BP Treatment Antihypertensive medication added and/or uptitrated to keep BP \< 140/90 mm Hg throughout the study.
Overall Study STARTED	8	9
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Spironolactone Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP \> 140/90 mm Hg throughout the 3 month study.	Standard of Care BP Treatment Antihypertensive medication added and/or uptitrated to keep BP \< 140/90 mm Hg throughout the study.
Overall Study Exclusion: central sleep apnea	0	1

Baseline Characteristics

Etiology of Sleep Apnea-related Hyperaldosteronism - BP Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spironolactone n=8 Participants Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP \> 140/90 mm Hg throughout the 3 month study.	Standard of Care BP Treatment n=8 Participants Antihypertensive medication added and/or uptitrated to keep BP \< 140/90 mm Hg throughout the study.	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 8.3 • n=5 Participants	56.8 years STANDARD_DEVIATION 6.3 • n=7 Participants	58.4 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 3 months

3 month change in apnea-hypopnea index assessed by diagnostic, full-night polysomnography. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \> 30/h = severe.

Outcome measures

Outcome measures
Measure	Spironolactone n=8 Participants Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP \> 140/90 mm Hg throughout the 3 month study.	Standard of Care BP Treatment n=8 Participants Antihypertensive medication added and/or uptitrated to keep BP \< 140/90 mm Hg throughout the study.
Severity of Obstructive Sleep Apnea	-18.3 events/hour Standard Deviation 16.1	7.0 events/hour Standard Deviation 30.0

Adverse Events

Spironolactone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care BP Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eric Judd

University of Alabama at Birmingham

Phone: 205 934-9281

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place