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Trial · NCT01897727

Etiology of Sleep Apnea-related Hyperaldosteronism - BP Treatment

NCT01897727, Not applicable, Completed, University of Alabama at Birmingham; results first posted 2014-01-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Etiology of Sleep Apnea-related Hyperaldosteronism - BP Treatment. Trials, record NCT01897727. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01897727

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Etiology of Sleep Apnea-related Hyperaldosteronism - BP Treatment
NCT number
NCT01897727
Status
Completed
Phases
Not applicable
Enrollment
41 participants, actual
Lead sponsor
University of Alabama at Birmingham
Conditions
Obstructive Sleep Apnea, Resistant Hypertension, Hyperaldosteronism
Interventions
Spironolactone, BP medication uptitration
First posted
2013-07-12
Last updated
2014-01-15
Results first posted
2014-01-15
Limitations and caveats
1. Unanticipated enrollment challenges led to small numbers of participants analyzed.~2. Open-label study design may have prevented a placebo effect.~3. An outlier in AHI was present in the control group.

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySeverity of Obstructive Sleep Apneabaseline and 3 months3 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.

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYSeverity of Obstructive Sleep Apneabaseline and 3 monthsevents/hourMEAN

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Severity of Obstructive Sleep ApneaSpironolactone-18.3Standard Deviation 16.1events/hour
Severity of Obstructive Sleep ApneaStandard of Care BP Treatment7.0Standard Deviation 30.0events/hour

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDSpironolactone8
Overall StudySTARTEDStandard of Care BP Treatment9
Overall StudyCOMPLETEDSpironolactone8
Overall StudyCOMPLETEDStandard of Care BP Treatment8
Overall StudyNOT COMPLETEDSpironolactone0
Overall StudyNOT COMPLETEDStandard of Care BP Treatment1

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalitySpironolactone
Total, all-cause mortalityStandard of Care BP Treatment
Total, other adverse eventsSpironolactone08
Total, other adverse eventsStandard of Care BP Treatment08
Total, serious adverse eventsSpironolactone08
Total, serious adverse eventsStandard of Care BP Treatment08

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
20016520BACKGROUND

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R01HL075614Etiology of Sleep Apnea-Related HyperaldosteronismCALHOUN, DAVID AUNIVERSITY OF ALABAMA AT BIRMINGHAMNATIONAL HEART, LUNG, AND BLOOD INSTITUTE2004 to 2011

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Spironolactone vs Standard of Care BP Treatment: serious adverse events

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01897727

GET https://conductscience.org/api/trials/v1/NCT01897727/registered