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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Severity of Obstructive Sleep Apnea | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Severity of Obstructive Sleep Apnea | baseline and 3 months | events/hour | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Severity of Obstructive Sleep Apnea | Spironolactone | -18.3 | Standard Deviation 16.1 | events/hour | |
| Severity of Obstructive Sleep Apnea | Standard of Care BP Treatment | 7.0 | Standard Deviation 30.0 | events/hour |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Spironolactone | 8 | |
| Overall Study | STARTED | Standard of Care BP Treatment | 9 | |
| Overall Study | COMPLETED | Spironolactone | 8 | |
| Overall Study | COMPLETED | Standard of Care BP Treatment | 8 | |
| Overall Study | NOT COMPLETED | Spironolactone | 0 | |
| Overall Study | NOT COMPLETED | Standard of Care BP Treatment | 1 |
Source ClinicalTrials.gov
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.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Spironolactone | ||
| Total, all-cause mortality | Standard of Care BP Treatment | ||
| Total, other adverse events | Spironolactone | 0 | 8 |
| Total, other adverse events | Standard of Care BP Treatment | 0 | 8 |
| Total, serious adverse events | Spironolactone | 0 | 8 |
| Total, serious adverse events | Standard of Care BP Treatment | 0 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20016520 | BACKGROUND |
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HL075614 | Etiology of Sleep Apnea-Related Hyperaldosteronism | CALHOUN, DAVID A | UNIVERSITY OF ALABAMA AT BIRMINGHAM | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2004 to 2011 |
Source NIH RePORTER
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 |
Source Trial comparisons
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.
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