Trial · NCT00094302
Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function
NCT00094302, Phase 3, Completed, Carelon Research; results first posted 2015-03-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function. Trials, record NCT00094302. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00094302
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function
- NCT number
- NCT00094302
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,445 participants, actual
- Lead sponsor
- Carelon Research
- Conditions
- Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive
- Interventions
- Spironolactone, Placebo
- First posted
- 2004-10-15
- Last updated
- 2015-03-02
- Results first posted
- 2015-03-02
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | |
| Secondary | Cardiovascular Mortality | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | |
| Secondary | Aborted Cardiac Arrest | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | First incidence of aborted cardiac arrest |
| Secondary | Hospitalization for the Management of Heart Failure | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | First incidence of a hospitalization for the management of heart failure |
| Secondary | All-cause Mortality | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | |
| Secondary | Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | |
| Secondary | Cardiovascular-related Hospitalization | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | Hospitalization for MI, stroke or the management of heart failure, whichever occurred first |
| Secondary | Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | |
| Secondary | Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | |
| Secondary | New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline. | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | First incidence of new onset diabetes mellitus among subjects without a history of diabetes mellitus at baseline. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received. | Events per 100 person-years | NUMBER |
| SECONDARY | Cardiovascular Mortality | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received. | Events per 100 person-years | NUMBER |
| SECONDARY | Aborted Cardiac Arrest | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received. | Events per 100 person-years | NUMBER |
| SECONDARY | Hospitalization for the Management of Heart Failure | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received. | Events per 100 person-years | NUMBER |
| SECONDARY | All-cause Mortality | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received. | Events per 100 person-years | NUMBER |
| SECONDARY | Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received. | Events per 100 person-years | NUMBER |
| SECONDARY | Cardiovascular-related Hospitalization | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received. | Events per 100 person-years | NUMBER |
| SECONDARY | Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received. | Events per 100 person-years | NUMBER |
| SECONDARY | Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received. | Events per 100 person-years | NUMBER |
| SECONDARY | New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline. | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | All Participants who were randomized and did not have a history of diabetes mellitus at baseline were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received. | Events per 100 person-years | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First | Placebo | 6.6 | Events per 100 person-years | ||
| Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First | Spironolactone | 5.9 | Events per 100 person-years | ||
| Cardiovascular Mortality | Placebo | 3.1 | Events per 100 person-years | ||
| Cardiovascular Mortality | Spironolactone | 2.8 | Events per 100 person-years | ||
| Aborted Cardiac Arrest | Placebo | 0.09 | Events per 100 person-years | ||
| Aborted Cardiac Arrest | Spironolactone | 0.05 | Events per 100 person-years | ||
| Hospitalization for the Management of Heart Failure | Placebo | 4.6 | Events per 100 person-years | ||
| Hospitalization for the Management of Heart Failure | Spironolactone | 3.8 | Events per 100 person-years | ||
| All-cause Mortality | Placebo | 4.6 | Events per 100 person-years | ||
| All-cause Mortality | Spironolactone | 4.2 | Events per 100 person-years |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 1,723 | |
| Overall Study | STARTED | Spironolactone | 1,722 | |
| Overall Study | COMPLETED | Placebo | 1,306 | |
| Overall Study | COMPLETED | Spironolactone | 1,316 | |
| Overall Study | NOT COMPLETED | Placebo | 417 | |
| Overall Study | NOT COMPLETED | Spironolactone | 406 |
Source ClinicalTrials.gov
Adverse events2,040
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ABDOMINAL PAIN | Cardiac disorders | Placebo | 0 | 1,723 | 0 |
| other | ABDOMINAL PAIN | Cardiac disorders | Spironolactone | 2 | 1,722 | 2 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Placebo | 28 | 1,723 | 31 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Spironolactone | 31 | 1,722 | 34 |
| other | ABDOMINAL PAIN | Hepatobiliary disorders | Placebo | 1 | 1,723 | 1 |
| other | ABDOMINAL PAIN | Hepatobiliary disorders | Spironolactone | 2 | 1,722 | 2 |
| other | ABDOMINAL PAIN | Musculoskeletal and connective tissue disorders | Placebo | 3 | 1,723 | 4 |
| other | ABDOMINAL PAIN | Musculoskeletal and connective tissue disorders | Spironolactone | 6 | 1,722 | 6 |
| other | ABNORMAL BMP | General disorders | Placebo | 5 | 1,723 | 9 |
| other | ABNORMAL BMP | General disorders | Spironolactone | 1 | 1,722 | 1 |
1 to 10 of 2,040Source ClinicalTrials.gov
See all 2,040 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Spironolactone | ||
| Total, other adverse events | Placebo | 1,086 | 1,723 |
| Total, other adverse events | Spironolactone | 1,152 | 1,722 |
| Total, serious adverse events | Placebo | 855 | 1,723 |
| Total, serious adverse events | Spironolactone | 835 | 1,722 |
Source ClinicalTrials.gov
Papers80
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Spironolactone vs Placebo: 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/NCT00094302
GET https://conductscience.org/api/trials/v1/NCT00094302/registered?page=2