Trial · NCT00894387
Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
NCT00894387, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2013-10-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure. Trials, record NCT00894387. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00894387
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
- NCT number
- NCT00894387
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,639 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Acute Decompensated Heart Failure, Congestive Heart Failure
- Interventions
- Aliskiren, Placebo
- First posted
- 2009-05-07
- Last updated
- 2013-11-07
- Other registries' IDs
- eudract:2009-010236-18
- Results first posted
- 2013-10-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months | 6 months | Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months. |
| Secondary | Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months | 12 months | Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 12 months of randomization was the key secondary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 395 (394 days from randomization). The secondary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 12 months. |
| Secondary | Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months | Baseline, 1 months, 6 months and 12 months | Symptom reduction and reduction in physical limitations was assessed using the clinical summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a self-administered questionnaire and contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Health-Related Quality of Life (QoL), including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Each scale score was calculated as the mean of its item scores and transformed to a 0-100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents death. A positive change in score from baseline indicates an improvement. |
| Secondary | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | 6 months | A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation. |
| Secondary | Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months | 12 months | |
| Secondary | Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months | Baseline, 1 month, 6 months and 12 months | The reported Least square means, and Confidential Interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit, and region as factors, log baseline NT-proBNP as a continuous covariate and treatment by visit and visit by log baseline NT-proBNP as interaction terms. |
| Secondary | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | 12 months | A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months | 12 months | Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug. | Participants | NUMBER |
| SECONDARY | Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months | Baseline, 1 months, 6 months and 12 months | Full analysis set included all randomized patients who had taken at least one dose of drug. 'n' in each category indicates patients with assessable data both at baseline and corresponding time points. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | 6 months | Full analysis set included all randomized patients who had taken at least one dose of drug. | Participants | NUMBER |
| SECONDARY | Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months | 12 months | Full ananlysis set included all randomized patients who had at least one dose of study drug. | Participants | NUMBER |
| PRIMARY | Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months | 6 months | Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug. | Participants | NUMBER |
| SECONDARY | Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months | Baseline, 1 month, 6 months and 12 months | Full analysis set included all randomized patients who had taken at least one dose of study drug. 'n' in each category indicates patients with assessable date at baseline and each corresponding time point. | pg/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | 12 months | Full analysis set included all randomized patients who had taken at least one dose of study drug. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months | Aliskiren | Secondary Composite Endpoint | 283 | Participants | |
| Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months | Placebo | Secondary Composite Endpoint | 301 | Participants | |
| Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months | Aliskiren | Cardiovascular death | 126 | Participants | |
| Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months | Placebo | Cardiovascular death | 137 | Participants | |
| Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months | Aliskiren | Heart faliure re-hospitalization | 212 | Participants | |
| Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months | Placebo | Heart faliure re-hospitalization | 224 | Participants | |
| Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months | Aliskiren | 1 Month (n= 574, 571) | 24.13 | Standard Error 0.903 | units on a scale |
| Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months | Placebo | 1 Month (n= 574, 571) | 23.58 | Standard Error 0.908 | units on a scale |
| Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months | Aliskiren | 6 Months (n= 485, 474) | 26.54 | Standard Error 1.004 | units on a scale |
| Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months | Placebo | 6 Months (n= 485, 474) | 24.51 | Standard Error 1.016 | units on a scale |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aliskiren | 821 | |
| Overall Study | STARTED | Placebo | 818 | |
| Overall Study | Safety Set | Aliskiren | 808 | |
| Overall Study | Safety Set | Placebo | 810 | |
| Overall Study | Full Analysis Set | Aliskiren | 808 | |
| Overall Study | Full Analysis Set | Placebo | 807 | |
| Overall Study | Completed Primary Efficacy Phase (6 m) | Aliskiren | 717 | |
| Overall Study | Completed Primary Efficacy Phase (6 m) | Placebo | 707 | |
| Overall Study | Completed Secondary Efficacy Phase (12m) | Aliskiren | 654 | |
| Overall Study | Completed Secondary Efficacy Phase (12m) | Placebo | 640 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events830
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 | Diarrhoea | Gastrointestinal disorders | Aliskiren | 49 | 808 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 36 | 810 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Aliskiren | 155 | 808 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Placebo | 128 | 810 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Aliskiren | 42 | 808 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Placebo | 53 | 810 | |
| other | Dizziness | Nervous system disorders | Aliskiren | 35 | 808 | |
| other | Dizziness | Nervous system disorders | Placebo | 43 | 810 | |
| other | Renal impairment | Renal and urinary disorders | Aliskiren | 47 | 808 | |
| other | Renal impairment | Renal and urinary disorders | Placebo | 33 | 810 |
1 to 10 of 830Source ClinicalTrials.gov
See all 830 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aliskiren | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Aliskiren | 367 | 808 |
| Total, other adverse events | Placebo | 333 | 810 |
| Total, serious adverse events | Aliskiren | 421 | 808 |
| Total, serious adverse events | Placebo | 435 | 810 |
Source ClinicalTrials.gov
Papers5
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Aliskiren vs Placebo: Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months | Trial comparisons |
| Aliskiren vs Placebo: serious adverse events | 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/NCT00894387
GET https://conductscience.org/api/trials/v1/NCT00894387/results?page=2