A Phase 3 interventional study of Aliskiren and Placebo in Acute Decompensated Heart Failure and Congestive Heart Failure, sponsored by Novartis Pharmaceuticals. Completed at 308 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-07.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 1,639 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Novartis Pharmaceuticals is the lead sponsor of 2,711 studies on the registry; 218 are open to participants now.
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Patients with a diagnosis of acute heart failure expressed by symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied.
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
Drug: Aliskiren
Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
Drug: Placebo
Aliskiren 150 mg and Aliskiren 300 mg
Also known as: Aliskiren®,, Tekturna®,, Rasilez®,, SPP100
Placebo
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
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.
Time frame: 6 months
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
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.
Time frame: 12 months
Change From Baseline in the Clinical Summary Score to 1 Month, 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.
Time frame: Baseline, 1 months, 6 months and 12 months
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
Time frame: 6 months
Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months
Time frame: 12 months
Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 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.
Time frame: Baseline, 1 month, 6 months and 12 months
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
Time frame: 12 months
| Milestone | Aliskiren | Placebo |
|---|---|---|
| Started | 821 | 818 |
| Safety set | 808 | 810 |
| Full analysis set | 808 | 807 |
| Completed primary efficacy phase (6 m) | 717 | 707 |
| Completed secondary efficacy phase (12m) | 654 | 640 |
| Completed | 646 | 643 |
| Not completed | 175 | 175 |
| Withdrew: Adverse event | 44 | 45 |
| Withdrew: Abnormal laboratory values | 2 | 2 |
| Withdrew: Unsatisfactory therapeutic effect | 0 | 1 |
| Withdrew: Lost to follow-up | 3 | 5 |
| Withdrew: Administrative problems | 2 | 2 |
| Withdrew: Death | 77 | 76 |
| Withdrew: Protocol deviation | 4 | 0 |
| Withdrew: Patient's request | 25 | 30 |
| Withdrew: Other (missing) | 5 | 3 |
| Withdrew: Mis-randomized | 13 | 9 |
| Withdrew: Gcp non-compliance | 0 | 2 |
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.
| Participants | Aliskiren | Placebo |
|---|---|---|
| Secondary Composite Endpoint | 283 | 301 |
| Cardiovascular death | 126 | 137 |
| Heart faliure re-hospitalization | 212 | 224 |
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.
| units on a scale | Aliskiren | Placebo |
|---|---|---|
| 1 Month (n= 574, 571) | 24.13 ± 0.903 | 23.58 ± 0.908 |
| 6 Months (n= 485, 474) | 26.54 ± 1.004 | 24.51 ± 1.016 |
| 12 Months (n= 241, 230) | 24.82 ± 1.268 | 24.70 ± 1.291 |
A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
| Participants | Aliskiren | Placebo |
|---|---|---|
| Cardiovascular event | 209 | 233 |
| Cardiovascular death | 77 | 85 |
| Heart faliure re-hospitalization | 153 | 166 |
| All-cause myocardial infarction | 14 | 23 |
| Fatal myocardial infarction | 2 | 6 |
| Non-fatal myocardial infarction | 12 | 22 |
| All-cause stroke | 13 | 22 |
| Fatal stroke | 6 | 4 |
| Non-fatal stroke | 13 | 22 |
| Resuscitated sudden death | 3 | 8 |
| Participants | Aliskiren | Placebo |
|---|---|---|
| Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months | 144 | 148 |
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.
| Participants | Aliskiren | Placebo |
|---|---|---|
| Primary Composite Endpoint | 201 | 214 |
| Cardiovascular death | 77 | 85 |
| Heart faliure re-hospitalization | 153 | 166 |
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.
| pg/mL | Aliskiren | Placebo |
|---|---|---|
| Month 1 (n= 669, 675) | 0.86 (0.81 to 0.91) | 0.95 (0.90 to 1.00) |
| Month 6 (n= 569, 556) | 0.64 (0.59 to 0.70) | 0.76 (0.70 to 0.82) |
| Month 12 (n=447, 425) | 0.62 (0.56 to 0.68) | 0.74 (0.67 to 0.82) |
A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
| Participants | Aliskiren | Placebo |
|---|---|---|
| Cardiovascular event | 293 | 321 |
| Cardiovascular death | 126 | 137 |
| Heart faliure re-hospitalization | 212 | 224 |
| All-cause myocardial infarction | 18 | 38 |
| Fatal myocardial infarction | 4 | 12 |
| Non-fatal myocardial infarction | 16 | 36 |
| All-cause stroke | 18 | 27 |
| Fatal stroke | 6 | 7 |
| Non-fatal stroke | 18 | 27 |
| Resuscitated sudden death | 5 | 10 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aliskiren | — | 421/808 (52.1%) | 367/808 (45.4%) |
| Placebo | — | 435/810 (53.7%) | 333/810 (41.1%) |
| Event | Aliskiren | Placebo |
|---|---|---|
| Cardiac failureCardiac disorders | 147/808 | 155/810 |
| Cardiac failure chronicCardiac disorders | 50/808 | 62/810 |
| Cardiac failure acuteCardiac disorders | 58/808 | 60/810 |
| Cardiac failure congestiveCardiac disorders | 21/808 | 31/810 |
| PneumoniaInfections and infestations | 25/808 | 27/810 |
| DeathGeneral disorders | 21/808 | 25/810 |
| HypotensionVascular disorders | 24/808 | 16/810 |
| Renal failure acuteRenal and urinary disorders | 20/808 | 12/810 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 20/808 | 18/810 |
| Atrial fibrillationCardiac disorders | 14/808 | 16/810 |
| Event | Aliskiren | Placebo |
|---|---|---|
| HyperkalaemiaMetabolism and nutrition disorders | 155/808 | 128/810 |
| HypotensionVascular disorders | 117/808 | 83/810 |
| CoughRespiratory, thoracic and mediastinal disorders | 59/808 | 53/810 |
| HypokalaemiaMetabolism and nutrition disorders | 42/808 | 53/810 |
| DiarrhoeaGastrointestinal disorders | 49/808 | 36/810 |
| Renal impairmentRenal and urinary disorders | 47/808 | 33/810 |
| DizzinessNervous system disorders | 35/808 | 43/810 |
| Age Continuous(years) | Aliskiren | Placebo | Total |
|---|---|---|---|
| Mean | 64.7 ± 12.44 | 64.5 ± 11.88 | 64.6 ± 12.16 |
| Sex: Female, Male(Participants) | Aliskiren | Placebo | Total |
|---|---|---|---|
| Female | 171 | 197 | 368 |
| Male | 637 | 610 | 1247 |
Showing the first 100 of 308 sites across 24 countries.
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aliskiren