Acute Decompensated Heart Failure, Congestive Heart Failure
Conditions
Keywords
elevated BNP, reduced LVEF, Acute Heart Failure, Cardiovascular death, CHF, hospitalization, morbi-mortality trial, outcome study, endpoint driven, plasma renin activity, renin angiotensin, aldosterone system, direct renin inhibitors, BNP, KCCQ, eGFR
Brief summary
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.
Interventions
DRUGAliskiren
Aliskiren 150 mg and Aliskiren 300 mg
DRUGPlacebo
Placebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient hospitalized with a primary diagnosis of worsening heart failure ≥ 18 years of age, male or female. * 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. * LVEF \< 40% (measured within the last 6 months). * Hospitalization for ADHF and remain stabilized for at least 6 hours (defined as SBP ≥ 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization. * Elevated BNP at Visit 1 or at randomization (BNP ≥ 400 pg/ml). * Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV).
Exclusion criteria
* Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization. * Concomitant use of ACEI and ARB at randomization. * Right heart failure due to pulmonary disease. * Diagnosis of postpartum cardiomyopathy. * Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months. * Patients with a history of heart transplant or who are on a transplant list. * Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months | 12 months | — |
Countries
Argentina, Belgium, Brazil, Canada, Colombia, Czechia, Finland, France, Germany, Hungary, India, Israel, Italy, Philippines, Poland, Romania, Russia, Singapore, Slovakia, Spain, Sweden, Taiwan, Turkey (Türkiye), United States
Participant flow
Pre-assignment details
Of the 2134 screened patients (including 1 patient who was screened twice), 1639 patients were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Aliskiren 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. | 808 |
| Placebo 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. | 807 |
| Total | 1,615 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Abnormal Laboratory values | 2 | 2 |
| Overall Study | Administrative problems | 2 | 2 |
| Overall Study | Adverse Event | 44 | 45 |
| Overall Study | Death | 77 | 76 |
| Overall Study | GCP non-compliance | 0 | 2 |
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Mis-randomized | 13 | 9 |
| Overall Study | Other (Missing) | 5 | 3 |
| Overall Study | Patient's request | 25 | 30 |
| Overall Study | Protocol Deviation | 4 | 0 |
| Overall Study | Unsatisfactory therapeutic effect | 0 | 1 |
Baseline characteristics
| Characteristic | Aliskiren | Placebo | Total |
|---|---|---|---|
| Age Continuous | 64.7 years STANDARD_DEVIATION 12.44 | 64.5 years STANDARD_DEVIATION 11.88 | 64.6 years STANDARD_DEVIATION 12.16 |
| Sex: Female, Male Female | 171 Participants | 197 Participants | 368 Participants |
| Sex: Female, Male Male | 637 Participants | 610 Participants | 1247 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 367 / 808 | 333 / 810 |
| serious Total, serious adverse events | 421 / 808 | 435 / 810 |
Outcome results
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
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
Population: Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aliskiren | 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 | Primary Composite Endpoint | 201 Participants |
| Aliskiren | 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 | Cardiovascular death | 77 Participants |
| Aliskiren | 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 | Heart faliure re-hospitalization | 153 Participants |
| 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 | Primary Composite Endpoint | 214 Participants |
| 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 | Cardiovascular death | 85 Participants |
| 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 | Heart faliure re-hospitalization | 166 Participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Aliskiren | Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months | Month 1 (n= 669, 675) | 0.86 pg/mL |
| Aliskiren | Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months | Month 6 (n= 569, 556) | 0.64 pg/mL |
| Aliskiren | Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months | Month 12 (n=447, 425) | 0.62 pg/mL |
| Placebo | Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months | Month 1 (n= 669, 675) | 0.95 pg/mL |
| Placebo | Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months | Month 6 (n= 569, 556) | 0.76 pg/mL |
| Placebo | Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months | Month 12 (n=447, 425) | 0.74 pg/mL |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Aliskiren | Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months | 1 Month (n= 574, 571) | 24.13 units on a scale | Standard Error 0.903 |
| Aliskiren | Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months | 6 Months (n= 485, 474) | 26.54 units on a scale | Standard Error 1.004 |
| Aliskiren | Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months | 12 Months (n= 241, 230) | 24.82 units on a scale | Standard Error 1.268 |
| Placebo | Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months | 1 Month (n= 574, 571) | 23.58 units on a scale | Standard Error 0.908 |
| Placebo | Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months | 6 Months (n= 485, 474) | 24.51 units on a scale | Standard Error 1.016 |
| Placebo | Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months | 12 Months (n= 241, 230) | 24.70 units on a scale | Standard Error 1.291 |
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
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
Population: Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aliskiren | 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 | Secondary Composite Endpoint | 283 Participants |
| Aliskiren | 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 | Cardiovascular death | 126 Participants |
| Aliskiren | 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 | Heart faliure re-hospitalization | 212 Participants |
| Placebo | 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 | Secondary Composite Endpoint | 301 Participants |
| Placebo | 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 | Cardiovascular death | 137 Participants |
| Placebo | 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 | Heart faliure re-hospitalization | 224 Participants |
Secondary
Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months
Time frame: 12 months
Population: Full ananlysis set included all randomized patients who had at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aliskiren | Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months | 144 Participants |
| Placebo | Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months | 148 Participants |
Secondary
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
Population: Full analysis set included all randomized patients who had taken at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Heart faliure re-hospitalization | 212 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Non-fatal myocardial infarction | 16 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Cardiovascular death | 126 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | All-cause stroke | 18 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Fatal stroke | 6 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | All-cause myocardial infarction | 18 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Non-fatal stroke | 18 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Cardiovascular event | 293 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Resuscitated sudden death | 5 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Fatal myocardial infarction | 4 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Resuscitated sudden death | 10 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Cardiovascular event | 321 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Cardiovascular death | 137 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Heart faliure re-hospitalization | 224 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | All-cause myocardial infarction | 38 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Fatal myocardial infarction | 12 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Non-fatal myocardial infarction | 36 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Fatal stroke | 7 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | Non-fatal stroke | 27 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months | All-cause stroke | 27 Participants |
Secondary
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
Population: Full analysis set included all randomized patients who had taken at least one dose of drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Cardiovascular event | 209 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Cardiovascular death | 77 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Heart faliure re-hospitalization | 153 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | All-cause myocardial infarction | 14 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Fatal myocardial infarction | 2 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Non-fatal myocardial infarction | 12 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | All-cause stroke | 13 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Fatal stroke | 6 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Non-fatal stroke | 13 Participants |
| Aliskiren | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Resuscitated sudden death | 3 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Fatal stroke | 4 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Cardiovascular event | 233 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Non-fatal myocardial infarction | 22 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Cardiovascular death | 85 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Resuscitated sudden death | 8 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Heart faliure re-hospitalization | 166 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | All-cause stroke | 22 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | All-cause myocardial infarction | 23 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Non-fatal stroke | 22 Participants |
| Placebo | Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months | Fatal myocardial infarction | 6 Participants |