Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure (ASTRONAUT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00894387
First received: May 5, 2009
Last updated: October 15, 2013
Last verified: October 2013
Results First Received: August 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Acute Decompensated Heart Failure
Congestive Heart Failure
Interventions: Drug: Aliskiren
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Of the 2134 screened patients (including

1 patient who was screened twice), 1639 patients were randomized.


Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Aliskiren     Placebo  
STARTED     821 [1]   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 [2]   643  
NOT COMPLETED     175     175  
Adverse Event                 44                 45  
Abnormal Laboratory values                 2                 2  
Unsatisfactory therapeutic effect                 0                 1  
Lost to Follow-up                 3                 5  
Administrative problems                 2                 2  
Death                 77                 76  
Protocol Deviation                 4                 0  
Patient's request                 25                 30  
Other (Missing)                 5                 3  
Mis-randomized                 13                 9  
GCP non-compliance                 0                 2  
[1] "Started" indicates all randomized patients
[2] "Completed" indicates patients whose treatment duration completed as per protocol



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Aliskiren     Placebo     Total  
Number of Participants  
[units: participants]
  808     807     1615  
Age  
[units: years]
Mean ± Standard Deviation
  64.7  ± 12.44     64.5  ± 11.88     64.6  ± 12.16  
Gender  
[units: participants]
     
Female     171     197     368  
Male     637     610     1247  



  Outcome Measures
  Show All Outcome Measures

1.  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 Frame: 6 months ]

2.  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 Frame: 12 months ]

3.  Secondary:   Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months   [ Time Frame: Baseline, 1 months, 6 months and 12 months ]

4.  Secondary:   Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months   [ Time Frame: 6 months ]

5.  Secondary:   Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months   [ Time Frame: 12 months ]

6.  Secondary:   Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months   [ Time Frame: Baseline, 1 month, 6 months and 12 months ]

7.  Secondary:   Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00894387     History of Changes
Other Study ID Numbers: CSPP100A2368, 2009-010236-18
Study First Received: May 5, 2009
Results First Received: August 2, 2013
Last Updated: October 15, 2013
Health Authority: United States: Food and Drug Administration