| CTRI Number |
CTRI/2009/091/000459 [Registered on: 06/08/2009] |
| Last Modified On: |
09/04/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Disease and Death in Patients With Acute Decompensated Heart Failure (ASTRONAUT) |
Scientific Title of Study
Modification(s)
|
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the 6 Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality When Initiated Early After Hospitalization for Acute Decompensated Heart Failure |
| Trial Acronym |
ASTRONAUT |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CSPP100A2368; version 3 Dt 3-Nov-2011 |
Protocol Number |
| NCT00894387 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Murugananthan K |
| Designation |
Head-Clinical Development |
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Murugananthan K |
| Designation |
Head-Clinical Development |
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
02224958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Murugananthan K |
| Designation |
Head-Clinical Development |
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
02224958585 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Novartis Pharma AG, Basel, Switzerland |
|
Primary Sponsor
Modification(s)
|
| Name |
Novartis Healthcare Private Limited |
| Address |
Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai – 400 018. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India
Argentina
Belgium
Brazil
Bulgaria
Canada
Colombia
Czech Republic
Finland
France
Germany
Hungary
Iraq
Israel
Italy
Philippines
Poland
Romania
Singapore
Slovakia
Spain
Sweden
Taiwan
Turkey |
Sites of Study
Modification(s)
|
| No of Sites = 19 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Maniyal Vijaykumar |
Amrita Institute of Medical Sciences |
Amrita Lane,-682026
|
09446301348
0484-2802133
care@aims.amrita.edu |
| Dr. Jaspal Singh Arneja |
Arneja Heart Institute |
123, Ramdaspeth,Behind Somalwar School,-440 010
Nagpur
MAHARASHTRA |
09823066007
0712 2450539
jaspalarneja2000@yahoo.com |
| Dr. Darshan Bankar |
Bankers Heart Institute |
Near Tagore Nagar, Opposite Suryakiran Building,O.P Road, -
Vadodara
GUJARAT |
0265 2324004
0265 2327401
info@bankersheart.com |
| Dr. Aziz Khan |
Crescent Hospital & Heart Centre |
Near Lokmat Square,Dhantoli-440 012
Nagpur
MAHARASHTRA |
09823056551
0712 2420698
khandraziz@yahoo.com |
| Dr. Nitin Patki |
Deenanath Mangeshkar Hospital and Research Centre |
Karve Road, Erandawane,Near Mahtre Bridge-411004
Pune
MAHARASHTRA |
09822041699
020 25466584
nitin1patki@gmail.com |
| Dr. Atul Mathur |
Escorts Heart Institute and Research Centre |
Okhla Road,,-110025
New Delhi
DELHI |
+91 9810187115
011 26825112
atul_mathur@hotmail.com |
| Dr. Golla Nagendra Prasad |
Frontier Lifeline Pvt Ltd |
R-30/C, Ambattur, ,Industrial Estate Road, Mugappair,-600101
Chennai
TAMIL NADU |
09790801696
+9144 26565150
prasad_golla@yahoo.com |
| Dr. Rajpal Abhaichand |
G Kuppuswamy Naidu Memorial Hospital |
P. N. Dalayam,PO Box No. 6327-641037
Coimbatore
TAMIL NADU |
09443272172
0471-446433
|
| Dr. Milind Gadkari |
KEM Hospital |
489, Sardar Moodliar Road,Rastapeth-411011
Pune
MAHARASHTRA |
09822030120
020 66202260
gadkaris@gmail.com |
| Dr. Chockalingam |
Kovai Medical Center and Hospital Limited |
Avanashi road, ,-641 014
Coimbatore
TAMIL NADU |
0422 4323124
91 0422 4214020
kclingam@gmail.com |
| Dr. Rajendra Kumar Premchand |
Krishna Institute of Medical Sciences |
1-8-31/1, Minister road,-500003
|
09848029443
4027755363
kumarpre@hotmail.com |
| Dr Ajaykumar Mahajan |
Lokmanya Tilak Municipal General Hospital |
Lokmanya Tilak Municipal General Hospital, Dept. of pharmacology, 2nd flr, College building, Sion, Mumbai- 400022
Mumbai
MAHARASHTRA |
9869032639
draum@rediffmail.com |
| Dr. Naveen Chander Reddy |
Mediciti Hospitals |
5-9-22,,Secretariat Road-500 063
Hyderabad
ANDHRA PRADESH |
91 9848045814
04023299078
prodduturnaveen@yahoo.co.in |
| Dr. Anil Bharani |
MGM Medical College & M.Y Hospital |
119,Ravindra Nagar-
Indore
MADHYA PRADESH |
09425057944
0731 2526839
anilbharani@gmail.com |
| Dr. Ravikishore A.G |
Narayana Hrudayalaya Institute of Medical Sciences |
Dept. of Cardiology, No. 258/A,Bommasandra Industrial Area, Anekal Taluk-560099
Bangalore
KARNATAKA |
09980030155
ravikishoreag@yahoo.co.in |
| Dr. Mukund Kumbla |
Omega Hospital |
Mahaveer Circle,Pupwell Circle-575002
Bangalore
KARNATAKA |
09845082811
08242430700
mukundlumble@hotmail.com |
| Dr. Jagdish Hiremath |
Poona Hospital and Research Centre |
27, Sadashiv Peth,-400030
Pune
MAHARASHTRA |
09822022441
020 24338181
jagdish_hiremath@vsnl.net |
| Dr. C. N. Manjunath |
Sri Jayadeva Institue of Cardiology |
Bannerghatta road, 9th block,Jayanagar-560069
Bangalore
KARNATAKA |
09844006699
080 22977395
cnm_vidhatri@satyam.net.in |
| Dr. S. S. Iyengar |
St. John's Medical College Hospital |
3rd Flr-Dept. of Cardiology,Sarajpur Road-560034
Bangalore
KARNATAKA |
080-22065324
080-25630603
cardioresearch@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 19 |
| Name of Committee |
Approval Status |
| Bankers Ethics Committee, Bankers Heart Institute |
Approved |
| Canara Research Ethical Committee |
Approved |
| Central India Medical Research Ethics Committee, |
Approved |
| Ethical Research Committee, Narayana Hrudayalaya Institute of Medical Sciences |
Approved |
| Ethics and Scientific Review Committee, MGM Medical College and M.Y Hospital,Indore |
Approved |
| Ethics Committee, Poona Hospital & Research Centre |
Approved |
| Global Health Concern Ethics Committee |
Approved |
| Institutional Ethics Committee, G Kuppyswamy Naidu memmorial Hospital |
Approved |
| Institutional Ethical Review Board, St. Johns Medical CollegeHospital |
Approved |
| Institutional Ethics Committee, Amrita Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Research Centre |
Approved |
| Institutional Ethics Committee, Krishna Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee,Frontier Lifeline |
Approved |
| Institutional Ethics committee,Human Research-Lokmanya Tilak Municipal Medical College |
Approved |
| KEM Hospital Ethics Committee |
Approved |
| KMCH Ethics Committee, Coimbatore |
Approved |
| Mediciti Ethics Committee |
Approved |
| Sri Jayadeva Institute Ethics Committee |
Approved |
| The Independent Ethics Committee (TIEC), Escorts Heart Institute & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute Decompensated Heart Failure
Congestive Heart Failure
, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Aliskiren |
150 milligram & 300 milligram film coated tablets |
| Comparator Agent |
Placebo |
Placebo to match aliskiren 150 milligram & 300 milligram film coated tablets taken orally in the morning throughout the entire duration of the study |
|
Inclusion Criteria
Modification(s)
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
*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.
oLVEF < 40% (measured within the last 6 months).
oHospitalization 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).
|
|
| ExclusionCriteria |
| Details |
1. 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.
2. Concomitant use of ACEI and ARB at randomization.
3. Right heart failure due to pulmonary disease.
4. Diagnosis of postpartum cardiomyopathy.
5. Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.
6. Patients with a history of heart transplant or who are on a transplant list.
7. Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Delay time of first occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months |
Time Frame: 6 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Delay time of first occurrence of either cardiovascular death or heart failure re-hospitalization through end of study |
Time Frame: 6 months |
| ? Change in the clinical summary score (assessed by KCCQ) from baseline to 1 month, 6 months and end of study |
Time Frame: 6 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="2126"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
22/05/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
18/05/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
No publication provided |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Target number of patients from India is 150.
Expected date of enrollment from India is 17th August 2009. |