| CTRI Number |
CTRI/2012/12/003231 [Registered on: 17/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
05/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study for Asian Sudden Cardiac Death in Heart Failure |
|
Scientific Title of Study
|
Asian Sudden Cardiac Death in Heart Failure (ASIAN-HF) Prospective Observational Registry |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ASIAN HF (KUA90129), dated May 21, 2012 |
Protocol Number |
| NCT01633398 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shoibal Mukherjee |
| Designation |
Vice President, Medical |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
8th Floor, DLF Square M Block, Jacaranda Marg DLF City Phase II Gurgaon, Haryana India - 122002
Gurgaon
HARYANA
122002
India |
| Phone |
91-7838652395 |
| Fax |
|
| Email |
Shoibal.mukherjee@quintiles.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Suchela Srivatsa |
| Designation |
Director – Clinical Operations |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
301-A-1, Leela Business Park
MV Road, Andheri East, Mumbai 400059
Mumbai
MAHARASHTRA
400059
India |
| Phone |
91-9820712114 |
| Fax |
91-22-56774343 |
| Email |
suchela.srivatsa@quintiles.com |
|
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Source of Monetary or Material Support
|
| National University Health System, 5 Lower Kent Ridge Road, Singapore 119074 |
|
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Primary Sponsor
|
| Name |
National University Health System |
| Address |
5 Lower Kent Ridge Road, Singapore 119074 |
| Type of Sponsor |
Private hospital/clinic |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Quintiles Research India Private Limited |
B-101-106, Shapath IV, Sarkhej-Gandhinagar Road, Ahmedabad - 380051, Gujarat |
|
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Countries of Recruitment
|
China
Hong Kong
India
Japan
Malaysia
Philippines
Republic of Korea
Singapore
Thailand
Indonesia |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Calambur Narasimhan |
Care Hospitals |
6-3-248/2,
Road No.1, Banjara Hills,
Hyderabad- 500 034
Hyderabad
ANDHRA PRADESH |
914030418424
914023300795
calambur@hotmail.com |
| Dr Naik Ajay Madhukar |
CIMS Hospital Pvt. Ltd. |
Nr. Shukan Mall,
Off Science City Road, Sola,
Ahmedabad- 380060, Gujarat
Ahmadabad
GUJARAT |
0790268726
079026872620
ajay.naik@heartcareclinic.org |
| Dr Gurpreet Singh |
Dayanand Medical College & Hospital |
Unit -Hero DMC Heart Institute
Tagore Nagar, Civil Lines,
Ludhiana-141001
Ludhiana
PUNJAB |
01612304282
01612304289
drgswander@yahoo.com |
| Dr Ajay Bahl |
Department Of Cardiology, Post Graduate Institute of Medical Education and Research |
Sector 12, Chandigarh- 160012, India
Chandigarh
CHANDIGARH |
01722756513
01722744401
drajaybahl@hotmail.com |
| Dr Vijay Kumar Chopra |
Medanta- The Medicity |
Sector-38,
Gurgaon, Haryana- 122001, India
Gurgaon
HARYANA |
01126825000
01126825112
vijaykumarchopra@hotmail.com |
| Dr Mohanan Padinhare Purayil |
WestFort Hi-Tech Hospital Ltd. |
P.B. No- 930, Punkunnam,
Thrissur- 680002, Kerala
Thrissur
KERALA |
04872388899
04872388854
drmohanan@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Drug Trial Ethics Committee, Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines, Ludhiana-141001- Dr. Gurpreet Singh |
Submittted/Under Review |
| Ethics Committee of Care Institute of Medical Sciences (CIMS), Care Institute of Medical Sciences, CIMS Hospital Pvt. Ltd., Nr. Shukan Mall, Off Science City Road, Sola, Ahmedabad- 380060- Dr. Naik Ajay Madhukar |
Approved |
| Institutional Ethics Committee, Post Graduate Institute of Medical Education & Research, Sector 12, Chandigarh- 160012- Dr. Ajay Bahl |
Submittted/Under Review |
| Institutional Ethics Committee, WestFort Hi-Tech Hospital Ltd, P.B. No- 930, Punkunnam, Thrissur- 680002, Kerala |
Approved |
| Institutional Ethics Committee,Care Foundation/Care Hospital, , Road No.1, Banjara Hills, Hyderabad- 500 034- Dr. Calambur Narasimhan |
Submittted/Under Review |
| Medanta Independent Ethics Committee, Medanta- The Medicity, Sector-38, Gurgaon, Haryana- 122001- Dr. Vijay Kumar Chopra |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I508||Other heart failure, Patients with symptomatic Heart Failure and left ventricular systolic dysfunction (ejection fraction 40%), |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults (more than 18 years)
2. Symptomatic HF (Stage C HF regardless of functional status)
Patients should have a current diagnosis of symptomatic HF within 6 months of an episode of decompensated heart failure, which either:
• resulted in a hospital admission (primary diagnosis) or
• was treated in out-patient clinic
3. Left ventricular systolic dysfunction (ejection fraction less than 40% on baseline echocardiography)
4. Available for follow-up over 3 years
|
|
| ExclusionCriteria |
| Details |
1. Severe valve disease as the primary cause of HF
2. Life threatening co-morbidity with life expectancy of less than 1 year
3. Unable or unwilling to give consent
4. Concurrent participation in a clinical therapeutic trial which requires patient consent
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence (burden) of Sudden Cardiac Deaths (SCD) in Asian patients with HF followed in a representative setting of Asian cardiology centers |
Baseline Visit up to 3 years (Last Visit/Visit 5) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Risk factors for SCD among Asian patients with Heart Failure |
Baseline Visit up to 3 years (Last Visit/Visit 5) |
| Burden and risk factors of outcomes other than SCD (all-cause and cause-specific mortality and hospitalization) |
Baseline Visit up to 3 years (Last Visit/Visit 5) |
| Sociocultural barriers to device therapy among Asian patients |
Baseline Visit |
|
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Target Sample Size
|
Total Sample Size="5000"
Sample Size from India="800"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/11/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/10/2012 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective observational multinational Asian registry of patients with symptomatic Heart Failure (HF) (Stage C) and left ventricular systolic dysfunction (ejection fraction less than 40%) with the broad purpose of determining the mortality (incidence) burden of HF in Asian patients, and more specifically to define the burden and risk factors of SCD, as well as the sociocultural barriers to preventive device therapy. The specific aims of the study are to determine the burden (incidence) of Sudden Cardiac Death (SCD) in Asian patients with Heart Failure (HF) followed in a representative setting of Asian cardiology centers, to determine the risk factors for SCD among Asian patients with HF, to determine the burden and risk factors of outcomes other than SCD (all-cause and cause-specific mortality and hospitalization) and to understand the sociocultural barriers to device therapy among Asian patients.
This proposed registry is expected to advance fundamental understanding of the burden and predictors of preventable death among Asian patients with HF. The knowledge gained will be critical for guiding resource allocation and planning preventive strategies to address the unmet and growing clinical needs of patients with cardiovascular disease in Asia. |