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1 Clinical Trial Details (PDF Generation Date :- Mon, 11 Mar :36:26 GMT) CTRI Number Last Modified On 21/01/2019 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/01/ [Registered on: 13/01/2015] - Trial Registered Prospectively No Observational Follow Up Study Other An Observational, multinational Heart Failure disease registry study to identify routine patterns of diagnosis & medical care for patients of acute heart failure as well as treatment type,long term heart failure related clinical events and re-admission rates during the followup period of 3 years. International Registry to assess medical Practice with longitudinal observation for Treatment of Heart Failure (REPORT-HF) Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) REPORT-HF.2401,version number 00, date: 4-April-2014 Designation Affiliation Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Murugananthan K Head-Clinical Development Phone Fax Designation Affiliation Novartis Healthcare Private Limited Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli Mumbai Mumbai Mumbai murugananthan.k@novartis.com Details Contact Person (Public Query) Murugananthan K Head-Clinical Development Novartis Healthcare Private Limited Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli Mumbai Mumbai page 1 / 8

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Novartis AG, CH-4002 Basel, Switzerland Type of Sponsor NIL List of Countries Argentina Austria Chile China Colombia Germany Greece Malaysia Norway Sweden Switzerland United Arab Emirates United Kingdom of Principal Investigator Dr Calambur Narsimhan Dr Rajneesh Calton Dr Urmil Shah Source of Monetary or Material Support Novartis AG Primary Sponsor Details CH-4002 Basel, Switzerland Pharmaceutical industry-global NIL of Site Site Phone/Fax/ CARE Christian Medical College and cardilogy, Road # 1, Banjara Hills, , Hyderabad Hyderabad ANDHRA PRADESH cardiology, Brown Road, Ludhiana, Punjab Ludhiana PUNJAB CIMS Pvt. Ltd. Cardiology, Off.Science City Road, Sola, Ahmedabad , Gujarat, Ahmadabad GUJARAT calambur@hotmail.com caltonrajneesh@yahoo. in urmil.shah@cims.me DrAshwani Mehta Dharam Vira Heart page 2 / 8

3 Center, Sir Ganga Ram Cardiology, Sir Ganga Ram Marg, Rajinder nagar, Dr Vishal Rastogi Escorts Heart Institute cardiology, Room # 23 A, 2nd Floor, Residential Tower, Okhla Road, Dr Arun Chopra Fortis Escorts cardiology, Majitha Verka Byepass Road, Amritsar Amritsar PUNJAB Dr Upendra Kaul Fortis Flt Lt Rajan Dhall cardiology, Sector B, Pocket 1, Aruna Asif Ali Marg, Vasant Kunj,, DrShuvanan Ray Fortis cardiology, 730 Anandapur Kolkata WEST BENGAL Dr Gurpreet Singh Wander Hero DMC Heart Institute, Dayanand Medical College &, Tagore Nagar, Ludhiana (141001), Punjab Ludhiana PUNJAB DrMilind Gadkari K.E.M Cardiology, 5th Floor, Diamond Jubilee Building, KEM hospital research centre, 489 Rasta Peth. Sardar Moodliar Road, Pune Dr Tom Devasia Dr Jamshed Dalal Dr Ramkumar Soli Rajaram Kasturba Medical College KD Ambani, Mumbai Madras Medical Mission SH 65, Madhav Nagar, Manipal, Karnataka Mysore KARNATAKA Cardiology, Four Bunglows, Andheri West, Mumbai Mumbai (Suburban) cardiology, 4-A,Dr.J.J.Nagar, Mogappair, drashwanimehta@gmai l.com drvrastogi@yahoo.com akchopra1@rediffmail.c om kaul.upendra@gmail.co m enquiry@fortissurgicalh ospital.com drgswander@yahoo.co m gadkaris@gmail.com tomdevasia@hotmail.co m jamshed.dalal@reliance ada.com srramkumardr@yahoo. com page 3 / 8

4 Dr Sunita Aggarwal Dr KK Talwar Maulana Azad Medical College & associated Lok Nayak Max Super Speciality Chennai Chennai TAMIL NADU cardiology, Bahadur Shah Zafar Marg, New Delhi cardiology, 2, Press Enclave Road, Saket, Dr VK Chopra Medanta,The Medicity cardiology, Sector 38, , Gurgaon Gurgaon HARYANA DrDinesha Basavanna DrKannan J Dr Debdatta Bhattacharya Dr Deepak Sane Mysore Medical College & Research Institute Narayana Hrudayalaya NH Rabindranath Tagore International Institute of Cardiac Sciences Rahate Surgical cardiology, K.R., Irwin Road Mysore KARNATAKA Cardiology, 258/A, Bommasandra Industrial Area, Anekal Taluk, Bangalore KARNATAKA cardiology, 124, Mukundapur, EM Byepass, Kolkata Kolkata WEST BENGAL 517, Kolbaswami Square, Juni Mangalwari, Nagpur, Maharashtra Nagpur DrNirav Bhalani Rhythm Heart Institute Cardiology, Lakulesh Park Society, Near Sadhuvaswani School, Airport Circle, New VIP Raod, Vadodara GUJARAT Dr Satyajeet N Suryawanshi Ruby Hall Clinic 40, Sassoon Road, Pune Pune drsunita.mamc@gmail. com k.talwar@maxhealthcar e.com vk.chopra@medanta.or g dr.dinesha@gmail.com drkannanu@yahoo.co.i n dev_heartline@rediffma il.com janenitin@gmail.com drniravbhalani@hotmail.com satyajeetsuryawanshi@ gmail.com Dr C N Manjunath Sri Jayadeva Institute of Jayanagar 9th Block, page 4 / 8

5 Details of Ethics Committee DrMinguel Rufino Monterio Cardiovascular Sciences &Research Vintage & Medical Research Centre Pvt.Ltd Bannerghatta main road, Bengaluru Bangalore KARNATAKA Medicine, Caculo Enclave, St.Inez, Panji North Goa GOA Dr A Ravi Kanth Yashoda cardiology, Raj Bhavan Road, Somajiguda Hyderabad ANDHRA PRADESH cardioresearch@jayade vacardiology.com cromgoa@gmail.com athuluri113@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Care Care Convergence Centre, CARE, Dr Calambur Narsimhan Drug Trial Ethics Committee, Dayanand Medical College and,dr. Gurpreet Singh Wander Ethics Committee for Research Fortis Flt. Rajan Dhall Hosptial, Fortis Flt Lt Rajan Dhall, Dr Upendra Kaul Fortis Ethics Committee, Fortis, Dr Shuvanan Ray Approved 10/03/2015 No Approved 10/09/2015 No Approved 22/01/2015 No Approved 27/10/2014 No Independent Ethics Committee, Escorts Heart Institute,Dr Vishal Rastogi Approved 09/01/2015 Yes Institutional Scientific and Ethics Board (ISEB) Medical Research Department,KD Ambani, Dr Jamshed Dalal Approved 10/11/2014 No Committee of Sir Ganga Ram, Sir Ganga Ram, Dr Ashwani Mehta Committee, Care Institute of Medical Sciences, Dr.Urmil shah Approved 20/01/2015 No Approved 27/01/2015 No page 5 / 8

6 Committee, Christian Medical College and, Dr Rajneesh Calton Committee, Fortis Escorts, Dr Arun Chopra Committee, Madras Medical Mission,Dr. Ramkumar Soli Rajaram Approved 04/12/2014 No Approved 26/12/2014 No Approved 31/12/2014 No committee, Maulana Azad Medical College & associated Lok Nayak, Dr. Sunita Aggarwal Approved 03/03/2015 No Committee, Mysore Medical College, Dr Dinesha Basvanna Committee, Rahate Surgical, Dr. Deepak Sane Committee,Max Super Speciality,Dr K.K. Talwar Committee,NH Rabindranath Tagore International Institute of Cardiac Sciences, Dr Debdatta Bhattacharya KEM HOSPITAL RESEARCH CENTRE, ETHICS COMMITTEE,KEM, Dr Milind Gadkari Manipal Univeristy ethics committee,kasturba Medical College, Dr. Tom Devasia Medanta Institutional Ethics Committee,Medanta,The Medicity, Dr V.K. Chopra Narayana Hrudayalaya Medical Ethics Committee, Narayana Hrudayalaya, Approved 28/11/2014 No Approved 25/07/2015 No Approved 02/12/2014 No Approved 15/12/2014 No Approved 29/12/2014 No Approved 20/08/2015 No Approved 26/02/2015 No Approved 05/03/2015 No page 6 / 8

7 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Dr Kannan J Poona Medical Research Foundation, Committee, Dr Satyajeet N. Suryawanshi Rhythm Heart Institute Ethics Committee, Rhythm Heart Institute Ethics Committee, Rhythm Heart Institute,Dr Nirav Bhalani Sri Jayadeva Ethics Committee,,Dr C N Manjunath The Committee,Yashoda, Yashoda,Dr Ravikanth Vintage Institutional Ethics Committee, Vintage and Medical research Centre Pvt ltd, Dr.Minguel Monteiro Status Not Applicable Health Type Patients Approved 11/09/2015 No Approved 04/11/2014 No Approved 24/04/2015 No Approved 14/11/2014 No Approved 10/10/2014 No Date No Date Specified Condition Characterize HF patients at hospitalization and assess in-hospital and post-discharge events incidence (i.e., cardiac and non-cardiac primary cause of re-hospitalization, mortality) Type Details Intervention NIL NIL Comparator Agent NIL NIL Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1)Patients 18 year old, or older for those countries where the adult age is above 18 year of age, hospitalized at the registry sites with primary diagnosis of acute heart failure. Diagnoses will be made by the treating physicians according to local practices and their clinical judgment (i.e., History/examination; Chest X-ray; ECG, Echocardiogram, BNP or NT-proBNP). Exclusion Criteria Details Exclusion Criteria Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Patients 18 year old, or older for those countries where the adult page 7 / 8

8 Powered by TCPDF ( age is above 18 year of age, hospitalized at the registry sites with primary diagnosis of acute heart failure. Diagnoses will be made by the treating physicians according to local practices and their clinical judgment (i.e., History/examination; Chest X-ray; ECG, Echocardiogram, BNP or NT-proBNP). Method of Generating Random Sequence Method of Concealment Blinding/Masking Not Applicable Not Applicable Not Applicable Primary Outcome Outcome Timepoints To identify best practice in the HF treatment, as well as extent of healthcare resources use. every 6 month till 3 years Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary to collect data on health-related quality of life as well as economic and caregiver burden Total Sample Size=20000 Sample Size from = /01/ /07/2014 Years=6 Months=0 Days=0 Completed Completed No publication provided every 6 month till 3 years REPORT-HF is a global prospective non-interventional disease registry. It will span 45 countries across all continents and involve 300 sites to capture data on 20,000 heart failure patients. The aim is to characterize heart failure patients at hospitalization and their disease progression post discharge. We are also interested in better understanding heart failure resource utilization, for example procedures, doctor visits, rehospitalizations, and their impact on patient outcomes. Finally we would like to also learn more about the burden of disease and the quality of life for both patients and caregivers page 8 / 8