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.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/01/005389
• Date of registration: 13-01-2015
• Prospective Registration: No
• Primary sponsor: Novartis AG
• Public title: 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.
• Scientific title: International Registry to assess mEdical Practice with lOngitudinal obseRvation for Treatment of Heart Failure (REPORT-HF) - REPORT-HF
• Date of first enrolment: 02-01-2015
• Target sample size: 20000
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10012
• Study type: Observational
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Phase 4

Countries of recruitment

Argentina, Austria, Chile, China, Colombia, Germany, Greece, India, Malaysia, Norway, Sweden, Switzerland, United Arab Emirates, United Kingdom

Contacts

• Name: Murugananthan K
• Affiliation: Novartis Healthcare Private Limited

• Name: Murugananthan K
• Affiliation: Novartis Healthcare Private Limited

Key inclusion & exclusion criteria

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: 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).



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Characterize HF patients at hospitalization and assess in-hospital and post-discharge eventsâ?? incidence (i.e., cardiac and non-cardiac primary cause of re-hospitalization, mortality)

Intervention(s)

Intervention1: NIL: NIL
Control Intervention1: NIL: NIL

Primary Outcome(s)

To identify best practice in the HF treatment, as well as extent of healthcare resources use.Timepoint: every 6 month till 3 years

Secondary Outcome(s)

to collect data on health-related quality of life as well as economic and caregiver burdenTimepoint: every 6 month till 3 years

Secondary ID(s)

REPORT-HF.2401,version number 00, date: 4-April-2014

Source(s) of Monetary Support

Novartis AG, CH-4002 Basel, Switzerland

Ethics review

Status: Approved
Approval date: 10/10/2014
Contact:

Vintage Institutional Ethics Committee, Vintage Hospital and Medical research Centre Pvt ltd, Dr.Minguel Monteiro

Status: Approved
Approval date: 27/10/2014
Contact:

Fortis Hospital Ethics Committee, Fortis Hospital, Dr Shuvanan Ray

Status: Approved
Approval date: 04/11/2014
Contact:

Rhythm Heart Institute Ethics Committee, Rhythm Heart Institute Ethics Committee, Rhythm Heart Institute,Dr Nirav Bhalani

Status: Approved
Approval date: 10/11/2014
Contact:

Institutional Scientific and Ethics Board (ISEB) Medical Research Department,KD Ambani Hospital, Dr Jamshed Dalal

Status: Approved
Approval date: 14/11/2014
Contact:

The Institutional Ethics Committee ,Yashoda Hospital, Yashoda Hospital,Dr Ravikanth

Status: Approved
Approval date: 28/11/2014
Contact:

Institutional Ethics Committee, Mysore Medical College, Dr Dinesha Basvanna

Status: Approved
Approval date: 02/12/2014
Contact:

Institutional Ethics Committee,Max Super Speciality Hospital,Dr K.K. Talwar

Status: Approved
Approval date: 04/12/2014
Contact:

Institutional Ethics Committee, Christian Medical College and Hospital, Dr Rajneesh Calton

Status: Approved
Approval date: 15/12/2014
Contact:

Institutional Ethics Committee,NH Rabindranath Tagore International Institute of Cardiac Sciences, Dr Debdatta Bhattacharya

Status: Approved
Approval date: 26/12/2014
Contact:

Institutional Ethics Committee, Fortis Escorts Hospital, Dr Arun Chopra

Status: Approved
Approval date: 29/12/2014
Contact:

KEM HOSPITAL RESEARCH CENTRE, ETHICS COMMITTEE,KEM Hospital, Dr Milind Gadkari

Status: Approved
Approval date: 31/12/2014
Contact:

Institutional Ethics Committee, Madras Medical Mission ,Dr. Ramkumar Soli Rajaram

Status: Approved
Approval date: 09/01/2015
Contact:

Independent Ethics Committee, Escorts Heart Institute,Dr Vishal Rastogi

Status: Approved
Approval date: 20/01/2015
Contact:

Institutional Ethics Committee of Sir Ganga Ram Hospital, Sir Ganga Ram Hospital, Dr Ashwani Mehta

Status: Approved
Approval date: 22/01/2015
Contact:

Ethics Committee for Research Fortis Flt. Rajan Dhall Hosptial , Fortis Flt Lt Rajan Dhall Hospital, Dr Upendra Kaul

Status: Approved
Approval date: 27/01/2015
Contact:

Institutional Ethics Committee, Care Institute of Medical Sciences, Dr.Urmil shah

Status: Approved
Approval date: 26/02/2015
Contact:

Medanta Institutional Ethics Committee,Medanta ,The Medicity, Dr V.K. Chopra

Status: Approved
Approval date: 03/03/2015
Contact:

Institutional Ethics committee, Maulana Azad Medical College & associated Lok Nayak Hospital, Dr. Sunita Aggarwal

Status: Approved
Approval date: 05/03/2015
Contact:

Narayana Hrudayalaya Medical Ethics Committee, Narayana Hrudayalaya Hospital, Dr Kannan J

Status: Approved
Approval date: 10/03/2015
Contact:

Care Hospital Care Convergence Centre, CARE Hospital, Dr Calambur Narsimhan

Status: Approved
Approval date: 24/04/2015
Contact:

Sri Jayadeva Ethics Committee, ,Dr C N Manjunath

Status: Approved
Approval date: 25/07/2015
Contact:

Institutional Ethics Committee, Rahate Surgical Hospital, Dr. Deepak Sane

Status: Approved
Approval date: 20/08/2015
Contact:

Manipal Univeristy ethics committee,Kasturba Medical College, Dr. Tom Devasia

Status: Approved
Approval date: 10/09/2015
Contact:

Drug Trial Ethics Committee, Dayanand Medical College and Hospital,Dr. Gurpreet Singh Wander

Status: Approved
Approval date: 11/09/2015
Contact:

Poona Medical Research Foundation, Institutional Ethics Committee, Dr Satyajeet N. Suryawanshi

Results

• Date Completed: 16/11/2018