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CTRI Number  CTRI/2022/12/048457 [Registered on: 26/12/2022] Trial Registered Prospectively
Last Modified On: 06/04/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence of iron deficiency in patients with heart failure in India 
Scientific Title of Study   Prevalence of iron deficiency in patients with heart failure in India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
EPL/ID/HF/2022/01 Version 1 Dated: 08-11-22  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Onkar Swami 
Designation  Director-Medical Services 
Affiliation  Emcure Pharmaceuticals Ltd 
Address  Emcure Pharmaceuticals Limited, Survey no 255/2, Phase 1, Rajiv Gandhi ITBT Park, MIDC, Hinjawadi, Pune

Pune
MAHARASHTRA
411057
India 
Phone  020-40210098  
Fax    
Email  Onkar.Swami@emcure.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanket Newale 
Designation  Deputy General-Manager Medical Services 
Affiliation  Emcure Pharmaceuticals Ltd 
Address  Emcure Pharmaceuticals Limited, Survey no 255/2, Phase 1, Rajiv Gandhi ITBT Park, MIDC, Hinjawadi, Pune

Pune
MAHARASHTRA
411057
India 
Phone  020-40210038  
Fax    
Email  Sanket.Newale@emcure.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Nanette Suares 
Designation  Deputy Manager-Medical services 
Affiliation  Emcure Pharmaceuticals Ltd 
Address  Emcure Pharmaceuticals Limited, Survey no 255/2, Phase 1, Rajiv Gandhi ITBT Park, MIDC, Hinjawadi, Pune

Pune
MAHARASHTRA
411057
India 
Phone  020-40210186  
Fax    
Email  Nanette.Suares@emcure.co.in  
 
Source of Monetary or Material Support  
Emcure Pharmaceuticals Limited, Survey no 255/2, Phase 1, Rajiv Gandhi ITBT Park, MIDC, Hinjawadi, Pune MAHARASHTRA 411057 India  
 
Primary Sponsor  
Name  Emcure Pharmaceuticals Limited 
Address  255/2, Rajiv Gandhi IT Park, MIDC, Hinjawadi, Pune -411 057, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Onkar Swami  Emcure Pharmaceuticals Limited  Department of Medical Services, Ground floor, Head Office Building, Phase 1, Hinjawadi, Pune
Pune
MAHARASHTRA 		 020-40210098

Onkar.Swami@emcure.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dhanashree Hospital Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I509||Heart failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Patients with known cases of heart failure who are currently asymptomatic or mildly symptomatic and presented for consultation in heart failure camp.2)Treating physician is willing to share anonymized data of such patients. 
 
ExclusionCriteria 
Details  1)Treating physician is not willing to share anonymized data of such patients. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the frequency of absolute and functional iron deficiency in patients with
known cases of heart failure in India. 		 At time of enrollment 
 
Secondary Outcome  
Outcome  TimePoints 
To understand the gender difference in frequency of absolute and functional iron
deficiency in patients. 		 At time of enrollment 
To understand the age difference in frequency of absolute and functional iron
deficiency in patients. 		 At time of enrollment 
 
Target Sample Size   Total Sample Size="3600"
Sample Size from India="3600" 
Final Enrollment numbers achieved (Total)= "3365"
Final Enrollment numbers achieved (India)="3365" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/12/2022 
Date of Study Completion (India) 31/01/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
This is a multi-center, retrospective, observational, data collection study across various centers in India. Data of patients matching the inclusion and exclusion criteria will be collected by the physicians and filled in the Investigation Requisition Form (IRF) without revealing the patient’s identity. Data of these patients will be electronically stored and used for research. Demographic data and laboratory investigations will be recorded. Blood samples will be obtained for hematological and biochemical tests, including serum iron, TSAT, TIBC and ferritin. Data obtained from the respective centres will be entered in a Microsoft Excel sheet and analyzed using suitable statistical method. Descriptive statistics will be calculated. Categorical data will be represented in frequencies, percentages. Quantitative data will be described as Mean ± Standard Deviation (SD).
 
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