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CTRI Number  CTRI/2021/02/031307 [Registered on: 16/02/2021] Trial Registered Prospectively
Last Modified On: 03/05/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Effect of Ferric carboxymaltose in patients with Chronic Heart failure with Iron deficiency anaemia 
Scientific Title of Study   Prospective ObseRvational Study to Assess Effectiveness and Safety of Intravenous Ferric Carboxymaltose 1000 mg in Patients of Chronic Heart Failure with Iron DeficiEncy - PRIDE-HF Study 
Trial Acronym  PRIDE-HF 
Secondary IDs if Any  
Secondary ID  Identifier 
EPL/FCM/20/OO1 v2.0 dated 7th Jan 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajendra Kumar Premchand 
Designation  Consultant Interventional Cardiologist and Head 
Affiliation  Krishna Institute of Medical Sciences 
Address  Department of Cardiology, Block 3, 3rd floor, room no. 59 Krishna Institute of Medical Sciences 83 1 1 Minister road Secunderabad 500003 Telangana India

Hyderabad
TELANGANA
500003
India 
Phone  9848029443  
Fax    
Email  kumarpre@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Onkar Swami 
Designation  Director Medical Services 
Affiliation  Emcure Pharmaceuticals Limited 
Address  Emcure Pharmaceuticals Ltd. Phase-1, Rajiv Gandhi IT Park, M.I.D.C. Hinjwadi, Pune - 411057. India

Pune
MAHARASHTRA
411057
India 
Phone  9372413101  
Fax    
Email  Onkar.Swami@emcure.co.in  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Sanket Newale 
Designation  DGM Medical services 
Affiliation  Emcure Pharmaceuticals Limited 
Address  Phase-1, Rajiv Gandhi IT Park, M.I.D.C. Hinjwadi, Pune - 411057. India

Pune
MAHARASHTRA
411057
India 
Phone  9167116860  
Fax    
Email  Sanket.Newale@emcure.co.in  
 
Source of Monetary or Material Support  
Emcure Pharmaceuticals Ltd. 
 
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
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajesh Badani  Aditya Birla Memorial Hospital  First Floor, Department of Cardiology, Aditya Birla Hospital Marg,Thergaon, Chinchwad, Pune- 411033
Pune
MAHARASHTRA 		 9823818400

badani_rajesh@yahoo.co.in 
Dr Rajendra Kumar Premchand  Krishna Institute of Medical Sciences  Block 3, 3rd floor, room no. 59 1-8-31/1, Minister road, Secunderabad 500003, Telengana
Hyderabad
TELANGANA 		 9848029443

kumarpre@hotmail.com 
Dr Bagirath Raghuraman  Narayana Institute of Cardiac Sciences  Department of cardiology, Room no. 9 ground floor. 258/A, Bommasandra Industrial area, Anekal taluk, Bangalore
Bangalore
KARNATAKA 		 9845144830

bagirath.raghuraman.dr@narayanahealth.org 
Dr Sachin Narendra Patil  Sachin Super speciality clinic  Room No. 2 Sachin Super Speciality Clinic, 2nd Floor, Rajarampuri 6th lane, Near Shri Ram High school Kolhapur -416008
Kolhapur
MAHARASHTRA 		 9225068519

snp9991@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Aditya Birla Memorial Hospital Ethics Committee  Approved 
Aster Aadhar ethics committee  Approved 
KIMS ethics committee  Approved 
Narayana Health Medical 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 
Intervention  Injection Ferric Carboxymaltose  Dose will be based on the patient weight and Hb level. Given at baseline followed by a repeat dose after 4 weeks if needed.  
Comparator Agent  Not applicable  Not applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Indian adult (> 18 years of age) patients of either gender who are capable of complying with
study protocol requirements.
2. Stable symptomatic ambulatory patients diagnosed with chronic heart failure of New York Heart Association (NYHA) class II – III and iron deficiency. Iron deficiency is diagnosed whenthe serum ferritin level is lessthan 100 μg/L or is between 100 and 299 μg/L when the transferrin saturation (TSAT) is less than 20%.
3. Patients ready to give informed consent for participation in study. 
 
ExclusionCriteria 
Details  1. Patients not willing to sign Informed Consent Form and provide medical data.
2. Hypersensitivity to ferric carboxymaltose injection.
3. Participation in any other clinical trial in the past 3 months.
4. Treatment with other IV Iron preparations within 4 weeks prior to study enrolment.
5. Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in the New York Heart Association (NYHA) class from baseline at Week 12 (+1 week).  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Mean self-reported PGA score, health-related QOL score
 		 12 weeks 
Mean change in health-related quality of life [to be evaluated using Minnesota Living with Heart Failure Questionnaire Score] score  12 weeks 
Number and nature of serious and non-serious adverse events throughout study duration.  12 weeks 
Rate of any hospitalization, rate of hospitalization for any cardiovascular reason, and rate of hospitalization due to worsening HF  12 weeks 
Time to first hospitalization for any reason, time to first hospitalization for any cardiovascular reason and time to first hospitalization due to worsening HF   12 weeks 
Mean change in the haematological parameters [serum ferritin, Haemoglobin (Hb), Total Iron Binding Capacity (TIBC) and Transferrin Saturation (TSAT)]  Week 4 and 12 
Change in the New York Heart Association (NYHA) class, mean self-reported PatientGlobal Assessment (PGA) score and mean change in health-related quality of life [to be evaluated using Minnesota Living with Heart Failure Questionnaire Score] score  4 weeks 
Change in the 2D Echocardiography findings & Ejection Fraction (%)  Week 4 and 12 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "98"
Final Enrollment numbers achieved (India)="98" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/02/2021 
Date of Study Completion (India) 26/08/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
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   In patients with chronic diseases, especially those having complex inflammatory disorder, a multidisciplinary approach is needed to maintain quality of life (QoL) and improve clinical outcomes. Iron deficiency is one such clinical condition which affects more than 2 billion people globally. Ferric carboxymaltose (FCM) is used for rapid and high-dose replenishment of depleted iron stores. The proposed study is a non-interventional observational study which aims to collect data reflecting the real-world experience with Ferric carboxymaltose (FCM) in the post-approval setting to expand their understanding of its clinical effectiveness and safety in patients with stable chronic heart failure with anaemia. Data will be collected in about hundred patients from multiple centers. Patients will be followed for 12 weeks to collect information on improvement in symptoms, cardiac function, quality of life, adverse events etc. 
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