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CTRI Number  CTRI/2018/02/011933 [Registered on: 16/02/2018] Trial Registered Prospectively
Last Modified On: 16/02/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study of ferric carboxymaltose treated chronic heart failure patients lacking iron 
Scientific Title of Study   Assessment of Clinical Profile of Patients of Chronic Heart Failure with Iron Deficiency Treated with Intravenous Ferric Carboxymaltose 1000 mg:- PRIDE-HF India Study 
Trial Acronym  PRIDE-HF India 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shahu Ingole 
Designation  Deputy General Manager 
Affiliation  Emcure Pharmaceuticals Ltd 
Address  Survey No. 255/2, Rajiv Gandhi IT Park, MIDC, Hinjwadi, Pune

Pune
MAHARASHTRA
411057
India 
Phone  9689886691  
Fax    
Email  Shahu.Ingole@emcure.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shahu Ingole 
Designation  Deputy General Manager 
Affiliation  Emcure Pharmaceuticals Ltd 
Address  Survey No. 255/2, Rajiv Gandhi IT Park, MIDC, Hinjwadi, Pune


MAHARASHTRA
411057
India 
Phone  9689886691  
Fax    
Email  Shahu.Ingole@emcure.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Shahu Ingole 
Designation  Deputy General Manager 
Affiliation  Emcure Pharmaceuticals Ltd 
Address  Survey No. 255/2, Rajiv Gandhi IT Park, MIDC, Hinjwadi, Pune


MAHARASHTRA
411057
India 
Phone  9689886691  
Fax    
Email  Shahu.Ingole@emcure.co.in  
 
Source of Monetary or Material Support  
Emcure Pharmaceuticals Ltd Survey No. 255/2, Rajiv Gandhi IT Park, MIDC, Hinjwadi, Pune - 411 057, Maharashtra, India. 
 
Primary Sponsor  
Name  Emcure Pharmaceuticals Ltd 
Address  Survey No. 255/2, Rajiv Gandhi IT Park, MIDC, Hinjwadi,Pune 
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 Jamshed Dalal  Kokilaben Dhirubhai Ambani Hospital  Department of Cardiology,Centre for Cardiac Sciences,Kokilaben Dhirubhai Ambani Hospital, Rao Saheb Achutrao Patwardhan Marg, Four Bunglows, Andheri (W), Mumbai - 400053
Mumbai
MAHARASHTRA 
9821012409

jjdalal@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee Dhanashree Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Heart Failure with Iron Deficiency treated with Intravenous Ferric Carboxymaltose,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 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 ambulatory patients with chronic heart failure of New York Heart Association (NYHA) class I – IV and iron
deficiency. Iron deficiency is diagnosed when the serum ferritin level is less than 100 μg/L or is between 100 and 299
μg/L when the transferrin saturation (TSAT) is less than 20%
3. Patients treated with injection ferric carboxymaltose 1000 mg as per approved prescribing information.
4. Patients whose ejection fraction, serum ferritin and Hb levels are available at the start of FCM therapy. 
 
ExclusionCriteria 
Details  1. Patients with incomplete health record as per the requirement of protocol
2. Patients not willing to sign Informed Consent Form and provide medical data
3. Pregnant and lactating women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Demographic and clinical profile of patients of chronic heart failure with iron deficiency treated with I.V. FCM 1000 mg  Single visit 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of patient with chronic heart failure with reduced ejection fraction (HFrEF) and iron deficiency  Single visit 
Percentage of patient with chronic heart failure with preserved ejection fraction (HFpEF) and iron deficiency  Single visit 
Percentage of patients with various New York Heart Association (NYHA) classes of HF  Single visit 
Percentage of patient with chronic heart failure and iron deficiency anemia (defined as Hb less than 13 g/dL in male and Hb
less than 12 g/dL in female) 
Single visit 
Mean serum ferritin levels in patients with transferrin saturation (TSAT) more than 20% at the initiation of treatment
with inj FCM 
Single visit 
Mean serum ferritin levels in patients with TSAT less than 20% at the initiation of treatment with inj FCM  Single visit 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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   N/A 
Date of First Enrollment (India)   26/02/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Iron deficiency is estimated to affect 37–61% of patients with chronic heart failure (CHF). The diagnosis of iron deficiency in CHF is complicated by the fact that the key manifestations of CHF (fatigue, exercise intolerance) are the same as those of iron deficiency (ID). In CHF, iron deficiency has been shown to adversely impact exercise capacity and quality of life independently of anemia and predicts worse outcomes. ID has shown to be an independent predictor of mortality in patients with CHF. Iron deficiency, regardless of haemoglobin level, is an indication for iron supplementation in symptomatic patients As limited data is available on clinical profile of Indian patients of CHF with iron deficiency who are treated with intravenous ferric carboxymaltose (IV FCM), this study has been planned. The objective of this study is to understand the disease profile and clinical profile of patients diagnosed with CHF with iron deficiency and treated with IV FCM 1000 mg. The study design will be a cross-sectional, multi-centre, non-interventional study of adult Indian patients diagnosed with chronic heart failure with iron deficiency and prescribed with injection ferric carboxymaltose 1000 mg as per approved prescribing information. During screening of the patients, those found to be eligible as confirmed by inclusion/exclusion criteria will be enrolled into the study. Those willing to participate and provide their health record for the purpose of study will be asked to sign the Informed Consent Form. 
Patient’s demographic characteristics, disease profile, significant medical history, treatment details and concomitant medications details will be recorded by the Investigator in the Case Report Form (CRF). No examination or investigations beyond that normally required in routine clinical practice are needed to be done for the purpose of this study. No follow-up of the patients will be done. Patient’s ejection fraction, serum ferritin, transferrin saturation, Hemoglobin done at the time of initiation of treatment with injection ferric carboxymaltose will also be recorded in to CRF.
 
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