| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Heart Failure with Iron Deficiency treated with Intravenous Ferric Carboxymaltose, |
|
|
Intervention / Comparator Agent
|
|
|
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. |