| CTRI Number |
CTRI/2024/09/074098 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Iron therapy in heart failure |
|
Scientific Title of Study
|
Comparative outcomes of intravenous versus oral iron supplementation in acute decompensated heart failure |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinod kumar |
| Designation |
Post graduate junior resident |
| Affiliation |
Government Medical College and Hospital Chandigarh Sector32 |
| Address |
D Block level 4th medicine office GMCH Chandigarh Sector 32,160030
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8492947163 |
| Fax |
|
| Email |
vinodploch222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monica Gupta |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital Chandigarh Sector32 |
| Address |
Room No. D-463, D Block level Department of General Medicine,
Government Medical College and Hospital, Sector 32, Chandigarh
Pin: 160030
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121558 |
| Fax |
|
| Email |
drmg1156@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinod kumar |
| Designation |
Post graduate junior resident |
| Affiliation |
Government Medical College and Hospital Chandigarh Sector32 |
| Address |
D Block level 4th medicine office GMCH Chandigarh Sector 32,160030
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8492947163 |
| Fax |
|
| Email |
vinodploch222@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT MEDICAL COLLEGE AND HOSPITAL CHANDIGARH SECTOR 32, 160030 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh Sector |
| Address |
Sector 32 Chandigarh , 160030 |
| Type of Sponsor |
Government medical college |
|
|
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 Vinod Kumar |
Government Medical College and Hospital, Sector 32, Chandigarh, India |
Department of General Medicine, Room No. D-463, D-BLOCK, LEVEL-4
Chandigarh
CHANDIGARH |
8492947163
-
vinodploch222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE (GMCH CHANDIGARH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I509||Heart failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous iron (ferric carboxymaltose) |
In intervention arm, patients of acute decompensated heart failure will receive single dose of intravenous ferric carboxymaltose (FCM)solution
Dose: 500-1000 mg of FCM will be administered as 100 ml of diluted injection over 30 min. |
| Comparator Agent |
Oral iron tablet (100 mg elemental iron per day) |
In control arm, patients of acute decompensated heart failure will receive daily one dose of oral iron tablet (100 mg elemental iron per day) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Hospitalized patients with acute decompensated heart failure irrespective of LVEF.
2.Patients with iron deficiency.
3.Patients able to complete six minute walk test ( 6MWT).
4.Individuals above 18 years of age.
|
|
| ExclusionCriteria |
| Details |
1.Serum ferritin concentrations above 400
microgram/dl.
2.Hemoglobin concentration less than 9 gram/dl.
3.Known sensitivity to ferric carboxy maltose.
4.Blood transfusions, intravenous iron therapy, or
erythropoetin therapy within 3 months prior to
enrolment.
5.Myocardial infarction in last 90 days.
6.Complex cyanotic congenital heart diseases.
7.Severe concomitant conditions like chronic
kidney disease,renal dialysis, chronic lung
disease chronic liver disease.
8.Hemolytic anemia or myelodysplastic order or
abnormalities in iron storage such as
hemochromatosis.
9.Recognized hematological, malignant or other
active neoplasia.
10.Chemotherapy, radiation, or other
immunosuppressive medication within three
months of enrolment.
11.Pregnant women.
12.Serious medical conditions that the
investigators determine make it impossible for
participants to complete the trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in new york heart
association (NYHA)
functional class at 3 and 6 months.
2.Change in ejection fraction
( by 2d ECHO ) at 6 months.
3.Change in 6MWT distance at 6
months .
4.Change in QOL as assessed by
the Minnesota living with
heart failure at 6 months .
5.Emergency revisit due to
ADHF.
6.Six months readmission due
to ADHF.
7.Six month mortality due to
ADHF.
8.Six month mortality due to
all cardiovascular causes
|
At baseline , 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/10/2024 |
| Date of Study Completion (India) |
20/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Heart failure represents a progressive clinical state characterized by significant morbidity and mortality .Iron deficiency , often accompanied by or independent of anemia, is prevalent among heart failure patients. Iron deficiency impacts prognosis, physical well being , exercise intolerance , hospitalization recurrence , and mortality rates.Clinical evidence form various large trials showed that parentral iron therapy for the correction of ID in patients with heart failure has a positive impact on morbidity , including functional improvement in QOL and HRQOL , 6MWT. We therefore plan to conduct an experimental study involving hospitalized patients with ADHF to evaluate the role of single dose parentral iron therapy prior to discharge in those patients who are found to have concurrent Iron deficieny. Comparing to other interventional trials , our study will use a simple dosing regimen of single dose parentral iron in addition to oral iron supplementation in iron deficient non- anemic patients with ADHF reagrdless of their LVEF. |