| CTRI Number |
CTRI/2025/08/093719 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
17/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of iron therapy in patients with heart failure in mild to moderate anemia. |
|
Scientific Title of Study
|
efficacy of intravenous iron therapy vs oral iron therapy on haemoglobin, exercise tolerance, cardiovascular risk and quality of life in patients having heart failure in mild to moderate iron deficiency anaemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Shikha Mundra |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research, Department of General Medicine, JNMC, Sawangi , Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
9545698866 |
| Fax |
|
| Email |
shikhamundra18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHILPA BAWANKULE |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research, Department of General Medicine, JNMC, Sawangi , Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
9673288822 |
| Fax |
|
| Email |
drshilpagaidhane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Shikha Mundra |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research, Department of General Medicine, JNMC, Sawangi , Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
9545698866 |
| Fax |
|
| Email |
shikhamundra18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Department of General Medicine ,JNMC, Sawangi , Wardha , Maharashtra, India - 442005 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research, Department of General Medicine, JNMC, Sawangi , Wardha, Maharashtra, India - 442005 |
| Type of Sponsor |
Other [Datta Meghe Institute of Higher Education and Research] |
|
|
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 Shikha Mundra |
Datta Meghe Institute of Higher Education and Research |
Department of General Medicine, Jawaharlal Nehru Medical College , Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha
Wardha
MAHARASHTRA |
9545698866
shikhamundra18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DMIHER Institutional Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I50||Heart failure, (2) ICD-10 Condition: E611||Iron deficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous iron therapy (Inj. ferric carboxymaltose) |
Drug to be administered intravenously, with the dosage calculated using Ganzonis Formula. The duration of administration will be determined based on the patients total iron deficit. |
| Comparator Agent |
Oral Iron therapy |
Drug to be administered orally with with the dosage and duration determined according to the patients total iron deficit. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with heart failure fulfilling the Framinghams criteria.
Patients with mild to moderate IDA i.e. Hb levels between 8-10 gm%.
|
|
| ExclusionCriteria |
| Details |
Patients with acute or decompensated heart failure ,severe iron deficiency anemia , aplastic anemia, anemia of chronic disease , sideroblastic anemia.
Patients with creatinine more than 2 |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study efficacy of intravenous iron therapy vs oral iron therapy in patients having heart failure with mild to moderate iron |
At baseline , 3 months and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study effect of intravenous iron vs oral iron on hemoglobin, exercise tolerance and quality of life in patients with heart failure with mild to moderate anemia. |
At baseline , 3 months and 9 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is an open-label randomized controlled trial that aims to evaluate the efficacy of intravenous (IV) iron therapy versus oral iron supplementation in heart failure (HF) patients with mild to moderate iron deficiency anemia.The study will be carried out patients who are admitted Medicine ward of Acharya Vinoba Bhave Rural Hospital (AVBRH) of Jawaharlal Nehru Medical College, Sawangi, Wardha from 2023 to 2025.Heart failure (HF) is a prevalent condition, especially among adults over 65, leading to significant morbidity and mortality. A common comorbidity in these patients is iron deficiency anemia, with prevalence estimates ranging from 4% to 30%. This comorbidity exacerbates clinical outcomes, increasing hospitalizations, impairing exercise capacity, diminishing quality of life, and elevating mortality risk. Data will be collected through face-to-face interviews with heart failure patients experiencing iron deficiency anemia at AVBRH, following written consent. Two groups will be formed: one receiving intravenous iron therapy (Inj ferric carboxymaltose) and the other oral iron therapy. Baseline assessment of Hemoglobin levels, serum ferritin, serum iron, New York Heart Association (NYHA) classification, Six-Minute Walk Test (6MWT), and quality of life evaluation using the WHOQOL-100 questionnaire and follow up will be done at 3 months and 9 months. Adverse effects will be monitored throughout the study. |