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Spectrum Of Use Of Ferric Carboxymaltose In Heart Failure Patients

Spectrum Of Use Of Ferric Carboxymaltose In Heart Failure Patients With New York Heart Association Functional Class II And III

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043343
Enrollment
180
Registered
2022-06-20
Start date
Unknown
Completion date
Unknown
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E611- Iron deficiency

Interventions

Intervention1: Ferric carboxymaltose: Ferric carboxy maltose, 1gram in 100ml 0.9% NS for a period of 45 mins.

Sponsors

Bharat Institute of Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who provide consent and present with NYHA II-III functional class due to stable symptomatic heart failure (HF) Left ventricular ejection fraction (LVEF) 40% or lower for patients in NYHA II and 45% or lower in NYHA III. Serum ferritin below 100 µg/L, or below 200 µg/L when transferrin saturation (TSAT) is below 20%

Exclusion criteria

Exclusion criteria: If the patient is not willing to provide consent. Known active infection, clinically significant bleeding, active malignancy. Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) Anaemia due to reasons other than iron deficiency Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months). History of erythropoietin, I.V or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months. Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias. Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months. Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.

Design outcomes

Primary

MeasureTime frame
IMPROVEMENT IN HEMOGLOBINTimepoint: 3 Months

Secondary

MeasureTime frame
QUALITY OF LIFETimepoint: 3 months

Countries

India

Contacts

Public ContactBavu Akhilkumar

Krishna Institute of Medical Sciences

shibnath007@gmail.com9951166479

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026