Effect of Ferric carboxymaltose in patients with Chronic Heart failure with Iron deficiency anaemia

Not Applicable

Completed

• Conditions: Health Condition 1: I509- Heart failure, unspecified

• Registration Number: CTRI/2021/02/031307
• Lead Sponsor: Emcure Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-08-26
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 98

Inclusion Criteria

1.Indian adult ( > 18 years of age) patients of either gender who are capable of complying with

study protocol requirements.

2. Stable symptomatic ambulatory patients diagnosed with chronic heart failure of New York Heart Association (NYHA) class II â?? III and iron deficiency. Iron deficiency is diagnosed whenthe serum ferritin level is lessthan 100 μg/L or is between 100 and 299 μg/L when the transferrin saturation (TSAT) is less than 20%.

3. Patients ready to give informed consent for participation in study.

Exclusion Criteria

1. Patients not willing to sign Informed Consent Form and provide medical data.

2. Hypersensitivity to ferric carboxymaltose injection.

3. Participation in any other clinical trial in the past 3 months.

4. Treatment with other IV Iron preparations within 4 weeks prior to study enrolment.

5. Any condition that, in the opinion of the investigator, does not justify the patientâ??s inclusion in the study.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the New York Heart Association (NYHA) class from baseline at Week 12 (+1 week).Timepoint: 12 weeks