FindTrial
Sign In

A Study of ferric carboxymaltose treated chronic heart failure patients lacking iron

Assessment of Clinical Profile of Patients of Chronic Heart Failure with Iron Deficiency Treated with Intravenous Ferric Carboxymaltose 1000 mg:- PRIDE-HF India Study - PRIDE-HF India

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/02/011933
Enrollment
2000
Registered
2018-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Chronic Heart Failure with Iron Deficiency treated with Intravenous Ferric Carboxymaltose

Interventions

None listed

Sponsors

Emcure Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 â?? 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Demographic and clinical profile of patients of chronic heart failure with iron deficiency treated with I.V. FCM 1000 mgTimepoint: Single visit—

Secondary

MeasureTime frame
Mean serum ferritin levels in patients with transferrin saturation (TSAT) more than 20% at the initiation of treatment with inj FCMTimepoint: Single visit;Mean serum ferritin levels in patients with TSAT less than 20% at the initiation of treatment with inj FCMTimepoint: 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)Timepoint: Single visit;Percentage of patient with chronic heart failure with preserved ejection fraction (HFpEF) and iron deficiencyTimepoint: Single visit;Percentage of patient with chronic heart failure with reduced ejection fraction (HFrEF) and iron deficiencyTimepoint: Single visit;Percentage of patients with various New York Heart Association (NYHA) classes of HFTimepoint: Single visit—

Countries

India

Contacts

Public ContactDr Shahu Ingole

Emcure Pharmaceuticals Ltd

Shahu.Ingole@emcure.co.in9689886691

Outcome results

None listed

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