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To study Effect of injectable iron for improving quality of life and mortality in patients with heart failure with reduced ejection fraction with iron deficiency.

Effect of intravenous iron therapy in patients with heart failure with reduced ejection fraction and Iron deficiency.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043440
Enrollment
60
Registered
2022-06-22
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: I501- Left ventricular failure, unspecified

Interventions

Intervention1: Drug trial: The deficiency of iron is calculated using Ganzoni formula. The required dose is given intravenously in the form of ferric carboxymaltose, each time not more than 1000mg. If

Sponsors

PGIMER CHANDIGARH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age � 18 years. Patients with LVEF Iron deficiency, defined as either serum ferritin Patients who give consent.

Exclusion criteria

Exclusion criteria: Any clinically overt bleeding (gastrointestinal bleeding, hypermenorrhoea, history of peptic ulcer without evidence of healing or inflammatory intestinal diseases). Any inflammatory, neoplastic or infectious disease. Recent myocardial revascularization procedures. Active or metastatic neoplastic disease. Age ââ?°Â¤18 years. Patients/patientââ?¬•s attender who refuse to give consent. Unknown patients. Any contraindications to IV iron therapy Anemia not attributable to iron deficiency. Iron overload. Prior hypersensitivity reactions to intravenous iron therapy. Acute or chronic infection. Pregnancy- 1st trimester. Acute Kidney Injury. Patients with a history of severe asthma, eczema or other atopic allergy.

Design outcomes

Primary

MeasureTime frame
Change in 6-min-walk-test (6MWT) distance from baseline to Week four after IV iron therapy.Timepoint: Change in 6-min-walk-test (6MWT) distance from baseline to Week four after IV iron therapy.

Secondary

MeasureTime frame
🠶 Improvement in New York Heart Association class at 4 weeks. 🠶 Rate of HF-related or other cardiovascular hospitalizations at 12 weeks. 🠶 Time to death for any reason by 12 weeks. Timepoint: 12 weeks

Countries

India

Contacts

Public ContactSharath Chandra

PGIMER, Chandigarh

sharathdonthula333@gmail.com9642742754

Outcome results

None listed

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