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Trial for Use of a drug called Intravenous Immunoglobulin in young patients with dilated heart condition

Randomized trial on use of Intravenous Immunoglobulin in young patients with recent onset dilated cardiomyopathy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011421
Enrollment
30
Registered
2018-01-18
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- Young Patients (less than 25 yrs of age) with history of dilated cardiomyopathy with onset less than 6 months before

Interventions

Intervention1: Intravenous Immnunoglobulin (IVIG): IVIG in dose of 2g/kg over 3 days will be given to patient in intervention arm along with optimal medical therapy Control Intervention1: Control Arm:

Sponsors

All india institute of medical sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with dilated cardiomyopathy with LV dysfunction 2.History s/o viral illness or myocarditis in recent past 3.Patients with recent onset of symptoms with duration 4.Patients 5.Patients giving written informed consent

Exclusion criteria

Exclusion criteria: 1.Cardiomyopathy suspected to be from following etiologies: Familial Valvular heart disease Congenital heart disease HIV/HBV/HCV infection Secondary to bacterial infection elsewhere Arrhythmia Treatment with cardiotoxic agent in past 2.Patients >25 years of age 3.Inability to comply with the follow-up period 4.Patients not giving written consent for inclusion in the trial

Design outcomes

Primary

MeasureTime frame
Improvement in LV End-diastolic dimension at 6 monthsTimepoint: at 6 months

Secondary

MeasureTime frame
To study event free survival i.e. death, hospitalization and transplant free survival at 6 monthsTimepoint: 6 months

Countries

India

Contacts

Public ContactDr Sunilkumar Verma

AIIMS, New Delhi

patilsuraj762@gmail.com8375868012

Outcome results

None listed

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