Trial for Use of a drug called Intravenous Immunoglobulin in young patients with dilated heart conditio
Phase 3
- 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
- Registration Number
- CTRI/2018/01/011421
- Lead Sponsor
- All india institute of medical sciences New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 < 6 months
4.Patients <25 years of age
5.Patients giving written informed consent
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in LV End-diastolic dimension at 6 monthsTimepoint: at 6 months
- Secondary Outcome Measures
Name Time Method To study event free survival i.e. death, hospitalization and transplant free survival at 6 monthsTimepoint: 6 months