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Early ACE inhibitor use in children with medium sized ventricular septal defects with congestive heart failure: A single-center randomized trial

Assessment of efficacy of early introduction of ACE (angiotensin converting enzyme) inhibitors in treatment of congestive heart failure in children with medium sized ventricular septal defects: a single center open label randomized trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070332
Enrollment
48
Registered
2024-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: I509- Heart failure, unspecified

Interventions

Intervention1: Early introduction of ACE (angiotensin converting enzyme) inhibitor - enalapril: Furosemide at dose of 2 mg/kg/day q12hr through oral route
Enalapril at dose of 0.1 mg/kg/day q24hr through oral route started within 24 hours of starting furosemide The drug Enalapril and Furosemide which will be used in intervention group are established a

Sponsors

All India Institute of Medical Sciences, Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children aged 1 month to 10 years of either sex with medium sized VSD (diagnosed by 2D echo) presenting with congestive heart failure

Exclusion criteria

Exclusion criteria: i. Patients already on enalapril ii. Patients who have already undergone surgical correction of VSD iii. Patients with small and large sized VSD iv. Patients with renal dysfunction or hyperkalemia v. Patients with cardiogenic shock

Design outcomes

Primary

MeasureTime frame
Resolution of respiratory distress (based on respiratory rate (/min) (resolution of tachypnea), retractions – subcostal/intercostal/suprasternal, nasal flaring and grunting).Timepoint: 1 week and 1 month after starting intervention

Secondary

MeasureTime frame
i. Resolution of signs of heart failure – regression of liver size below right costal margin (in cm) and difference in liver span (in cm) ii. Number of admissions and total days of admission iii. Recurrence of respiratory distress – tachypnea or retractions (assess at 1 week and 1 month)Timepoint: 1 week and 1 month after starting intervention

Countries

India

Contacts

Public ContactDr Chandra Raj Datta

All India Institute of Medical Sciences, Patna

drarunp@aiimspatna.org9472140820

Outcome results

None listed

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