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Safety and efficacy of sacubitril/valsartan in patients with congenital heart diease with systemic right ventricular dysfunction – a prospective observational study

Safety and efficacy of sacubitril/valsartan for systemic right ventricular dysfunction – a prospective observational study - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/02/063203
Enrollment
75
Registered
2024-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: I508- Other heart failure

Interventions

Intervention1: Sacubitril/Valsartan: Drug used for treatment of heart failure Intervention2: nil: nil Control Intervention1: NIL: NIL

Sponsors

Pediatric Cardiac Society of India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: After obtaining written informed consent, all consecutive patients with systemic right ventricular dysfunction, ie, systemic right ventricular ejection fraction (sRV EF) =40% or fractional area change (FAC) =35%, assessed by ECHO would be included.

Exclusion criteria

Exclusion criteria: 1. Univentricular physiology 2. Systolic blood pressure 3. GFR 4. Serum potassium > 5.5 mEq/L 5. Previous intolerance to ACEi/ARB/ARNI

Design outcomes

Primary

MeasureTime frame
Proportion of patients achieving systemic right ventricular ejection fraction > 40% or fractional area change >35% Timepoint: 18 months—

Secondary

MeasureTime frame
Improvement in NYHA/Ross functional classTimepoint: 18 MONTHS;Proportion of patients achieving the target dose of sacubitril/valsartan at 3months and 12months Timepoint: 3 months and 12 months;Safety of sacubitril/valsartan as assessed by blood pressure, renal function test, serum electrolytes Timepoint: 18 MONTHS—

Countries

India

Contacts

Public ContactDr Punitha Lakxmi Ramesh

Sree Chitra Tirunal Institute For Medical Science And Technology

kmkm@sctimst.ac.in9447239424

Outcome results

None listed

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