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Comparison of Dapagliflozin and Sacubutril-Valsartan in heart failure

Efficacy and safety of dapagliflozin vs sacubitril/valsartan among patients of heart failure with reduced ejection fraction: A randomized study. - NO

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060772
Enrollment
100
Registered
2023-12-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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: Dapagliflozin: Patient in dapaglilflozin will be given the dosage 10 mg and will be escalated as per physician discretion. Control Intervention1: Sacubitril Valsartan: Patient in the Sa

Sponsors

All India Institute Of Medical Sciences, Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients Age 18 year to 75 years of either sex. 2. Left Ventricular ejection fraction 3. Patient having Heart failure belonging to NYHA class II-III

Exclusion criteria

Exclusion criteria: 1.Patient having Acute decompensated Heart failure. 2.Patient who have eGFR 3.Patient with history of intolerance to SGLT-2 inhibitor or ARNI (Angiotensin receptor-neprilysin inhibitor) 4.Patients having AST/ALT =3 times of normal range 5.Pregnant and lactating women. 6.Patient with recurrent Urinary Tract Infections. 7.Patient having recent Pyelonephritis.

Design outcomes

Primary

MeasureTime frame
Mean change in NT-proBNP from baseline to 16 weeks.Timepoint: baseline, 4th week and 16 th week

Secondary

MeasureTime frame
1.Mean change in Kansas City Cardiomyopathy Questionnaire (KCCQ) points from baseline to 16 weeks 2.Mean change in eGFR, GDF-15 and ECHO findings (Left ventricular ejection fraction, End diastolic volume) from baselines to 16 weeks 3.Cost Needed to Treat (CNT) to prevent one event of CVD. 4. Safety analysis between the two groups. Timepoint: baseline, 4th week , 16 th week

Countries

India

Contacts

Public ContactDr Krishna Tiwari

All India Institute Of Medical Sciences,Jodhpur

drshobanpgimer@gmail.com8437726777

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026