A study to compare the safety and benefits of two heart failure treatments: Sacubitril-Valsartan with Dapagliflozin versus Sacubitril-Valsartan alone

Comparison of safety and efficacy of Sacubitril+ Valsartan with Dapagliflozin versus Sacubitril+ Valsartan in heart failure: A randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086281

Enrollment

120

Registered

2025-05-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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: Sacubitril-Valsartan with Dapagliflozin: Sacubitril-Valsartan-Standard drug Dosage form and strength- Tablet 50mg Type of intervention-Drug Route of administration-Oral Frequency- twice

Eligibility

Inclusion criteria

Inclusion criteria: Patients with heart failure Patients with NYHA class II to IV

Exclusion criteria

Exclusion criteria: Pregnancy and lactation Hypersensitive reactions to Sacubitril-Valsartan and Dapagliflozin Patients with history of Urinary trat infections Patients with hypotension and hyperkalemia

Design outcomes

Primary

Measure	Time frame
Reduction in number of hospitalisations and Improvement in Ejection Fraction Timepoint: Baseline and 3 months after starting therapy	—

Secondary

Measure	Time frame
Cardiovasular deathTimepoint: Baseline to 3 months;Adverse drug reactionsTimepoint: Baseline to 3 months;Improvement in quality of lifeTimepoint: Baseline and 3 months after starting therapy	—

Countries

India

Contacts

Public ContactDr Praveen Kumar

Peoples Education Society University Institute of Medical Sciences and Research

praveenbiradard@gmail.com7204456073

Outcome results

None listed

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