Comparison of Metaprolol and Bisoprolol with Dapagliflozin in patients with Heart Failure.

Comparative Evaluation of Metaprolol Succinate-Dapagliflozin versus Bisoprolol Fumarate-Dapagliflozin on NT-proBNP level in Heart Failure with reduced Ejection Fraction [HFrEF] Patients: A Randomized Open Label Prospective Study. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/096770

Enrollment

Registered

2025-11-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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: Bisoprolol Fumarate + Dapagliflozin: Bisoprolol Fumarate (1.25-10mg) + Dapagliflozin (10mg) OD for 12 weeks Beta blockers titrated to maximum tolerated dose Control Intervention1: Metop

Eligibility

Inclusion criteria

Inclusion criteria: Patient aged 18-80 years with diagnosed HFrEF greater than or equal to 1month, Left ventricular Ejection Fraction lesser than or equal to 40%, NYHA Functional Class II or above, NT-proBNP Level concentration greater than or equal to 600pg/ml, Stable on standard Guideline-directed medical therapy, patient willing and able to provide written informed consent will be included.

Exclusion criteria

Exclusion criteria: Symptomatic hypotension or Systolic blood pressure less than 95mmHg, Recent diagnosis with Myocardial Infarction, Unstable Angina, stroke or Transient ischemic attack, Patient with Type 1 Diabetes mellitus or Diabetic Keto Acidosis, Previous history of Urinary Tract infection, Lactating and pregnant women, Contraindications to beta blockers or dapagliflozin, eGFR lesser than or equal to 30 mL/min/1.73 m will be excluded.

Design outcomes

Primary

Measure	Time frame
To Compare the efficacy of two commonly used Beta blockers (Metoprolol succinate and Bisoprolol fumarate) in combination with Dapagliflozin on NT-proBNP level in improving Left Ventricular Ejection Fraction [LVEF] among Heart Failure with reduced ejection fraction [HFrEF] patients.Timepoint: ECHO: Week 0, Week 6,Week 12 NTproBNP: Week 0 and Week 12	—

Secondary

Measure	Time frame
To access the quality of life of the patient during the study period using Health Related Quality of Life [HRQOL] Questionnaire, To identify the incidence of adverse events (if any) during the study period, To evaluate treatment adherence and compliance at every follow ups. Timepoint: HRQOL questionnaire: Week 6	—

Countries

India

Contacts

Public ContactMs Hindhusha K V

SRM Institute of Science and Technology, Kattankulathur

jagadeem1@srmist.edu.in7449277556

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026