A study comparing two medicines, Dapagliflozin and Empagliflozin, in patients with heart failure to see which works better and is safer.

A Randomized Open Label Trial to Compare the Efficacy and Safety of Dapagliflozin and Empagliflozin in Heart Failure Patients Attending a Tertiary Care Centre in Puducherry - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092575

Enrollment

Registered

2025-08-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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: Nil: Nil Intervention2: Empagliflozin: Empagliflozin 10mg orally once daily, administered in addition to standard heart failure therapy for 1 year Intervention3: Nil: Nil Control Interv

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older who consents to participate in the study. Patients with newly diagnosed heart failure and who already diagnosed with HF but not receiving SGLT2 inhibitors. Patients with or without co-morbidities

Exclusion criteria

Exclusion criteria: Patients with type 1 diabetes mellitus. Patients with HbA1c more than 10 percent. Severe renal impairment (eGFR less than 30mL per min per 1.73m ). History of diabetic ketoacidosis. History of allergic reactions to SGLT2 inhibitors. History of active genitourinary tract infection. Pregnancy or Lactation.

Design outcomes

Primary

Measure	Time frame
The primary outcomes of this study are twofold. First, the comparative effect of Dapagliflozin and Empagliflozin on reducing cardiovascular mortality and hospitalization due to heart failure will be assessed. Second, echocardiographic improvements will be evaluated by comparing Left Ventricular Ejection Fraction (LVEF), Left Atrial Volume Index (LAVi), and Left Ventricular End-Diastolic Diameter (LVEDD) between the two groups.Timepoint: At baseline, 6 months and 12 months.	—

Measure

Time frame

The primary outcomes of this study are twofold. First, the comparative effect of Dapagliflozin and Empagliflozin on reducing cardiovascular mortality and hospitalization due to heart failure will be assessed. Second, echocardiographic improvements will be evaluated by comparing Left Ventricular Ejection Fraction (LVEF), Left Atrial Volume Index (LAVi), and Left Ventricular End-Diastolic Diameter (LVEDD) between the two groups.Timepoint: At baseline, 6 months and 12 months.

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Secondary

Measure	Time frame
The secondary outcomes involve assessing the improvement in functional status based on the New York Heart Association (NYHA) functional classification, measured at baseline and at 6 months and 12 months. Adverse effects will be monitored throughout 1 year, including the incidence of genitourinary infections and other reported events. Renal function tests (serum creatinine and estimated GFR) and serum electrolytes (sodium and potassium) will be evaluated at baseline, at 6 months, and at 12 months.Timepoint: At baseline, 6 months and 12 months.	—

Measure

Time frame

The secondary outcomes involve assessing the improvement in functional status based on the New York Heart Association (NYHA) functional classification, measured at baseline and at 6 months and 12 months. Adverse effects will be monitored throughout 1 year, including the incidence of genitourinary infections and other reported events. Renal function tests (serum creatinine and estimated GFR) and serum electrolytes (sodium and potassium) will be evaluated at baseline, at 6 months, and at 12 months.Timepoint: At baseline, 6 months and 12 months.

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Countries

India

Contacts

Public ContactDr Geerthana Thamizhvanan

Sri Venkateshwaraa Medical College Hospital and Research Centre

saisashe05@gmail.com9003679174

Outcome results

None listed

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