To study the effect of early initiation of empagliflozin drug in acute heart failure patients admitted in intensive care unit

A Randomized Controlled Trial of Empagliflozin versus Placebo on Clinical, Biochemical and Outcome Markers in Critically ill ICU Patients with Acute Heart Failure - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098700

Enrollment

Registered

2025-12-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Administration of empagliflozin drug to 1 group along with standard care and placebo with standard care to other group: We will administer empaglifozin 10 mg once daily to one group and

Eligibility

Inclusion criteria

Inclusion criteria: Patients of age 18 years and above hospitalized with primary diagnosis of acute de novo heart failure or decompensated chronic heart failure

Exclusion criteria

Exclusion criteria: Hypotension requiring vasopressor support Type 1 diabetes Chronic kidney disease and Acute kidney injury requiring dialysis Already on SGLT 2 inhibitor treatment Known hypersensitivity or intolerance to drug Patient with documented alcohol abuse Pregnancy/ lactation Refused for participation in study

Design outcomes

Primary

Measure	Time frame
Primary Outcomes- Cumulative net fluid balance at day 3 Timepoint: Primary Outcomes- Cumulative net fluid balance at day 3	—

Secondary

Measure	Time frame
Secondary Outcomes- Safety and tolerability Total cumulative dose of intravenous diuretics (in furosemide equivalents) required over first 3 days Change in dyspnea VAS over 3 days Relative change in NT pro BNP levels at day 3 ICU length of stay (days) All-cause mortality/rehospitalization for heart failure at day 30 Timepoint: Secondary Outcomes- Safety and tolerability Total cumulative dose of intravenous diuretics (in furosemide equivalents) required over first 3 days Change in dyspnea VAS over 3 days Relative change in NT pro BNP levels at day 3 ICU length of stay (days) All-cause mortality/rehospitalization for heart failure at day 30	—

Measure

Time frame

Secondary Outcomes- Safety and tolerability Total cumulative dose of intravenous diuretics (in furosemide equivalents) required over first 3 days Change in dyspnea VAS over 3 days Relative change in NT pro BNP levels at day 3 ICU length of stay (days) All-cause mortality/rehospitalization for heart failure at day 30 Timepoint: Secondary Outcomes- Safety and tolerability Total cumulative dose of intravenous diuretics (in furosemide equivalents) required over first 3 days Change in dyspnea VAS over 3 days Relative change in NT pro BNP levels at day 3 ICU length of stay (days) All-cause mortality/rehospitalization for heart failure at day 30

—

Countries

India

Contacts

Public ContactSahil Singh

Amrita institute of medical sciences

ripenmeet.salhotra@fbd.amrita.edu9810390927

Outcome results

None listed

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