| CTRI Number |
CTRI/2025/12/098700 [Registered on: 09/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of early initiation of empagliflozin drug in acute heart failure patients admitted in intensive care unit |
|
Scientific Title of Study
|
A Randomized Controlled Trial of Empagliflozin versus Placebo on Clinical, Biochemical and Outcome Markers in Critically ill ICU Patients with Acute Heart Failure |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AIMS-IEC-BAS-11-25-008 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahil Singh |
| Designation |
Senior Resident |
| Affiliation |
Amrita institute of medical sciences |
| Address |
Doctor room number 1, MICU block, 2nd floor, department of Critical care medicine, Amrita institute of medical sciences, faridabad, haryana
Faridabad
HARYANA
121002
India |
| Phone |
8901259716 |
| Fax |
|
| Email |
ssindia85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ripenmeet Salhotra |
| Designation |
Senior Consultant |
| Affiliation |
Amrita institute of medical sciences |
| Address |
Department of Critical Care Medicine, 2nd floor, Amrita institute of medical sciences, faridabad, haryana
Faridabad
HARYANA
121002
India |
| Phone |
9810390927 |
| Fax |
|
| Email |
ripenmeet.salhotra@fbd.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sahil Singh |
| Designation |
Senior Resident |
| Affiliation |
Amrita institute of medical sciences |
| Address |
Doctor room number 1, MICU block, 2nd floor, Department of Critical Care Medicine,Amrita institute of medical sciences, faridabad, haryana
Faridabad
HARYANA
121002
India |
| Phone |
8901259716 |
| Fax |
|
| Email |
ssindia85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Amrita institute of medical sciences |
| Address |
Amrita institute of medical sciences, faridabad haryana |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sahil Singh |
Amrita institute of medical sciences faridabad haryana |
Doctor room number 1 MICU block 2nd floor Department of Critical Care Medicine Amrita institute of medical sciences faridabad haryana
Faridabad
HARYANA |
8901259716
ssindia85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee, Amrita Hospital, Faridabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 placebo to other group on randomization basis and then will assess the improvement in net negative fluid balance in acute heart failure patients |
| Comparator Agent |
Empagliflozin versus placebo to be given to acute heart failure patients |
We will assess the improvement in net negative fluid balance in acute heart failure patients ,risk of rehospitalization and mortality at day 30 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 18 years and above hospitalized with primary diagnosis of acute de novo heart failure or decompensated chronic heart failure |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcomes-
Cumulative net fluid balance at day 3
|
Primary Outcomes-
Cumulative net fluid balance at day 3
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
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
|
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We designed the present study to address the critical evidence gap by evaluating the clinical, biochemical and outcome effects of early empagliflozin initiation in patients with acute heart failure in the intensive care unit.
Patient will be then included in the study after fulfilling the inclusion and exclusion criteria. Patient will be enrolled within 24 of admission in ICU after block randomization. Patients will be randomized in a 1:1 ratio to the empagliflozin and placebo arms using a computer-generated randomization sequence. The sequence will be created locally using permuted blocks of four to ensure balanced allocation while maintaining allocation concealment. The randomization list will be prepared by a study investigator not involved in patient enrolment or treatment. Allocations will be placed in sequentially numbered, opaque, sealed envelopes, which will be opened only after the participant is deemed eligible and consented to trial. Treating clinicians and outcome assessors will have no access to the randomization sequence. Patient will receive the standard management for acute heart failure along with empagliflozin 10mg once daily per oral and placebo (vitamin C tablet) as per intensivist and cardiologist decision. Strict fluid balance charting will be done during entire ICU stay. Dyspnea VAS will be assessed within 24 hour of admission and at day 3. Duration and modality of respiratory support will be noted. Need for vasopressor support and dialysis will be assessed. Intervention will be stopped in case of adverse effects, if any as per treating clinician decision. Total dose of diuretics received in ICU will be noted. NT proBNP levels will be done at admission and day 3. Patient will be followed for 30 days post discharge from hospital. Duration of treatment will be decided as per treating physician post discharge.
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