| CTRI Number |
CTRI/2025/07/090566 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of a Heart Medicine named Dapagliflozin to Reduce Death and Repeat Hospital Visits in Heart Failure Patients |
|
Scientific Title of Study
|
Evaluation the efficacy of early treatment with dapagliflozin in acute heart failure patients presenting to the emergency department- A randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sourav Paul |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Internal Medicine, Level 4, F Block, Nehru Hospital, Postgraduate Institution of Medical Education and Research, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7908618591 |
| Fax |
|
| Email |
souravpaul7598@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh C Sharda |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Internal Medicine, Level 4, F block, Nehru Hospital, Postgraduate Institution of Medical Education and Research, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722756670 |
| Fax |
|
| Email |
saurabhcsharda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh C Sharda |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Internal Medicine, Level 4, F block, Nehru Hospital, Postgraduate Institution of Medical Education and Research, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722756670 |
| Fax |
|
| Email |
saurabhcsharda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Special Research Thesis Grant, Department of Internal Medicine, Level 4, F block, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012, India |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research |
| Address |
Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012, India |
| Type of Sponsor |
Government 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 |
| Dr Sourav Paul |
Postgraduate Institute of Medical Education and Research, Chandigarh |
Department of Internal Medicine, Level 4, F block, Nehru Hospital, Postgraduate Institution of Medical Education and Research, Sector 12
Chandigarh
CHANDIGARH |
7908618591
souravpaul7598@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I95-I99||Other and unspecified disorders of the circulatory system, (2) ICD-10 Condition: I509||Heart failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dapagliflozin |
Participants in the intervention group will receive tablet dapagliflozin 10 mg orally once daily, starting within 24 hours of hospital admission, in addition to standardized care for 30 days. |
| Comparator Agent |
standard of care |
Participants in the control group will only receive standardized care, including loop diuretics, vasodilators, and GDMT after clinical stabilization, including ACEi/ARNI, beta-blockers, and MRAs. The dosage of diuretics and vasodilators will be determined based on clinical parameters. Hypoxic patients (oxygen saturation of less than 92%) will receive oxygen therapy through nasal prongs, face masks, venturi masks, and non-rebreather masks, which will be decided based on clinical parameters. The patient will be put on a ventilator or NIV if necessary. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
patients present to the medical emergency with acute heart failure NYHA III or IV, with a systolic blood pressure above 100 mmHg, with the following
Any one of the following clinical features- elevated JVP, ascites, pedal edema, crackles on auscultation, weight gain of more than 2 kgs over the last 3 days
Chest x-ray is suggestive of volume overload, that is, venous cephalization, Kerley B lines, bat-wing patterns, and pleural effusion
BNP more than 100 ng per lt or NT-pro-BNP more than 300 ng per lt
|
|
| ExclusionCriteria |
| Details |
Type 1 diabetes mellitus
Cardiogenic shock (MAP less than 60 mmHg or requiring vasopressor support to maintain MAP or lactate more than 4)
History of acute coronary syndrome in the past 30 days (ST elevation or depression more than 1 mm in more than 2 consecutive leads with Trop-I more than 40 ng per L)
End-stage renal disease with eGFR of less than 30 ml/min/1.73m2
Chronic liver disease
Chronic lung disease (COPD and ILD)
COVID-19 Positive patients
Non-cardiogenic dyspnea
Patient taking any SGLT2i as an outpatient chronic therapy
Pregnant or lactating woman
Heart failure due to chemotherapy or radiation toxicity
The patient had any cardiac surgery or intracardiac implantation or pacemakers, or ventricular assist devices.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effectiveness of dapagliflozin as a treatment for acute heart failure in reducing the combined primary endpoint: a composite of 30-day all-cause mortality and 30-day re-admission in patients presenting to the medical emergency |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of dapagliflozin in reducing the length of hospital stay.
To evaluate the effect of dapagliflozin on the symptomatic relief of acute heart failure, particularly focusing on the severity of dyspnea as assessed by the dyspnea visual analogue scale between day 1 and day 5.
To assess the impact of dapagliflozin on percent changes in pro-BNP levels at admission and on the fifth day or at discharge.
To evaluate the diuretic efficiency of dapagliflozin expressed in terms of the requirement of the cumulative dose of loop diuretics.
To assess the adverse effects of dapagliflozin over standard treatment in acute heart failure
|
Day 5 or at discharge |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [souravpaul7598@gmail.com].
- For how long will this data be available start date provided 01-12-2026 and end date provided 01-12-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is an open-label, parallel-group, randomized controlled trial conducted at PGIMER, Chandigarh, designed to evaluate the efficacy of dapagliflozin in reducing all-cause mortality and 30-day hospital readmissions in patients with acute heart failure. Adult patients presenting to the medical emergency with acute heart failure, evidenced by dyspnea at rest or minimal exertion and clinical signs of volume overload, will be screened. Key exclusion criteria include pregnancy/lactation, type 1 diabetes mellitus, cardiogenic shock, end-stage renal disease, chronic liver or lung disease (COPD/ILD), COVID-19, and prior SGLT2 inhibitor use. Participants will be randomized to receive either dapagliflozin 10 mg orally once daily within 24 hours of admission plus standard care, or standard care alone, which includes loop diuretics, vasodilators, and GDMT (ACEi/ARNI, beta-blockers, MRAs) post-stabilization. Outcomes include in-hospital symptomatic improvement, fluid status, diuretic requirements, cardiac biomarkers, and drug safety profiles. Patients will be followed for 30 days post-discharge to assess clinical status and hospital readmissions |