| CTRI Number |
CTRI/2025/08/092575 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two medicines, Dapagliflozin and Empagliflozin, in patients with heart failure to see which works better and is safer. |
|
Scientific Title of Study
|
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 |
| 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 Geerthana Thamizhvanan |
| Designation |
Postgraduate |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Room no 6, Department of Pharmacology, 13-A, Pondy-Villupuram Main Road, Ariyur, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9751458352 |
| Fax |
|
| Email |
thamizhvanangeerthana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayasheela J |
| Designation |
Associate Professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Room no 6, Department of Pharmacology, 13-A, Pondy-Villupuram Main Road, Ariyur, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9003679174 |
| Fax |
|
| Email |
saisashe05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geerthana Thamizhvanan |
| Designation |
Postgraduate |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Room no 6, Department of Pharmacology, 13-A, Pondy-Villupuram Main Road, Ariyur, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9003679174 |
| Fax |
|
| Email |
thamizhvanangeerthana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self-funded Post Graduate thesis
Dr Geerthana Thamizhvanan
Sri Venkateshwaraa Medical College Hospital and Research Centre
Room no 6, Department of Pharmacology, 13-A, Pondy-Villupuram Main Road, Ariyur, Puducherry. |
|
|
Primary Sponsor
|
| Name |
Dr Geerthana Thamizhvanan |
| Address |
13-A, Pondy-Villupuram Main Road, Ariyur, Puducherry |
| Type of Sponsor |
Other [Self-funded Post Graduate thesis] |
|
|
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 Geerthana Thamizhvanan |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
Room no 6 Department of Pharmacology and room no 14 Department of Cardiology, 13-A, Pondy-Villupuram Main Road, Ariyur, Puducherry
Pondicherry
PONDICHERRY |
09751458352
thamizhvanangeerthana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC- Sri Venkateshwaraa Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I509||Heart failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dapagliflozin |
Dapagliflozin 10mg orally once daily, administered in addition to standard heart failure therapy for 1 year |
| Intervention |
Empagliflozin |
Empagliflozin 10mg orally once daily, administered in addition to standard heart failure therapy for 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
Patients with type 1 diabetes mellitus.
Patients with HbA1c more than 10 percent.
Severe renal impairment (eGFR less than 30mL per min per 1.73m²).
History of diabetic ketoacidosis.
History of allergic reactions to SGLT2 inhibitors.
History of active genitourinary tract infection.
Pregnancy or Lactation.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
At baseline, 6 months and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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. |
At baseline, 6 months and 12 months. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="6"
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
|
Written consent forms will be obtained from the study participants. Patients diagnosed with heart failure will be divided into two groups by lottery method. The sequence will be generated in advance ensuring equal allocation to both groups in a 1:1 ratio. Group 1- will be given Dapagliflozin 10mg OD for 1 year. Group 2- will be given Empagliflozin 10mg OD 1 year. Standard heart failure therapy continued for both groups. Demographic profile, vital signs, laboratory investigations including serum electrolytes, blood glucose levels (HbA1C), Renal function tests, urine routine analysis, Cardiac function indices including NYHA functional class, transthoracic echocardiographic indicators containing LVEF, left ventricular end-diastolic diameter (LVEDD) and LA volume index will be recorded before the treatment, after 6 months and 12 months of therapy. The hospitalization rates will be estimated between both groups. The changes in echo parameters, improvement in functional class (NYHA class), changes in renal parameters, serum electrolytes and urine routine analysis will be measured. |