| CTRI Number |
CTRI/2025/02/080087 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improvement in Hearts Condition with different doses of novel Dapagliflozin in patient of Heart Failure and Comparison of strength and side effects in Between Different Doses of Dapagliflozin |
|
Scientific Title of Study
|
Safety and Efficacy Comparison of 5 mg and 10 mg of Dapagliflozin in Patients with Heart Failure with Reduced Ejection Fraction |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ala Ram |
| Designation |
DM Cardiology Resident |
| Affiliation |
Dr. S. N. Medical college jodhpur |
| Address |
Room No. 11, cardiology opd, MDM Hospital, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9549675742 |
| Fax |
|
| Email |
alaramsuthar42@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Mathur |
| Designation |
Professor and Head Department of Cardiology |
| Affiliation |
Dr. S. N. Medical college jodhpur |
| Address |
Cardiology HOD office, Cardiology block, MDM Hospital, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9462200997 |
| Fax |
|
| Email |
drrohitmathur@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ala Ram |
| Designation |
DM Cardiology Resident |
| Affiliation |
Dr. S. N. Medical college jodhpur |
| Address |
Room No. 11, cardiology opd, MDM Hospital, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9549675742 |
| Fax |
|
| Email |
alaramsuthar42@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. S. N. Medical College, Jodhpur
Residency road, Sector - D, shastri nagar, Jodhpur, Rajasthan, India.
Pin 342003 |
|
|
Primary Sponsor
|
| Name |
Dr S N Medical College Jodhpur |
| Address |
Dr. S. N. Medical College, Jodhpur Residency road, Sector - D, shastri nagar, Jodhpur, Rajasthan, India. Pin 342003 |
| 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 Ala Ram |
Dr. S. N. Medical college, Jodhpur |
room no 11, cardiology opd, Cardiology block, MDM hospital, jodhpur 342003
Jodhpur
RAJASTHAN |
9549675742
alaramsuthar42@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, dr. S. N. Medical College, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I504||Combined systolic (congestive) anddiastolic (congestive) heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
10mg dapagliflozin, orally, once a day |
10mg dapagliflozin, orally, once a day, will be given to comparator group |
| Intervention |
5mg dapagliflozin, orally, once a day |
5mg of dapagliflozin, orally, once a day, after lunch, will be given to patient of heart failure with reduced ejection fraction and followed up and compared to comparator. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Eligibility requirements included an age of more than 18 years, an ejection fraction of 40% or less, and New York Heart Association (NYHA) class II, III, or IV symptoms. |
|
| ExclusionCriteria |
| Details |
unacceptable side effects with dapagliflozin in past, recent treatment with dapagliflozin, Hypotension, eGFR below 30ml/minute |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare change in NTproBNP from baseline
2.To compare change in Echocardiographic changes (ejection fraction, left ventricular end diastolic diameter, left ventricular diastolic dysfunction E/E’) from baseline
3.Incidence of adverse events |
1. To compare change in NTproBNP from baseline at the end of 1 month, 3 month and 6 month.
2.To compare change in Echocardiographic changes (ejection fraction, left ventricular end diastolic diameter, left ventricular diastolic dysfunction E/E’) from baseline at the end of 1 month, 3 month and 6 month.
3.Incidence of adverse events during 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes were the total number of hospitalizations for heart failure (including repeat admissions) & cardiovascular deaths |
At the end of 6th month. |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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 3 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
this Randomized, open labeled control trial entitled “Safety and Efficacy Comparison of 5 mg and 10 mg of Dapagliflozin in Patients with Heart Failure with Reduced Ejection Fraction” will be conducted at the department of cardiology, MDM hospital attached to Dr S.N. Medical College, Jodhpur. after randomization and applying of inclusion and exclusion criteria patients will enter into this trial. initial assessment with routine investigation and NTproBNP, 2D echocardiography will be done. patient will be followed at 1month, 3month and 6month. than we will apply statistical analysis on collected data and make inference. |