| CTRI Number |
CTRI/2025/03/082263 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFICACY OF SODIUM GLUCOSE CO TRANSPORTER II DAPAGLIFLOZIN IN HEART FAILURE PATIENTS |
|
Scientific Title of Study
|
EFFICACY OF DAPGLIFLOZIN IN PATIENTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION - A RANDOMIZED CONTROLLED TRIAL STUDY |
| 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 Saurav P Singhvi |
| Designation |
Post Graduate |
| Affiliation |
department of general medicine srm medical college hospital and research centre |
| Address |
room number 5
department of general medicine
srm medical college hospital and research centre
mahatma gandhi road
kattankulathur
kancheepuram
Kancheepuram
TAMIL NADU
603211
India |
| Phone |
7010901236 |
| Fax |
27455106 |
| Email |
sp7468@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. C Nirmala devi |
| Designation |
associate professor department of general medicine |
| Affiliation |
srm medical college hospital and research centre |
| Address |
room number 5
department of general medicine
srm medical college hospital and research center
mahatma gandhi road , potheri ,kattankulathur
Kancheepuram
TAMIL NADU
603211
India |
| Phone |
04447432855 |
| Fax |
27455106 |
| Email |
nirmalac@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurav P Singhvi |
| Designation |
post graduate |
| Affiliation |
srm medical college hospital and research centre |
| Address |
room number 5
department of general medicine
srm medical college hospital and research centre
mahatma gandhi road
potheri
kattankulathur
kancheepuram
Kancheepuram
TAMIL NADU
603211
India |
| Phone |
7010901236 |
| Fax |
27455106 |
| Email |
sp7468@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM medical college hospital and research centre |
|
|
Primary Sponsor
|
| Name |
srm university |
| Address |
room number 5
department of general medicine
srm medical collge hospital and research centre
mahatma gandhi road
potheri
kattankulathur
kancheepuram
tamil nadu 603211 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Saurav P Singhvi |
srm medical college hospital and research centre |
room number 5
department of general medicine
srm medical college hospital and research centre
mahatma gandhi road
potheri
katankulathur
Kancheepuram
TAMIL NADU |
7010901236
27455106
sp7468@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee - students |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
TABLET ANTIHYPERTENSIVES
TABLETS ORAL HYPOGLYCEMIC AND BACKGROUND MEDICAL THERAPY OF PATIENTS IS CONTINUED APART FROM SODIUM GLUCOSE CO TRANSPORTER II DAPAGLIFLOZIN
|
TABLET ORAL HYPOGLYCEMIC AGENTS
TABLET ANTIHYPERTENSIVES AND OTHER MEDICAL THERAPY OF PATIENTS ARE BEING CONTINUED EXCEPT SODIM GLUCOSE CO TRANSPORTER II DAPAGLIFLOZION |
| Intervention |
TABLET.DAPAGLIFLOZIN 10 MG OD |
TABLET DAPAGLIFLOZIN 10 MG ONCE A DAY IS GIVEN TO PATIENTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION FOR THREE MONTHS AND FOLLOWED UP REGUARLY OVER THE PWERIOD OF THREE MONTHS .AT THE THIRD MONTH AN ECHOCARDIOGRAPHY TEST IS PERFORMED AND IMPROVEMENT OF EJECTION FRACTION AND CLINICAL IMPROVEMENT OF PATIENT IS LOOKED FOR EFFICACY OF INTERVENTION BY DAPAGLIFLOZIN |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
MALE AND FEMALE
CONSENTING TO PARTICIPATE IN THE STUDY
LEFT VENTICULAR EJECTION FRACTION MORE THAN 50 %
PATIENTS WITH INCRASED N TERMINAL PRO BRAIN NATRIURETIC PEPTIDE MORE THAN 300 PG
KNOWN TYPE II DIABETES MILLETUS PATIENT NOT ON SODIUM GLUCOSE CO TRANSPORTER II THERAPY
|
|
| ExclusionCriteria |
| Details |
PATIENT NOT CONSENTING TO PARTICIPATE IN STUDY
CHRONIC KIDNEY DISEASE WITH ESTIMATED GLOMERULAR FILTRATION RATE OF LESS THAN 20 ML PER MINUTE
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
CHRONIC LUNG DISEASE
PATIENTS WITH MYOCARDIAL INFARCTION
CORONARY ARTERY BY PASS GRAFT
CARDIOMYOPATHIES
VALVULAR HEART DISEASE
CURRENT OR PRIOR USE OF SODIUM GLUCOSE CO TRANSPORETER II INHIBITORS
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IMPROVEMENT OF EJECTION FRACTION OF PATIENTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION PATIENT INITIATED ON TABLET DAPAGLIFLOZIN 10MG ONCE A DAY AND REVIEWED AFTER THREE MONTHS OF INITIATION OF THERAPY AND CLINICAL IMPROVEMENT IN PATIENTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION |
Follow up of patients with heart failure with preserved ejection fraction with echocardiography on initial zero visit and follow up at Three months and n terminal pro brain natriuretic peptide at initial visit at o day and followed up for improvement at second visit at three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CLINICAL IMPROVEMENT IN KCCQ SCORE |
2 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
23/03/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
THIS STUDY WAS CONDUCTED IN PATIENTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION WHICH WAS IDENTIFIED ACCORDING TO THE INCLUSION AND EXCLUSION CRITERIAS. PATIENTS WERE INITIATED ON SODIUM GLUCOSE CO TRANSPORTER II - TABLET DAPAGLIFLOZIN 10MG ONCE A DAY ON INITIAL VISIT O AND FOLLOWED UP WITH PATIENT ON TABLET DAPAGLIFLOZIN 10MG FOR A PERIOD OF THREE MONTHS AND FOLLOWED UP AT THREE MONTHS FOR REPEAT 2 DIMENSIONAL ECHOCARDIOGRAPHY AND N TERMINAL BRAIN NATREURETIC PEPTIDE WITH ASSESMENT OF CLINICAL IMPROVEMENT OF THE PATIENT ON FOLLOW UP TO DETERMINE THE EFFICACY OF DAPAGLIFLOZIN OF PATIENTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION |