| CTRI Number |
CTRI/2023/12/060807 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
26/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the benefits of the drug named Dapagliflozin in the Treatment of Diastolic Heart failure |
|
Scientific Title of Study
|
EFFICACY OF SGLT2 INHIBITORS ON LV DIASTOLIC DYSFUNCTION AND PREVENTION OF NEW ONSET ATRIAL FIBRILLATION IN DIASTOLIC HEART FAILURE PATIENTS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSubbiah |
| Designation |
Post graduate in General medicine |
| Affiliation |
Saveetha Medical college and Hospital |
| Address |
General medicine and Cardiology OPD, Ground floor, Saveetha Medical college and hospital, Thandalam, Chennai
Chennai
TAMIL NADU
600069
India |
| Phone |
9994440808 |
| Fax |
|
| Email |
snsubbiah7177@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGunasekaran |
| Designation |
Professor, General medicine |
| Affiliation |
Saveetha Medical college and Hospital |
| Address |
General medicine and Cardiology OPD, Ground floor, Saveetha Medical college and hospital, Thandalam, Chennai
Chennai
TAMIL NADU
600069
India |
| Phone |
9884398420 |
| Fax |
|
| Email |
drguna59@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSubbiah |
| Designation |
Post graduate in General medicine |
| Affiliation |
Saveetha Medical college and Hospital |
| Address |
General medicine and Cardiology OPD, Ground floor, Saveetha Medical college and hospital, Thandalam, Chennai
TAMIL NADU
600069
India |
| Phone |
9994440808 |
| Fax |
|
| Email |
snsubbiah7177@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical college and Hospital, Kuthambakkam, Thandalam, Kanchipuram district, Chennai |
|
|
Primary Sponsor
|
| Name |
DrSubbiah |
| Address |
Saveetha Medical college and Hospital Thandalam chennai |
| Type of Sponsor |
Other [Others [self]] |
|
|
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 |
| DrSubbiah |
Saveetha Medical college and Hospital |
General Medicine OPD and Cardiology OPD, ground floor, Saveetha medical college and hospital, Thandalam, Chennai
Chennai
TAMIL NADU |
9994440808
snsubbiah7177@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical and Hospital Institutional Ethics Committee ( SMCH- IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DAPAGLIFLOZIN |
Dapagliflozin administered orally 10 mg once daily for a period of 6 months and LV diastolic parameters are measured at baseline and at the end of 6 months |
| Comparator Agent |
TELMISARTAN |
Telmisartan administered orally 40 mg once daily for a period of 6 months and LV diastolic parameters are measured at baseline and at the end of 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged more than 18 years of age diagnosed with Diastolic Heart failure are included
Diastolic Heart failure patients under treatment with either Dapagliflozin 10 mg or Telmisartan 40mg
LVEF> 45% documented by echocardiography
|
|
| ExclusionCriteria |
| Details |
Patients with systolic Heart failure with EF< 45%
Uncontrolled Hypertension with systolic
BP>140 mmhg or Diastolic Bp>90 mmhgare excluded
Uncontrolled Diabetis mellitus with FBS>125 mg/dl or PPBS>200 mg/dl are excluded
Patients who need step up treatment in Baseline Regimen dosage for Hypertension or Diabetes mellitus during course of study are excluded
Patients who develop acute exacerbation or symptoms of congestive HF or those who need treatment with Diuretics during course of study are excluded
Presence of cardiomyopathy due to infiltrative disorders- amyloidosis, sarcoidosis are excluded
Dyspnea due to primary lung disorder |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measuring improvemnt in LV diastolic function with 2D Echocardiography |
Baseline, and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| First occurrence of decline in renal function from baseline |
Baseline, 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
16/01/2024 |
| 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
|
Sodium glucose co-transporter 2 (SGLT2) Inhibitors has proven to reduce the combined risk of hospitalization for heart failure or cardiovascular death among patients with diastolic heart failure and aids in Decongestion- thus improving Diastolic function and helps in improving Exercise capacity. SGLT2 inhibitors (SGLT2i) have demonstrated robust benefits in terms of the prevention of heart failure (HF) and the reduction in cardiovascular mortality. In this study, we are going to investigate the efficacy of SGLT2 Inhibitors on left ventricular diastolic parameters by comparing 2 groups- one group taking Dapagliflozin and other group taking Telmisartan and followed up for 6 months. Echo LV diastolic parameters such as a mitral peak E-wave velocity to early mitral or septal annular tissue Doppler velocity ratio (E/e′) are measured at end of 6 months
|