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CTRI Number  CTRI/2026/01/101882 [Registered on: 23/01/2026] Trial Registered Prospectively
Last Modified On: 22/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Study at how a diabetes medicine called dapagliflozin can help people who have both heart failure and diabetes with help of 2Decho 
Scientific Title of Study   The effect of dapaglifozin on cardiac remodelling and cardiac biomarkers in patients of heart failure and diabetes mellitus An observational 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  KRaaga Meghana 
Designation  Junior resident  
Affiliation  Dr.D Y Patil medical college,NAVI Mumbai  
Address  Department of general Medicine,Dr.D Y Patil Medical college,Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9177033678  
Fax    
Email  meghana3456@ gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dinesh Patil  
Designation  Professor  
Affiliation  Dr D Y Patil medical college  
Address  Department of general medicine,Dr.D Y Patil, medical college,Navi mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9177033678  
Fax    
Email  drdjpatil@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dinesh Patil  
Designation  Professor  
Affiliation  Dr D Y Patil medical college  
Address  Department of general medicine,Dr.D Y Patil, medical college,Navi mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9177033678  
Fax    
Email  drdjpatil@hotmail.com  
 
Source of Monetary or Material Support  
Dr.D Y Patil medical college and hospital,Nerul,NAVI Mumbai,Maharashtra,India,400706 
 
Primary Sponsor  
Name  DrKRaaga Meghana 
Address  Department of general medicine,Dr.D Y Patil medical college,navi mumbai,400706 
Type of Sponsor  Other [Primary investigator ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raaga Meghana   Dr.DY Patil hospital,NAVI Mumbai  OPD-1(General medicine),Female medicine ward,Male medicine ward,Intensive care unit,cardiology opd,DY Patil Medical College,Navi Mumbai ,Thane,Maharashtra
Thane
MAHARASHTRA 		 9177033678

meghana3456@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee(IEC) for biomedical and health research,Dr D Y Patil Medical college,Navi Mumbai   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I509||Heart failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with both heart failure and type 2 diabetes mellitus
2. Patients aged 18 years or above
3. Patients willing to provide informed consent
4. Patients able to comply with follow-up visits
5. For Dapa (+) group: Patients already on dapagliflozin 10 mg once daily as part of their treatment regimen
6. For Dapa (-) group: Patients not receiving any SGLT2 inhibitor
 
 
ExclusionCriteria 
Details  1. Patients with type 1 diabetes mellitus
2. Patients with severe renal impairment (eGFR less than 30mL per min)
3. Patients with documented hypersensitivity or contraindications to dapagliflozin
4. Patients with acute coronary syndrome within the past 3 months
5. Pregnant or lactating women
6. Patients with malignancy or life-threatening conditions
7. Patients unwilling to provide informed consent
8. Patients unable to comply with follow-up requirements 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine association between dapagliflozin, cardiac bio markers and cardiac remodeling in patients with heart failure and type 2 diabetes mellitus.  6months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the risk of developing heart failure in diabetic patients.  1 year 
 
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   N/A 
Date of First Enrollment (India)   05/02/2026 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [meghana3456@gmail.com].

  6. For how long will this data be available start date provided 01-11-2026 and end date provided 01-11-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
1. To determine the association between dapagliflozin, cardiac biomarkers, and cardiac remodeling in patients with heart failure and type 2 diabetes mellitus.
2. To evaluate the risk of developing heart failure in diabetic patients.
3. To explore other potential findings related to dapagliflozin’s impact on cardiac health in patients with heart failure and type 2 diabetes mellitus.
 
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