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CTRI Number  CTRI/2025/10/096013 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On: 13/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to compare the effects of SGLT2 inhibitor medicine alone and in combination with diuretics on heart and kidney health in diabetic and non-diabetic patients with heart failure. 
Scientific Title of Study   Comparison of SGLT2 inhibitor monotherapy and combination therapy with Loop Diuretics in Heart Failure among diabetic and non-diabetic individuals 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Disha Shetty 
Designation  Student 
Affiliation  Manipal College of Pharmaceutical Sciences 
Address  Pharmacy Practice Department, Manipal College of Pharmaceutical Sciences, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9964020904  
Fax    
Email  disha1.mcopsmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. Prasanna Kumar 
Designation  Assistant Professor-SG 
Affiliation  Manipal College of Pharmaceutical Sciences 
Address  Pharmacy Practice Department, Manipal College of Pharmaceutical Sciences, Manipal, Udupi, Karnataka


KARNATAKA
576104
India 
Phone  9886725129  
Fax    
Email  prasanna.shetty@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Disha Shetty 
Designation  Student 
Affiliation  Manipal College of Pharmaceutical Sciences 
Address  Pharmacy Practice Department, Manipal College of Pharmaceutical Sciences, Manipal, Udupi, Karnataka


KARNATAKA
576104
India 
Phone  9964020904  
Fax    
Email  disha1.mcopsmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospital Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104  
 
Primary Sponsor  
Name  Kasturba Medical College and Hospital 
Address  Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104 
Type of Sponsor  Private medical college 
 
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 Ganesh Paramasivam  Katurba Medical College and Hospital  Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 		 9914204224

ganesh.p@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2(Student Research)  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adults aged eighteen years and above

Diagnosed with heart failure either reduced or preserved ejection fraction (ICD code I50.0 to I50.9)

Prescribed either SGLT2 inhibitor monotherapy or combination therapy with SGLT2 inhibitor and loop diuretic

Includes both diabetic and non diabetic individuals (ICD code E11.0 to E11.9)

Availability of complete clinical records including medication history, laboratory investigations and outcome data

Patients managed in either inpatient or outpatient settings 
 
ExclusionCriteria 
Details  Pregnant women and lactating women

Patients with incomplete or missing data

Patients with end stage renal disease or those on dialysis

Patients receiving SGLT2 inhibitors exclusively for glycemic control without a documented diagnosis of heart failure

Patients with chronic illnesses such as malignancy, human immunodeficiency virus infection, nutritional deficiency disorders or gestational diabetes 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the impact on clinical outcomes, renal function, and cardiac biomarkers between SGLT2
inhibitor monotherapy and combination therapy with loop diuretics in heart failure patients. 		 At Baseline, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline, 52 weeks after baseline, 104 weeks after baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To perform subgroup analyses to determine if the observed differences in clinical outcomes, renal
function, & cardiac biomarkers vary between diabetic & non-diabetic heart failure patients receiving
SGLT2 inhibitor monotherapy versus combination therapy with loop diuretics. 		 At Baseline, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline, 52 weeks after baseline, 104 weeks after baseline 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   25/10/2025 
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="2"
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-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [disha1.mcopsmpl2024@learner.manipal.edu].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This prospective longitudinal study will evaluate and compare the clinical outcomes, renal function, and cardiac biomarker changes in patients with heart failure receiving SGLT2 inhibitor monotherapy and those receiving a combination of SGLT2 inhibitors with loop diuretics. The study will include both diabetic and non-diabetic individuals diagnosed with heart failure and will monitor parameters such as BNP or NT-pro BNP levels, electrolyte balance, urine output and NYHA functional class over the study period. The findings are expected to provide insights into optimizing therapeutic strategies and ensuring safe, effective and evidence-based management of heart failure. 
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