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CTRI Number  CTRI/2024/07/071466 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 02/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective study 
Study Design  Other 
Public Title of Study   SGLT2i, ARNi And Diuretic Use In Patients With Heart Failure  
Scientific Title of Study   SGLT2i, ARNi And Diuretic Use In Patients With Heart Failure With Preserved And 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  Mohammad Saabiq Samad 
Designation  M.Pharm student 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte, Mangalore, Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7204882750  
Fax    
Email  saabiq1234567@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Roopa Satyanarayan Basutkar 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte, Mangalore, Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Roopa Satyanarayan Basutkar 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte, Mangalore, Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Paneer, Deralakatte, Mangaluru, Karnataka - 575018 
 
Primary Sponsor  
Name  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Paneer, Deralakatte, Mangaluru, Karnataka - 575018 
Type of Sponsor  Private hospital/clinic 
 
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 
Mohammad Saabiq Samad  Justice K S Hegde Charitable Hospital  Department of Cardiology, Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA 
7204882750

saabiq1234567@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical Sciences Ethics Committee (NGSMIPS-IEC)  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 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Age equal to or greater than 18 years old
EF lesser than or equal to 40 percent for HFrEF and EF greater than or equal to 50 percent for HFpEF with or without Type-2 diabetes mellitus
Initiation of SGLT2i
Prescribed a loop diuretic and sacubitril valsartan prior to the initiation of SGLT2i 
 
ExclusionCriteria 
Details  Estimated glomerular filtration rate less than 20 mL per min per 1.73 meter square or undergoing dialysis
Chronic heart failure persisting for a minimum of 6 months, with an ejection fraction below 25 percent at the commencement of SGLT2 inhibitor therapy
Discontinuation of SGLT2 inhibitors
Inadequate data in the patient medical records
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in loop diuretic and sacubitril/valsartan dose  Baseline and after dose alteration of loop diuretics, ARNi and SGLT2i 
 
Secondary Outcome  
Outcome  TimePoints 
Dose change in other diuretic medications, Clinical parameters: RFT, Hematocrit (%), NYHA classification, electrolytes levels, lipid levels, blood sugar levels, ADRs to medications during the study period, Discontinuation of SGLT2 inhibitors because of volume depletion, Discontinuation of SGLT2 inhibitors due to other adverse reactions  Baseline and after dose alteration of loop diuretics, ARNi and SGLT2i 
 
Target Sample Size   Total Sample Size="103"
Sample Size from India="103" 
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)   31/07/2024 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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  
SGLT2 inhibitors are a class of medications approved for use in type 2 diabetes to treat hyperglycemia. Patients with HFrEF typically receive therapy with loop diuretics, considered the standard kind of diuretics. SGLT2i have demonstrated the capability to reduce the likelihood of hospitalisation for heart failure (HF), independent of diabetes status. It has also presented a reduced pace of decrease in the estimated glomerular filtration rate (GFR). These findings are backed by many trials. Renal assessments from certain clinical trials offer further confirmation that SGLT2 inhibitors possess kidney-protective effects, leading to a notably decreased risk of advancing to macroalbuminuria or experiencing clinically significant renal outcomes, such as doubling of serum creatinine levels and the need for renal replacement therapy. SGLT2 inhibitors possess the potential to exacerbate the diuretic impact of traditional treatments, which might result in a decrease in volume. On the contrary, considering SGLT2 inhibitors exert a minimal diuretic effect, they are unlikely to have an enormous effect on the strong action of loop diuretics. The effects of SGLT2 inhibitor administration to HFrEF who were already on sacubitril/valsartan were investigated in a different study. According to this investigation, the combination of the aforementioned drugs could assist patients with HFrEF have even fewer instances of morbidity and death. 
Numerous investigations have exhibited the possible therapeutic effectiveness of SGLT2i in the management of cardiovascular events via diverse methods. However, the impact of SGLT2i on the dosage of loop diuretics and sacubitril/valsartan while treating heart failure patients who are on background diuretics and sacubitril/valsartan has not been well studied. Therefore, further research must be done to fully comprehend this process. This study intends to investigate the impact of SGLT2i on loop diuretic and sacubitril/valsartan dose in heart failure patients already on diuretics and sacubitril/valsartan and scrutinize the shift in loop diuretic dose and sacubitril/valsartan over a certain period.


 
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