| 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
|
|
|
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
|
|
|
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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