| CTRI Number |
CTRI/2025/01/079180 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To study the efficacy of dapagliflozin (sodium glucose co transporter-2 inhibitor) in heart failure with reduced ejection fraction in tertiary care hospital in central india |
|
Scientific Title of Study
|
Efficacy of Dapagliflozin in heart failure with reduced ejection fraction: 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 |
Dr Meghna Bordoloi |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi (meghe) |
| Address |
Department of Medicine, Jawaharlal Nehru Medical College, Sawangi (meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9678861561 |
| Fax |
|
| Email |
meg12shelly@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Bawankule |
| Designation |
Professor of Medicine |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi (meghe) |
| Address |
Room no 303
Department of Medicine Jawaharlal Nehru Medical College, Sawangi (meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9678861561 |
| Fax |
|
| Email |
drshilpagaidhane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meghna Bordoloi |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi (meghe) |
| Address |
Jawaharlal Nehru Medical College, Sawangi (meghe)
Room T16, Third floor, Shalinta PG Girls Hostel
Jawaharlal Nehru Medical College, Sawangi (meghe)
Room T16, Third floor, Shalinta PG Girls Hostel
Wardha
MAHARASHTRA
442001
India |
| Phone |
9678861561 |
| Fax |
|
| Email |
meg12shelly@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, sawangi (meghe)
Wardha
442001
Maharashtra
India
|
|
|
Primary Sponsor
|
| Name |
Dr Meghna Bordoloi |
| Address |
Jawaharlal Nehru Medical college, Sawangi (meghe)
Wardha
442001
Maharashtra
India |
| Type of Sponsor |
Other [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 |
| Dr Meghna Bordoloi |
Acharya Vinoba Bhave Rural Hospital |
Department of medicine,
AVBRH
Jawaharlal Nehru Medical college, Sawangi (meghe)
Wardha
442001
Maharashtra
India
Wardha
MAHARASHTRA |
9678861561
meg12shelly@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Sawangi (meghe), Wardha-442 107, Maharashtra, India |
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 |
| Intervention |
Tab Dapagliflozin 10 MG OD for 12 months |
Patient of heart failure with reduced ejection fraction who are enrolled for the study after obtaining informed consent will be observed for use of Tab Dapa 10MG once daily for 12 months.
this will be an observational study where all patients who satisfy Inclusion criteria will be observed for 12 monts. Group 1 will recieve DAPA 10 mg od and other group 2 (comparator) who are not on dapa due to any reasons. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of both genders aged 18 years or older.
2. Diagnosis of ischemic heart disease.
3. Fulfillment of the Framingham criteria for heart failure.
4. Left ventricular ejection fraction (LVEF) documented to be ≤ 45% within the last 1-2 months.
5. Willingness to provide written informed consent.
6. Ability and willingness to adhere to SGLT-2 inhibitor therapy.
|
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Improvements in cardiometabolic parameters, NYHA class, and echocardiographic measures over the 12-month follow-up period. Furthermore, we expect to observe a reduction in cardiovascular death and recurrent hospitalization rates among patients receiving dapagliflozin therapy. Safety analyses will provide insights into the tolerability and adverse event profile of dapagliflozin in this patient population. |
The said outcome will be measured at baseline, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvements in KFT and LFT,
Decrease in HBA1C levels,
Signs of dehydration
|
baseline, 6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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 4 |
|
Date of First Enrollment (India)
|
02/02/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
- Potential participants meeting the eligibility criteria will be identified through screening of patients attending the medicine outpatient department (OPD) and discharged cases from the Medical Intensive Care Unit (MICU) at Acharya Vinobha Bhave Rural Hospital, Sawangi, Meghe. Screening will involve a review of medical records, including recent echocardiography reports, to confirm left ventricular ejection fraction (LVEF) ≤ 45%.
- Upon obtaining informed consent, enrolled patients will undergo baseline assessments, including socio-demographic data collection, anthropometric measurements, evaluation of cardiometabolic risk factors, determination of NYHA class, and baseline 2D echocardiography to measure LVEF.
- Enrolled patients will be initiated on dapagliflozin 10 mg once daily.
- Patients will be scheduled for followup visits at 6-month intervals (i.e., at six months, and twelve months post-baseline). At each followup visit, assessments will be conducted to evaluate the impact of dapagliflozin treatment on various parameters, including cardiometabolic risk factors, NYHA class, echocardiographic measures, and incidence of adverse events.
- The study will be considered complete after the final followup visit at twelve months post-baseline. Data collected will be analyzed to evaluate the efficacy and safety of dapagliflozin in patients with heart failure with reduced ejection fraction.
|