| CTRI Number |
CTRI/2025/09/095418 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
An Observational Study To See How Drugs Called SGLT2 Inhibitors Work in Men and Women with Weak Heart Function |
|
Scientific Title of Study
|
Gender Specific Effectiveness Of SGLT2 Inhibitors In Heart Failure With Reduced Ejection Fraction- A Prospective 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. Aarthikaa R |
| Designation |
Senior Resident |
| Affiliation |
PGIMER |
| Address |
4019, FOURTH FLOOR, DEPARTMENT OF PHARMACOLOGY, RESEARCH BLOCK B, PGIMER, SECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09360461215 |
| Fax |
|
| Email |
aarthikaadr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Samir Malhotra |
| Designation |
Professor and Head |
| Affiliation |
PGIMER |
| Address |
4001,FOURTH FLOOR, DEPARTMENT OF PHARMACOLOGY, RESEARCH BLOCK B, PGIMER, SECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417016343 |
| Fax |
|
| Email |
smal.pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Aarthikaa R |
| Designation |
Senior Resident |
| Affiliation |
PGIMER |
| Address |
4019, FOURTH FLOOR, DEPARTMENT OF PHARMACOLOGY, RESEARCH BLOCK B, PGIMER, SECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09360461215 |
| Fax |
|
| Email |
aarthikaadr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Advanced Cardiac Center OPD, Cardiology department, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Aarthikaa R |
PGIMER |
Advanced Cardiac Center OPD, Department of Cardiology, PGIMER
Chandigarh
CHANDIGARH |
09360461215
aarthikaadr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(PGIMER) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I502||Systolic (congestive) heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis of HFrEF as per ACC/ AHA 2022 with NYHA class II-III heart failure
symptoms.
2. HFrEF patients newly initiated on SGLT-2 inhibitor.
3. Patients should receive background standard of care for HFrEF and be treated according
to locally recognized guidelines with both drugs and devices, as appropriate.
4. Patient willing to provide written informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Any kind of severe comorbities, which delimits the patient from giving consent and
participation in the study.
2. Any previous history of allergy with SGLT2 inhibitor.
3. Type 1 diabetes mellitus (T1DM).
4. Symptomatic hypotension or systolic BP less than 95 mmHg on 2 consecutive measurements.
5. Severe (eGFR less than 30mL/min/1.73 m2 by CKD-EPI), unstable or rapidly progressing renal
disease at the time of screening.
6. Pregnant, Lactating mother and women of child-bearing potential (who are not willing
to use a medically accepted method of contraception). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare changes in patient-reported outcomes using Kansas City Cardiomyopathy
Questionnaire (KCCQ) between genders. |
0,3,6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the efficacy SGLT2 inhibitors in reducing HF-related hospitalizations and 3 point
MACE (Cardiovascular death, Non-fatal MI, and Non-fatal stroke) between male and
female patients.
2. To assess gender-specific changes from baseline in key clinical, biochemical, and
functional parameters.
3. To assess adverse effect profile stratified by gender. |
0,3 6 month |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
06/10/2025 |
| 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="1"
Months="6"
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
|
Heart failure with reduced ejection fraction (HFrEF) is a major global health concern, and its
prevalence in India is high. SGLT-2 inhibitors, originally for type 2 diabetes, have become a
cornerstone of guideline-directed medical therapy (GDMT) for HFrEF. While large-scale
clinical trials (e.g., DAPA-HF, EMPEROR-Reduced) have demonstrated the significant
benefits of SGLT2i in reducing heart failure hospitalizations and cardiovascular mortality,
some meta-analyses suggest these benefits might be less pronounced in women. This potential
disparity could be due to the underrepresentation of women in clinical trials, coupled with
biological and lifestyle differences. This study aims to address this research gap by evaluating
the real-world effectiveness of SGLT2i in HFrEF patients, with a specific focus on gender
based differences. Patients started on SGLT-2 inhibitors as per eligibility criteria will be enrolled from Cardiology
OPD of PGIMER, Chandigarh. At baseline and at 3- and 6-month follow-ups, a range of
parameters will be assessed, which includes KCCQ-12 questionnaire (primary outcome),
clinical and functional measures like the 6-minute walk test and NYHA class, and key
biomarkers such as NT-proBNP and beta-hydroxybutyrate. The study will also track the
incidence of HF hospitalizations and 3-point MACE, as well as the occurrence of adverse
events. By collecting this comprehensive data, the research seeks to determine if a significant
gender-based difference exists in the clinical benefits, quality of life improvements, and safety
profile of SGLT2 inhibitors in routine clinical practice. This study could significantly influence heart failure guidelines by providing evidence for
gender-specific treatment considerations with SGLT2 inhibitors. Findings may highlight
disparities in patient-reported outcomes between men and women, prompting tailored patient
counselling and a more personalized approach to care. Ultimately, the results will inform future
research and clinical trial designs, ensuring equitable representation and a better understanding
of these therapies for all patients. |