| CTRI Number |
CTRI/2025/11/096770 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Metaprolol and Bisoprolol with Dapagliflozin in patients with Heart Failure. |
|
Scientific Title of Study
|
Comparative Evaluation of Metaprolol Succinate-Dapagliflozin versus Bisoprolol Fumarate-Dapagliflozin on NT-proBNP level in Heart Failure with reduced Ejection Fraction [HFrEF] Patients: A Randomized Open Label Prospective 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 Surya Prakash S |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology, Kattankulathur |
| Address |
Department of Cardiology, SRM Medical College Hospital and Research Center, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu District, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9787911171 |
| Fax |
|
| Email |
suryaprs@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagadeesan M |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of Science and Technology, Kattankulathur |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu District, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7449277556 |
| Fax |
|
| Email |
jagadeem1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms Hindhusha K V |
| Designation |
Student |
| Affiliation |
SRM Institute of Science and Technology, Kattankulathur |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu District, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9150858298 |
| Fax |
|
| Email |
hk3777@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College and Research Center, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu District, Tamil Nadu-603203, India |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital and Research Center. |
| Address |
SRM Institute of Science and Technology, Kattankulathur, Chengalpattu District, Tamil Nadu, India- 603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Surya Prakash S |
Department of Cardiology, SRM Medical College Hospital and Research Centre |
SRM Institute of Science and Technology, Kattankulathur - 603203
Kancheepuram
TAMIL NADU |
9787911171
suryaprs@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Center, Institutional Ethics Committee. |
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 |
Bisoprolol Fumarate + Dapagliflozin |
Bisoprolol Fumarate (1.25-10mg) + Dapagliflozin (10mg) OD for 12 weeks
Beta blockers titrated to maximum tolerated dose |
| Comparator Agent |
Metoprolol Succinate + Dapagliflozin |
Metoprolol Succinate (12.5-200mg) + Dapagliflozin (10mg) OD for 12 weeks
Beta blockers titrated to maximum tolerated ose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient aged 18-80 years with diagnosed HFrEF greater than or equal to 1month, Left ventricular Ejection Fraction lesser than or equal to 40%, NYHA Functional Class II or above, NT-proBNP Level concentration greater than or equal to 600pg/ml, Stable on standard Guideline-directed medical therapy, patient willing and able to provide written informed consent will be included. |
|
| ExclusionCriteria |
| Details |
Symptomatic hypotension or Systolic blood pressure less than 95mmHg, Recent diagnosis with Myocardial Infarction, Unstable Angina, stroke or Transient ischemic attack, Patient with Type 1 Diabetes mellitus or Diabetic Keto Acidosis, Previous history of Urinary Tract infection, Lactating and pregnant women, Contraindications to beta blockers or dapagliflozin, eGFR lesser than or equal to 30 mL/min/1.73 m² will be excluded.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the efficacy of two commonly used Beta blockers (Metoprolol succinate and Bisoprolol fumarate) in combination with Dapagliflozin on NT-proBNP level in improving Left Ventricular Ejection Fraction [LVEF] among Heart Failure with reduced ejection fraction [HFrEF] patients. |
ECHO: Week 0, Week 6,Week 12
NTproBNP: Week 0 and Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To access the quality of life of the patient during the study period using Health Related Quality of Life [HRQOL] Questionnaire, To identify the incidence of adverse events (if any) during the study period, To evaluate treatment adherence and compliance at every follow ups.
|
HRQOL questionnaire: Week 6 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| Date of Study Completion (India) |
31/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This randomized, open-label, prospective study aims to assess the efficacy of Metoprolol Succinate–Dapagliflozin versus Bisoprolol Fumarate–Dapagliflozin in 60 patients with HFrEF. Patients fulfilling inclusion/exclusion criteria will be recruited and consent obtained. Eligible participants will undergo baseline evaluation, including NT-proBNP levels, ECHO, NYHA class, HbA1C and eGFR level. Patients will then be randomized into two groups (30 each) using block randomization (1:1) and treated for 12 weeks. Group A: Metoprolol Succinate (12.5-200mg) + Dapagliflozin (10mg) once a day for 12 week Group B: Bisoprolol Fumarate (1.25-10mg) + Dapagliflozin (10mg) once a day for 12 weeks Follow-up assessments will include ECHO at week 6 & 12 and NT-proBNP at week 12, along with monitoring of Quality of life and ADR. Finally, data will be statistically analyzed and documented at the end of the study assessment.
|