| CTRI Number |
CTRI/2025/07/090940 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Real-world data collection on vericiguat treatment in patients with heart failure to study the behavior of the medicine. |
|
Scientific Title of Study
|
Retrospective, non-interventional database study for the
evaluation of real-world drug use patterns, clinical
characteristics and clinical outcomes in patients initiated on
Vericiguat in India |
| 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 Disha Gupta |
| Designation |
Therapy Head |
| Affiliation |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer Pharmaceuticals Private Limited Bayer House Central Avenue
Hiranandani Estate Thane west
Thane
MAHARASHTRA
400607
India
Thane
MAHARASHTRA
400607
India |
| Phone |
8724030192 |
| Fax |
|
| Email |
disha.gupta@bayer.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Disha Gupta |
| Designation |
Therapy Head |
| Affiliation |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer Pharmaceuticals Private Limited Bayer House Central Avenue
Hiranandani Estate Thane west
Thane
MAHARASHTRA
400607
India
Thane
MAHARASHTRA
400607
India |
| Phone |
8724030192 |
| Fax |
|
| Email |
disha.gupta@bayer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Disha Gupta |
| Designation |
Therapy Head |
| Affiliation |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer Pharmaceuticals Private Limited Bayer House Central Avenue
Hiranandani Estate Thane west
Thane
MAHARASHTRA
400607
India
Thane
MAHARASHTRA
400607
India |
| Phone |
8724030192 |
| Fax |
|
| Email |
disha.gupta@bayer.com |
|
|
Source of Monetary or Material Support
|
| Bayer Zydus Pharma Private Limited (BZPPL) India, Bayer House, Central Avenue 400607 Thane India |
|
|
Primary Sponsor
|
| Name |
Bayer Zydus Pharma Pvt Ltd |
| Address |
Bayer Zydus Pharma Private Limited Research & Development,
Pharmaceuticals Bayer House, Central Avenue 400607 Thane,
Maharashtra India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bayer Pharmaceuticals Pvt Ltd |
Bayer House, Central Avenue Hiranandani Estate, Thane, (west) (India) - 400607 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 18 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Seth |
All India Institute of Medical Sciences |
All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI |
919910630120
drsandeepseth@gmail.com |
| Dr Sreekant Reddy |
Apollo DRDO Hospitals |
Apollo DRDOHospitals, DMRL X Roads, Kanchanbagh, Hyderabad-500058
Hyderabad
TELANGANA |
919247431815
rondlasr@yahoo.com |
| Dr Prasant Kumar Sahoo |
Apollo Hospital Enterprise Limited |
Apollo Hospital Enterprise Limited, : Plot No-251, Sainik School Road, Unit- 15, Bhubaneswar-75 1005, Odisha, India.
Khordha
ORISSA |
918093060049
drprasant_s@apollohospitals.com |
| Dr Abraham Oomman |
Apollo Hospitals |
no 21, greams lane, off greams road, Chennai - 600006
Chennai
TAMIL NADU |
9841174578
abrahamoommandr@gmail.com |
| Dr Aftab Khan |
Apollo Multispeciality Hospitals |
Apollo Multispeciality Hospitals 58, Canal Circular Road, Kolkata – 700054
Kolkata
WEST BENGAL |
919831257844
cardiokhan@gmail.com |
| Dr Kamal Sharma |
Cardiology Clinic |
A/406, Shivalik Yash, 132 Feet Ring Road, Opp Shashtri Nagar BRTS bus stand, Naryanpura 380013
Ahmadabad
GUJARAT |
9426020154
kamalcardiodoc@gmail.com |
| Dr Dheeraj Kumar Gandotra |
Dr. B.L. Kapur Memorial Hospital |
Pusa Rd, Radha Soami Satsang, Rajinder Nagar,
Delhi, 110005
New Delhi
DELHI |
9818994853
gandotradheeraj@gmail.com |
| Dr Rajat Sharma |
Fortis Hospital |
Fortis Hospital, Phase-8, Sector-62, Mohali, 160062, Punjab.
Chandigarh
CHANDIGARH |
918283812952
rajat.dr@gmail.com |
| Dr Dhiraj Kumar |
K.E.M. HOSPITAL & SETH G.S. MEDICAL COLLEGE |
K.E.M. HOSPITAL & SETH G.S. MEDICAL COLLEGE, 4th Floor, CVTC Building, Dept of Cardiology, Acharya Donde Marg, Parel 400012, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
917506721222
drdhirajkumar_cr@gmail.com |
| Dr K P Suresh |
Kauvery Hospital |
TTK road, Alwarpet, Chennai
Chennai
TAMIL NADU |
9840046434
kpscardio@yahoo.co.in |
| Dr Jabir Abdullakutty |
Lisie Hospital |
Lisie Hospital, Kochi, kerala - 682018
Ernakulam
KERALA |
9447011773
drjabi@yahoo.co.in |
| Dr Anish Chandarana |
Marengo CIMS Hospitals Pvt. Ltd |
MarengoCIMS Hospitals Pvt. Ltd, Plot No. 67/1, Opp. Panchamrut Bunglows, Near Shukan Mal, Off. Science City Road, · Sola, Ahmedabad – 380060.
Ahmadabad
GUJARAT |
919825096922
anish.chandarana@cims.me |
| Dr Viveka Kumar |
Max Super Speciality Hospital |
Max Super Speciality Hospital, Saket (East Block) A Unit of Devki Devi Foundation, 2, Press Enclave road, Saket, New Delhi - 110017
New Delhi
DELHI |
919871001190
viveka.kumar@maxhealthcare.com |
| Dr Praveen Chandra |
MEDANTA-THE MEDICITY |
MEDANTA-THE MEDICITY, SECTOR-38, Gurgaon, Haryana. 122001.
Gurgaon
HARYANA |
919810125370
praveen.chandra@medanta.org |
| Dr K Jai Shankar |
Medway Hospital |
Medway Heart Institute, 2, 26, 1st Main Rd, United India Colony, Kodambakkam, Chennai, Tamil Nadu 600024
Chennai
TAMIL NADU |
9791044123
drkjs68@yahoo.com |
| Dr Jagdish Hiremath |
Ruby Hall Clinic |
Grant Medical Foundation, 40, Sassoon road, Pune - 411001
Pune
MAHARASHTRA |
9822022441
drjagdishhiremath@gmail.com |
| Dr Ashwani Mehta |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital, A1, Sarhadi Gandhi Marg, Old Rajinder Nagar, New Delhi, Delhi, 110060
New Delhi
DELHI |
919811057384
drashwanimehta@gmail.com |
| Dr Pankaj Jariwala |
Yashoda Healthcare Services Private Limited |
Yashoda Healthcare Services Private Limited
Raj bhavan Road, Somajiguda, Hyderabad, Telangana-500082
Hyderabad
TELANGANA |
9393178738
docpjariwala@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee of care institute of medical sciences |
Approved |
| Institute Ethics Committee |
Submittted/Under Review |
| Institutional Ethics committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee Devki Devi Foundation |
Approved |
| Institutional Ethics committee- Clinical Studies |
Submittted/Under Review |
| Institutional Ethics Committee-Clinical Studies |
Submittted/Under Review |
| Medanta Institutional Ethics Committee (MIEC) |
Submittted/Under Review |
| Sir Ganga Ram Hospital Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I508||Other heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vericiguat |
Patients who have been prescribed Vericiguat 2.5 mg
Vericiguat 5 mg
Vericiguat 10 mg from 1st Sep 2022 until 31st Aug 2023 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ≥18 years age.
Patients who are prescribed as per local label will be included in the study.
At least one Vericiguat prescription during the time between 1st Sep2022 and 31st Aug
2023. |
|
| ExclusionCriteria |
| Details |
Subjects who have participated in an interventional clinical study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To describe the baseline clinical characteristics e.g.,
demographics, concomitant medication, medical
history and surgical history, history of
hospitalization, NT-proBNP levels) & treatment
patterns of patients initiated on Vericiguat.
• To describe the use of medications of interest
(yes/no) before/after initiation of Vericiguat as well
as the prescribed amount of medications in
respective periods.
• To describe the measures for titration patterns
(Starting dose, up-titration / down-titration (yes/no),
time until target dose).
• To describe the no. of patients who have
discontinued treatment, time points of
discontinuation, reasons for discontinuation
(Symptomatic hypotension, syncope).
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To describe the clinical outcome of patients initiated on
Vericiguat in real world setting.
• Hospitalization rate due to HF after Vericiguat
initiation
• CV mortality rate
• Composite of HF hospitalization and CV mortality
• Overall frequency and incidence of symptomatic
hypotension and syncope after vericiguat initiation |
6 months |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
28/07/2025 |
| 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)
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
|
Vericiguat is a first in class soluble guanylate cyclase (sGC) stimulator that is indicated for reducing the risk of cardiovascular death and hospitalization for heart failure (HF) in adults who have symptomatic chronic heart failure or in adults with an ejection fraction of less than 45% who have recently been hospitalized for heart failure, that has been approved by the U.S. Food & Drug Administration (FDA) in January 2021 and approved in India in February 2022. On the basis of the VICTORIA trial, Vericiguat is specifically recognized for the management of Worsening Heart Failure (WHF) in recent guidelines for heart failure with reduced ejection fraction (HFrEF). The recommended starting dose of Vericiguat is 2.5 mg orally once daily with food which is to be doubled approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient.[¹,²,³] Vericiguat enhances the cyclic guanosine monophosphate (GMP) pathway by directly stimulating soluble guanylate cyclase through a binding site independent of nitric oxide, and it sensitizes soluble guanylate cyclase to endogenous nitric oxide by stabilizing nitric oxide binding to the binding site. The nitric oxide-sGC-cGMP pathway is important in the development and progression of heart failure but is relatively unexplored. No other disease-modifying heart failure drugs act on this pathway. HF with reduced ejection fraction (HFrEF) is the most prevalent type of HF in India, as seen in the recent Trivandrum HF registry. The in-hospital mortality and all-cause mortality rate is higher in patients with HFrEF. HF leads to 1.8 million hospitalizations each year in India. According to the Manipal Heart Failure Registry (MHFR), the average length of a hospital stay for HF during the initial admission is 5.3 ± 2.9 days and the average overall cost per patient is 1.3 Lakh INR. Although chronic HF management has improved significantly, heart failure remains a progressive clinical syndrome with a poor prognosis, leading to millions of hospitalizations worldwide. Although there is currently a limited real-world data on usage of Vericiguat, discussing the early initiation of Vericiguat in different patient profiles with worsening HF can assist clinicians in managing these patients effectively. Identifying diverse patient profiles that would benefit from Vericiguat therapy is essential. Currently vericiguat is approved in India for the management of worsening heart failure in patients with chronic HFrEF with left ventricular ejection fraction (LVEF) <45%. This retrospective data analysis will help generate insights and inform clinicians on clinical characteristics of patients initiated on Vericiguat, drug utilization patterns and the initial outcomes observed in real world setting. The study’s results will help health care professionals (HCP’s) identify right patient profiles for Vericiguat initiation, leading to optimal management of WHF, thereby reducing HF hospitalization and mortality. |