| CTRI Number |
CTRI/2026/01/100543 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Chart review with cross sectional arm |
| Study Design |
Other |
|
Public Title of Study
|
Uncovering the Burden of Hypertrophic Cardiomyopathy in India: A Multi-center Study on Clinical Burden, Health Care Resource Utilization, and Quality of Life |
|
Scientific Title of Study
|
Hypertrophic Cardiomyopathy: A Burden of Illness Study In India- Retrospective 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 Abhinav Keshwani |
| Designation |
Disease Area Specialist |
| Affiliation |
Bristol-Myers Squibb India Pvt. Ltd. |
| Address |
Bristol-Myers Squibb India Pvt. Ltd.
One International Center, 6th Floor, Tower 1,
Senapati Bapat Marg, Elphinstone (W), Mumbai- 400013
India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
917987000435 |
| Fax |
|
| Email |
Abhinav.Keshwani@bms.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinav Keshwani |
| Designation |
Disease Area Specialist |
| Affiliation |
Bristol-Myers Squibb India Pvt. Ltd. |
| Address |
Bristol-Myers Squibb India Pvt. Ltd.
One International Center, 6th Floor, Tower 1,
Senapati Bapat Marg, Elphinstone (W), Mumbai- 400013
India
MAHARASHTRA
400013
India |
| Phone |
917987000435 |
| Fax |
|
| Email |
Abhinav.Keshwani@bms.com |
|
Details of Contact Person
Public Query
|
| Name |
Jason Williams |
| Designation |
Senior Manager-Market Access and Pricing |
| Affiliation |
Bristol-Myers Squibb India Pvt. Ltd. |
| Address |
Bristol-Myers Squibb India Pvt. Ltd.
One International Center, 6th Floor, Tower 1,
Senapati Bapat Marg, Elphinstone (W), Mumbai- 400013
India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
919769798980 |
| Fax |
|
| Email |
Jason.Williams@bms.com |
|
|
Source of Monetary or Material Support
|
| Bristol-Myers Squibb India Pvt. Ltd.
One International Center, 6th Floor, Tower 1,
Senapati Bapat Marg, Elphinstone (W),
Mumbai- 400013
|
|
|
Primary Sponsor
|
| Name |
Bristol-Myers Squibb India Pvt. Ltd. |
| Address |
Bristol-Myers Squibb India Pvt. Ltd.
One International Center, 6th Floor, Tower 1,
Senapati Bapat Marg, Elphinstone (W), Mumbai- 400013
India
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Narasimhan Calambur |
Asian Institute of Gastroenterology (AIG) Hospital |
OPD Room No-3,4,6, Department-Cardiology, Division-Electrophysiology, Survey No 136, 4/5, Plot No 2/3, Mindspace Rd, P Janardhan Reddy Nagar, Gachibowli, Hyderabad, Telangana 500032
Hyderabad
TELANGANA |
98480 52409
calambur1@gmail.com |
| Dr Hemant Kokone |
B. J. Government Medical College Sassoon General Hospital |
Ward No-73, Department- Cardiology, Division- Interventional Cardiology, Jaiprakash Narayan Road, Near Pune main railway station, Pune, Pin- 411001
Pune
MAHARASHTRA |
9619284398
hemantkokane@gmail.com |
| Dr Dhiman Kahali |
BM Birla Heart Research Centre |
BM Birla Heart Hospital
1, OPD Room No-03, Department-Cardiology, Division-Interventional Cardiology ,1, National Library Ave, Alipore, Kolkata, West Bengal 700027
Kolkata
WEST BENGAL |
9830048563
dhiman.kahali@gmail.com |
| Dr Naveen Bhamri |
Max Super Speciality Hospital |
OPD Room No-1001, Department-Cardiology, Division-Interventional Cardiology, Cardiac Electrophysiology-Pacemaker, FC 50, Max Wali Rd, C and D Block, Shalimar Place Site, Shalimar Bagh, New Delhi, Delhi, 110088
New Delhi
DELHI |
9891429912
naveen.bhamri@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| IEC of B.J .G.M. C And Sassoon General Hospital |
Submittted/Under Review |
| Institutional Ethics Committee Asian Institute of Gastroenterology |
Approved |
| Institutional Ethics Committee B M Birla Heart Research Centre |
Approved |
| Max Healthcare EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I422||Other hypertrophic cardiomyopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 years or more with established diagnosis of HCM at study enrollment (cross sectional survey) or at index date (retrospective).
2. Patients or their caregiver (authorized representative) who are willing and able to sign ICF (cross-sectional survey).
3. Patients with a minimum of 12 months follow-up after index date (retrospective).
|
|
| ExclusionCriteria |
| Details |
1. Patients with no EHRs data available (retrospective).
2. Patients with clinical conditions that mimic HCM (such as amyloidosis, hemochromatosis, sarcoidosis, Fabry disease, etc).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective is to assess the clinical burden (patient’s demographic characteristics, HCM diagnosis, HCM symptoms, NYHA classification, treatment and monitoring, medical history, and fatal CV complications) of HCM (including patients with obstructive HCM and non-obstructive HCM) in India using electronic health records (EHRs) and patient questionnaires |
1 year ( 52 Weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To assess annualized health care resource utilization (HCRU) & associated costs of HCM (including patients with obstructive HCM & non-obstructive HCM) in India using patient, health care professional (HCP), & procurement staff questionnaires. |
1 year (52 Weeks) |
| 2. To assess health related quality of life (HRQoL) in patients with HCM (including patients with obstructive HCM & non-obstructive HCM) in India using patient questionnaires. |
1 year ( 52 Weeks) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/01/2026 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Hypertrophic
cardiomyopathy HCM is a genetic heart disease, inherited in an autosomal dominant
pattern and accounts for 88 percentage of the world population. HCM is one of the most common phenotypes of
cardiomyopathy. HCM is defined as a disease state in which morphologic
expression is confined solely to the heart. It is characterized predominantly
by left ventricular hypertrophy LVH in the absence of another cardiac or systemic or metabolic disease capable of producing the magnitude of
hypertrophy evident in a given patient and for which a disease causing
sarcomere or sarcomere related variant is identified or genetic etiology remains
unresolved.
In India the disease
burden of patients with HCM is not well understood. There are very few
publications articles that capture the burden of HCM in India and no
comprehensive account or publication exists at a national level. Therefore this
study aims to generate evidence on prevalence and mortality from literature clinical
burden health care resource utilization HCRU and health related quality of
life HRQoL especially for patients with obstructive HCM and non obstructive
HCM in India. The data derived from this study could be used for development of
economic modeling such as cost effectiveness analysis budget impact models
etc.This study provides the opportunity to
collect data out of controlled conditions. The study findings can be utilized
for better understanding of the burden of HCM in real world clinical practice.
Although the sample size of included population is small this study will set a
platform for further research on a wider scale with longer follow ups to
provide more robust data on burden of illness of HCM in Indian population.
|