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CTRI Number  CTRI/2023/10/058870 [Registered on: 19/10/2023] Trial Registered Prospectively
Last Modified On: 05/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study in subjects with Symptomatic genetic heart disease comparing sponsors drug Mavacamten with dummy drug. 
Scientific Title of Study   A Randomized Double-blind Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Non-obstructive Hypertrophic Cardiomyopathy 
Trial Acronym  ODYSSEY study 
Secondary IDs if Any  
Secondary ID  Identifier 
2021-005329-26  EudraCT 
CV027031, Protocol Amendment Number 01, date 10APR2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shilpi Sinha 
Designation  Associate Director, Regional Clinical Operations, India Head 
Affiliation  Bristol Myers Squibb 
Address  Bristol Myers Squibb India Pvt. Ltd., One International Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphistone (W), Mumbai
NA
Mumbai
MAHARASHTRA
400013
India 
Phone  2266288645  
Fax  0000000  
Email  shilpi.sinha@bms.com  
 
Details of Contact Person
Scientific Query  
Name  Kartik Doshi 
Designation  Associate Director Medical India 
Affiliation  Bristol Myers Squibb 
Address  Bristol Myers Squibb India Pvt. Ltd., One International Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphistone (W), Mumbai
NA

MAHARASHTRA
400013
India 
Phone  02266288645  
Fax  0000000  
Email  kartik.doshi@bms.com  
 
Details of Contact Person
Public Query  
Name  Shilpi Sinha 
Designation  Associate Director - RCO Head, India 
Affiliation  Bristol Myers Squibb 
Address  Bristol Myers Squibb India Pvt. Ltd, One International Center
NA
Mumbai
MAHARASHTRA
400013
India 
Phone  2266288645  
Fax  0000  
Email  shilpi.sinha@bms.com  
 
Source of Monetary or Material Support  
BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED, One International Centre, 6th floor,Tower 1,Senapati Bapat Marg,Elphistone(W),Mumbai,400013,India 
 
Primary Sponsor  
Name  MyoKardia, Inc. 
Address  1000 Sierra Point Parkway Brisbane, CA 94005, USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Australia
Austria
Brazil
Canada
France
Germany
India
Israel
Japan
Poland
Portugal
United States of America
Belgium
Czech Republic
Denmark
Hungary
Italy
Netherlands
Norway
Spain
United Kingdom  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yash Sharma  Advanced Cardiac Centre PGIMER  Room no-3012, 3rd Floor, Advanced Cardiac Centre Department, Post Graduate Institute Medical Education & Research, Chandigarh 160012
Chandigarh
CHANDIGARH 		 9417167214

ypspgi@gmail.com 
Dr Hisham Ahamed  Amrita Institute of Medical Sciences and Research Centre  Dept. of Cardiology, Amrita Institute of Medical Sciences and Research Centre, Basement Clinical Research Room, AIMS- Ponekkara.P.O, Kochi-68204L, Kerala, India
Ernakulam
KERALA 		 8891242684

ahamed.hisham@gmail.com 
Dr Vivek Chaturvedi  Amrita Institute of Medical Sciences and Research Centre  Clinical Research Department, UG Floor, Admin Block, Mata Amritanandamayi Marg, Sector 88, Faridabad, Haryana, 121002
Faridabad
HARYANA 		 987162464
0000
vivekchaturvedi@fbd.amrita.edu 
Dr Milan Chag  Marengo CIMS Hospital Pvt Ltd.  Marengo CIMS Hospital Pvt Ltd. Plot no 67/1, 2nd floor, west wing, Research Department, opp. panchamrut bungalows, near Shukan mall, Off. science city road, Sola, Ahmedabad, 380060
Ahmadabad
GUJARAT 		 9824022107

milan.chag@cims.me 
Dr Sanjay Mittal  Medanta –The Medicity  Room No. 14, 4th Floor, Medanta-The Medicity, CH Baktawar Singh Road, Sector 38, Near Rajiv Chowk, Islampur Colony, Gurgaon, Haryana 122001, India Gurgaon HARYANA
Gurgaon
HARYANA 		 9910044477

Sanjay.mittal@medanta.org 
Dr Bagirath Raghuraman  Narayana Institute of cardiac sciences Narayana Hrudayalaya Ltd.  Narayana Institute of cardiac sciences, Narayana Hrudayalaya Ltd., Department of Cardiology, No. 258/A, Bommasandra Industrial area, Hosur Road Anekal taluk, Bangalore-560099
Bangalore
KARNATAKA 		 9845144830

bagirath.raghuraman.dr@narayanahealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee of Care Institute Of Medical Science  Approved 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee for ESIC Faridabad   Approved 
Medanta Institutional Ethics Committee  Submittted/Under Review 
Narayana Health Medical Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I422||Other hypertrophic cardiomyopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mavacamten capsules  Frequency - Once daily. Route - oral. Maximum duration of treatment - 120 weeks. All participants will start the double-blind treatment with mavacamten 5 mg or placebo. The dose will subsequently be up-titrated, down-titrated or maintained based on evaluation of LVEF. At Visit 3 (Week 5) and Visit 5 (Week 9), the dose can be decreased based on LVEF. At Visit 7 (Week 12), Visit 11 (Week 24), and Visit 15 (Week 36), the dose can be increased or maintained. Dose increases are designed to be stepwise.  
Comparator Agent  Placebo matching mavacamten oral capsule  Dummy drug given in same manner as Intervention 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1) Diagnosis of HCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines: unexplained left-ventricular hypertrophy with non-dilated ventricular chambers in the absence of other cardiac or systemic disease which can produce the required magnitude of hypertrophy of a maximal LV wall thickness greater than or equal to 15 mm. 2) Peak LVOT pressure gradient < 30 mm Hg at rest and < 50 mm Hg with provocation. 3) New York Heart Association (NYHA) Class II or III. 4) KCCQ-23 CSS Score less than or equal to 80 at screening. 5) LVEF greater than or equal to 60%. 6) CPET: Documented oxygen saturation at rest > 90% at screening. 7) NT-proBNP greater than or equal to 200 pg/mL or BNP greater than or equal to 70 pg/mL. 8) Evidence of myocardial damage or Evidence of LV diastolic dysfunction. 
 
ExclusionCriteria 
Details  1) Known infiltrative or storage disorder causing cardiac hypertrophy that mimics nHCM. 2) History of unexplained syncope within 6 months prior to screening. 3) History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months prior to screening. 4) Paroxysmal or persistent (non-permanent) AF detected at the time of screening. 5) ICD placement or pulse generator change within 2 months prior to screening or planned new ICD placement during the study. 6) Acute heart failure from 4 weeks prior to screening up to randomization. 7) Coronary artery disease requiring intervention. 8) Heart transplant recipient or listed for heart transplant. 9) Currently implanted LV assist device. 10) Clinically significant pulmonary disease associated with exertional dyspnea. 11) Any documented active or suspected malignancy or history of malignancy within 2 years prior to screening. 12) Clinically documented LV aneurysm greater than or equal to 2 cm 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1) To assess the efficacy of a 48-week course of
mavacamten compared to placebo on patient reported health status
2) To assess the efficacy of a 48-week course of
mavacamten compared to placebo on exercise
capacity
 		 1) Change from baseline in KCCQ-23 CSS at Week 4

2) Change from baseline in pVO2 at Week 48 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate the effects of mavacamten on
ventilatory efficiency as measured by the
VE/VCO2 slope 		 Change from baseline in VE/VCO2 slope to Week 48 
Evaluate the effects of mavacamten on NYHA
classification 		 Proportion of participants with at least 1 class of NYHA
improvement from baseline to Week 48 
Evaluate the effects of mavacamten on cardiac
biomarkers of wall stress 		 Change from baseline in NT-proBNP to Week 48 
Evaluate the effects of mavacamten on cardiac
biomarkers of myocardial injury 		 Change from baseline in cTn-T to Week 48 
Evaluate the effects of mavacamten on patient reported shortness of breath  Change from baseline in HCMSQ SoB domain to Week 48 
Evaluate the effects of mavacamten on composite of cardiovascular event  Time to first MACE-plus events defined as any CV death, non-fatal myocardial infarction, non-fatal stroke,
hospitalization for heart failure, hospitalization for
arrhythmias, or appropriate ICD therapy 
 
Target Sample Size   Total Sample Size="420"
Sample Size from India="33" 
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 3 
Date of First Enrollment (India)   06/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/01/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
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   CV027031 is a Phase 3, double-blind, randomized, placebo-controlled, multicenter, international, parallel-group study to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic nHCM. The study will randomize approximately 420 participants at 180 sites in a 1:1 ratio to mavacamten and placebo. Double-blind treatment with oral mavacamten or placebo may range from a minimum of 48 weeks for the last participant randomized to a maximum of 120 weeks for the first participant randomized. At Week 48 after study intervention, the effects of mavacamten compared to placebo on health status (symptoms and physical limitations) will be assessed by change from baseline in KCCQ-23 CSS and the effect on exercise capacity by change from baseline in peak oxygen consumption (pVO2). The 2 primary endpoints were selected to assess the symptoms and functional limitation reported most frequently as troublesome by participants with nHCM: exertional dyspnea, fatigue, and limited exercise capacity.  
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