CTRI/2024/03/064528 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On:
29/01/2025
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Real-World Evidence Study
Study Design
Single Arm Study
Public Title of Study
A study to understand Effectiveness and safety of CIDMUS tablets in Heart Failure with reduced and Mid-range ejection fraction patients
Scientific Title of Study
A prospective, observational, multicenter Real-World Evidence study to assess the effectiveness & safety of CIDMUS (sacubitril - valsartan) in Heart Failure with reduced Ejection Fraction (HFrEF) and Heart Failure with mid-range ejection fraction (HFmrEF) patients in India.
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
DRL-IND-GGI-045-CIDM/2023 Version 1.0 dated 19-Dec-2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sagar Katare
Designation
Medical Cluster Head- CR
Affiliation
Dr. Reddy’s Laboratories Limited
Address
Dr. Reddy’s Laboratories Limited
8-2-337, Road No. 3, Banjara Hills, Hyderabad
Hyderabad TELANGANA 500034 India
Phone
9223772427
Fax
Email
sagarkatare@drreddys.com
Details of Contact Person Scientific Query
Name
Dr Sagar Katare
Designation
Medical Cluster Head- CR
Affiliation
Dr. Reddy’s Laboratories Limited
Address
Dr. Reddy’s Laboratories Limited
8-2-337, Road No. 3, Banjara Hills, Hyderabad
Hyderabad TELANGANA 500034 India
Phone
9223772427
Fax
Email
sagarkatare@drreddys.com
Details of Contact Person Public Query
Name
Dr Sagar Katare
Designation
Medical Cluster Head- CR
Affiliation
Dr. Reddy’s Laboratories Limited
Address
Dr. Reddy’s Laboratories Limited
8-2-337, Road No. 3, Banjara Hills, Hyderabad
Hyderabad TELANGANA 500034 India
Phone
9223772427
Fax
Email
sagarkatare@drreddys.com
Source of Monetary or Material Support
Dr. Reddy’s Laboratories Limited
Primary Sponsor
Name
Dr. Reddy’s Laboratories Limited
Address
Address: 8-2-337, Road No. 3, Banjara Hills, Hyderabad, Telangana – 500034, India
6th floor, Research Department, Plot no 121, Lane no 4,
Dahanukar colony, Kothrud, Pune 411038, Maharashtra, India. Pune MAHARASHTRA
9850465007
drashish.deoyanihospital@gmail.com
Dr Tejas Shah
Dr M K Shah Medical College and Research Centre and SMT. S.M.S Multispeciality Hospital
Block B, Room No 04, Ground Floor, Medicine OPD,
Visat Gandhinagar Highway, Near Tapovan Circle, Chandkheda, Ahmedabad - 382424, Gujarat, India Ahmadabad GUJARAT
8951274202
tejaschaitri@gmail.com
Dr Ram Chitlangia
Jeevan Rekha Critical Care and Trauma Hospital
Room Number 04, Ground floor, Department of Cardiology, Jeevan Rekha Critical Care and Trauma Hospital, Jeevan Rekha Marg, S-24, Mahal Yojana, Jagatpura, Jaipur-302025, Rajasthan , India Jaipur RAJASTHAN
9001729240
drramchitlangia525@gmail.com
Dr Sanjay Khandelwal
Khandelwal Heart Hospital
Room Number 01, Ground Floor, Department of Cardiology, Khandelwal Heart Institute, Plot No MS2, Opposite VKI Road, 3, Sikar Road, Jaipur, Rajasthan-302039 Jaipur RAJASTHAN
9530273721
drsanjaykhandelwal07@gmail.com
Dr Siddhant Trehan
Maharaja Agrasen Hospital
First floor, Cathlab, Department of Cardiology, , Maharaja Agrasen Hospital, West Punjabi Bagh, New Delhi-110026, India New Delhi DELHI
9810700089
siddhanttrehan@gmail.com
Dr Kartik Bhosale
Medipoint Hospitals Pvt. Ltd.
241/1, New D.P Road,
Clinic building 3rd floor, Research Department,
Near Sai Heritage, Aundh, Pune 411007, Maharashtra India.
Pune MAHARASHTRA
8826429101
drkartik.medipoint@gmail.com
Dr K Jaishankar
Medway Heart Institute
Consultation room no 2, basement, cardiology department,
Medway Heart Institute, 9, First Main Road, United India Colony,
Kodambakka, Chennai, Tamilnadu 600024 Chennai TAMIL NADU
9791044123
drkjs68@gmail.com
Dr Kamal Sharma
Sanjivani Superspeciality Hospital
OPD No 07, First Floor, Cardiology Department, 1-Uday Park Society,
Nr Sunrise Park, Vastrapur, Ahmedabad-380015 Gujarat India.
Ahmadabad GUJARAT
3rd floor, Research Department Valji Ladha Road,
Near Kalidas Natya Gruh, Mulund West, Mumbai,
Maharashtra- 400080 India. Mumbai MAHARASHTRA
9769521394
dryogesh.hmnh@gmail.com
Dr Vijayakumar
Vijaya Medical & Educational Trust
Vijaya Medical and educational trust, Consulting Room, Medical ward,
1st floor, Clinical Research department,
No :434 & 323 ,NSK salai, Vadapalani, Chennai, Tamilnadu,600026 Chennai TAMIL NADU
1.Male or female patients of Age greater or equal to 18 years
2.Patients diagnosed with Heart Failure with Ejection fraction lessthan 50% at baseline, who were prescribed CIDMUS for the first time or within one week.
3.Patients willing to provide consent to participate in the study
ExclusionCriteria
Details
1. Contraindications to the study drug as per physician’s discretion.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Change in Ejection Fraction from baseline visit to follow-up visits 1,3,6, and 12 months in Heart failure patients on CIDMUS as per below sub groups
1,3,6 and 12 months
Secondary Outcome
Outcome
TimePoints
1. Safety assessment - Frequency and severity of AEs
2.Emergency visits due to HF requiring inotropic agents/iv diuretics at 1, 3,6, and 12 months
3.Incidence of hospitalization in HFrEF and HFmrEF patients on CIDMUS at 1,3,6, and 12 months
4.Incidence of cardiac death in HFrEF and HFmrEF patients on CIDMUS at 1,3,6, and 12 months
5.Change in NT-proBNP from baseline visit to follow-up visits 1,3,6, and 12 months in HFrEF and HFmrEF patients on CIDMUS
6. Change in NYHA class from baseline to 1,3,6, and 12 months in HFrEF and HFmrEF patients on CIDMUS
7.Average dose of the drug prescribed & compliance to therapy
1,3,6, and 12 months
Target Sample Size
Total Sample Size="200" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
This is a prospective, observational, multicenter real-world evidence, single-arm study. The study aims to assess the effectiveness and safety of CIDMUS in both HFrEF (EF less than or equal to 40%) and HFmrEF (EF: 41% - 49%) patients, with a total enrollment of 200 subjects at baseline. The study will be carried out in India, across 10 sites in 4-6 cities with subjects who have been prescribed CIDMUS for the first time or within one week. The study comprises subjects who are at least 18 years “ old or above with a 12-month follow-up period. Potential subjects will be screened for eligibility. After meeting the eligibility criteria, the subjects will be enrolled in the study and will be assigned a Unique Identification Number (UIN) to maintain confidentiality. Subjects will be evaluated at Month 1, Month 3, Month 6, and Month 12. Safety will be assessed throughout the study period for 12 months.