| CTRI Number |
CTRI/2023/10/058403 [Registered on: 06/10/2023] Trial Registered Prospectively |
| Last Modified On: |
05/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
EMR study |
| Study Design |
Other |
|
Public Title of Study
|
To understand usage pattern, and effectiveness of sacubitril/valsartan in heart failure |
|
Scientific Title of Study
|
Retrospective, electronic medical records (EMR) based study to understand usage pattern and effectiveness of sacubitril/valsartan in heart failure |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
B Swathi Reddy |
| Designation |
Trial coordinator |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27
Ameerpet Hyderabad 500016 Telangana India, Hyderabad, TELANGANA, 500016, India
Hyderabad
TELANGANA
500016
India |
| Phone |
8374255466 |
| Fax |
|
| Email |
swathibrb@drreddys.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simran Chhatwal |
| Designation |
Medical Advisor |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27
Ameerpet Hyderabad 500016 Telangana India, Hyderabad, TELANGANA, 500016, India
Hyderabad
TELANGANA
500016
India |
| Phone |
9582711359 |
| Fax |
|
| Email |
simranchhatwal@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Rathod |
| Designation |
Medical Cluster Head Ideation and CR Medical Affairs |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27
Ameerpet Hyderabad 500016 Telangana India, Hyderabad, TELANGANA, 500016, India
Hyderabad
TELANGANA
500016
India |
| Phone |
9987246597 |
| Fax |
|
| Email |
rahul.rathod@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad 500016, Telangana India |
|
|
Primary Sponsor
|
| Name |
Dr Reddys Laboratories Ltd |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27
Ameerpet Hyderabad 500016 Telangana India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Syed Mujtaba |
Dr Reddys Laboratories |
7-1-27, GG India, Ameerpet
Hyderabad
TELANGANA |
7032969523
mujtabanaqvi@drreddys.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S2J INDEPENDENTETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I462||Cardiac arrest due to underlying cardiac condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Heart failure Patients who have been prescribed with CIDMUS and ejection fraction (EF) value are reported at baseline.
2.Patients of either sex ≥18 years of age |
|
| ExclusionCriteria |
| Details |
Patients for whom EF value is not reported at baseline |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the usage of sacubitril/valsartan across different
ranges of EF (≤40%, 41-49%, ≥50%) – signifying HF with
reduced EF (HFrEF), HF with moderately reduced EF
(HFmrEF), & HF with preserved EF (HFpEF), respectively.
2.To understand baseline demographics – patients’ age, gender,
body mass index (BMI), systolic blood pressure (SBP),
diastolic blood pressure (DBP), comorbid conditions and
concomitant medications like beta blocker [BB],
mineralocorticoid receptor antagonist [MRA], Sodium-glucose cotransporter-2 [SGLT2] inhibitors and
combinations) as monotherapy and/or combination therapy in
HF patients on sacubitril/valsartan. |
2017 to 2023
(Data will be captured for one consecutive follow-up visit from the baseline visit/index
date) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• The effect of CIDMUS on change in EF from baseline
• Change in SBP, & DBP from baseline to follow up visits
• Change in potassium levels from baseline to follow up visit
• Average dose & dose titrations of CIDMUS
|
2017 to 2023
(Data will be captured for one consecutive follow-up visit from the baseline visit/index
date) |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
31/10/2023 |
| 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="6"
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
|
Real-world, retrospective, multicenter, EMR-based study. Retrospective, electronic medical records (EMR) based study to understand usage pattern and effectiveness of CIDMUS in heart failure.Heart failure Patients prescribed with sacubitril/valsartan and whose ejection fraction (EF) value are available at baseline.The medical records of the patients meeting the eligibility criteria will be taken into consideration. Patient profiling will be done at the baseline. One follow-up visit (consecutive) post prescription of sacubitril/valsartan will be tracked to assess the effectiveness, tolerability, and dose titration – depending on the availability of the data. |