| CTRI Number |
CTRI/2024/09/074204 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trial to check the effectiveness and safety of brand sacubitril and Valsartan along with generic sacubitril and valsartan in patients of Heart failure. |
|
Scientific Title of Study
|
A prospective, randomized, active controlled, crossover, investigator-initiated study comparing the efficacy and safety of innovator sacubitril and valsartan along with generic sacubitril and valsartan in patients of Heart Failure with Reduced Ejection Fraction (HFrEF). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IIS/AZ/01 Version 01 Dated 04-09-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Head – Medical Services |
| Affiliation |
Clinexcel Research |
| Address |
297 / 301, 2nd floor, Clinical research room, SoBo Centre,
South Bopal,
Ahmadabad
GUJARAT
380058
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Head – Medical Services |
| Affiliation |
Clinexcel Research |
| Address |
297 / 301, 2nd floor, Clinical research room, SoBo Centre,
South Bopal,
GUJARAT
380058
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Head – Medical Services |
| Affiliation |
Clinexcel Research |
| Address |
297 / 301, 2nd floor, Clinical research room, SoBo Centre,
South Bopal,
GUJARAT
380058
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
|
Source of Monetary or Material Support
|
| Investigator Initiated Study (Room No. 08, Burns Ward, 02nd Floor, V.s. Hospital, Paldi, 380006, Gujarat, India :Dr. Sandarbh Patel)
|
|
|
Primary Sponsor
|
| Name |
Dr Sandarbh Patel |
| Address |
Room No. 08, Burns Ward, 02nd Floor, Paldi, V.S.. Hospital, Paldi, Ahmedabad. 380006, Gujarat, India.
|
| Type of Sponsor |
Other [[ Self (Principal Investigator) ]] |
|
|
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 Sandarbh Patel |
Seth Vadilal Sarabhai General Hospital |
Room No. 08, Burns Ward, 02nd Floor, Paldi
Ahmadabad
GUJARAT |
9909031385
drsandarbh.cardio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aatman Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I502||Systolic (congestive) heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AZMARDA 50mg |
One Tablet twice daily for 08 weeks |
| Comparator Agent |
SACURISE 50mg |
One Tablet twice daily for 08 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either gender between 18-75 years of age with a confirmed diagnosis of HFrEF (left ventricular ejection fraction (LVEF) less than or equal to 45%), based on echocardiography.
2. Patients having a left ventricular Global Longitudinal Strain (GLS) Score of more than or equal to 15 measured through speckle-tracking echocardiography (STE) or 2D echocardiography.
3. Patients with HFrEF who have not previously been treated with Sacubitril/Valsartan
4. Patients who are on stable doses of beta blockers,
mineralocorticoids and or SGLT2 inhibitors since last 4 weeks
5. Patients willing to be enrolled for the study and able to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Patient with known hypersensitivity to Sacubitril/Valsartan or any component of the formulation.
2.Patients receiving concomitant medications that interfere with Sacubitril/Valsartan.
3.Known patients with moderate renal impairment (eGFR less than 60 mL/min/1.73 m²) or significant liver disease (Child-Pugh B or C).
4.Patient with Uncontrolled hypertension (blood pressure more than 160/100 mmHg) or clinically significant arrhythmias.
5.Patients who have used Sacubitril/Valsartan within the last 4 weeks.
6.Patients who have participated in another clinical trial within the last 30 days.
7.Pregnant or breastfeeding women, or women of childbearing potential who are not using effective contraception.
8.Patients unwilling or unable to comply with the study protocol and requirements.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the GLS score of both arms |
at the end of week 8 as compared to baseline (Day 0) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the GLS score of both arms |
1. At the end of Week 12 & 16 compared to Week 8
2. At the end of week 4 vs Baseline |
| Change in the GLS (A2C, A4C, ALAX) score and Average Time to Peak (TTP) value of both arms |
At the end of Week 12 & 16 compared to Week 8 |
| Change in the GLS (A2C, A4C, ALAX) score and Average TTP value of both arms |
At the end of Week 04 & 08 compared to Baseline |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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 4 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="3"
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
|
In this study, patients with an established diagnosis of Heart Failure with Reduced Ejection Fraction (HFrEF) will be screened and enrolled if eligible (Visit 1 - Baseline). Eligible patients will be randomly assigned to one of two treatment arms in a 1:1 ratio to receive either the innovator Sacubitril/Valsartan formulation or the generic Sacubitril/Valsartan formulation. The study will follow a crossover design, where each patient will receive one formulation for the first 8 weeks and then switch to the alternate formulation for the remaining 8 weeks. The study duration will be 16 weeks, with scheduled visits at the end of Week 4 (Visit 2 - Follow-up), Week 8 (Visit 3 - Crossover), Week 12 (Visit 4 - Follow-up), and Week 16 (Visit 5 - End of Study). All enrolled patients will be instructed to take the assigned study medication twice daily (BID) for the entire duration of the 16-week study period, with continuous monitoring for efficacy and safety parameters at each visit. |