| CTRI Number |
CTRI/2024/07/071165 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational |
| Study Design |
Other |
|
Public Title of Study
|
To Study the Dosage pattern and Demographic characteristics in Heart Failure patients initiated with ARNI in India |
|
Scientific Title of Study
|
A Study Assessing the Dosage pattern and Demographic characteristics in Heart Failure reduced Ejection Fraction patients initiated with Angiotensin Receptor Neprilysin Inhibitor in India (ADD ARNI) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ING_CR_2024_C5, Version 1.0, Date: 16/05/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Mittal |
| Designation |
Consultant Clinical Services |
| Affiliation |
Cipla Ltd |
| Address |
Cipla LTD Bellasis Road
Medical Services Department
Opp. Hotel Sahil Mumbai Central East Mumbai Maharashtra
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9910044477 |
| Fax |
|
| Email |
san_mit@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Zalte |
| Designation |
Senior Team Lead Vitalis |
| Affiliation |
Cipla Ltd |
| Address |
Cipla LTD Bellasis Road
Medical Affairs MSD C wing First floor
Opp. Hotel Sahil Mumbai Central East Mumbai Maharashtra
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9004687211 |
| Fax |
|
| Email |
nitin.zalte@cipla.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Zalte |
| Designation |
Senior Team Lead Vitalis |
| Affiliation |
Cipla Ltd |
| Address |
Cipla LTD Bellasis Road
Medical Affairs MSD C wing First floor
Opp. Hotel Sahil Mumbai Central East Mumbai Maharashtra
MAHARASHTRA
400008
India |
| Phone |
9004687211 |
| Fax |
|
| Email |
nitin.zalte@cipla.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Cipla Limited |
| Address |
Cipla LTD Bellasis Road Opp Hotel Sahil Mumbai Central East Mumbai 400008 |
| 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 Sanjay Mittal |
Cipla Limited |
Cipla House Peninsula Business Medical Services Department Park Ganapatrao Kadam Marg Lower Parel West
Mumbai
MAHARASHTRA |
9910044477
san_mit@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksha-Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I509||Heart failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender or aged more than 18 years
Patients with documented heart failure with reduced left ventricular ejection fraction less than 40 percent not more than 3 months prior to enrolment
Patients with NYHA class II IV and not hospitalized in the past 1 month prior to enrolment
ARNi naïve symptomatic, chronic HFrEF patients which includes recently diagnosed patients OR stable chronic HFrEF patients
Patients eligible for initiation of ARNi therapy as per the clinical judgement of the treating physician
Provide written informed consent |
|
| ExclusionCriteria |
| Details |
Patients who are deemed ineligible for this study at the discretion of the treating physician
Pregnant and Lactating female
Patients with acute decompensated heart failure
Patients with Hyperkalemia potassium level more than or equal to 5.30 mmol per Litres within the past 2 weeks
Patients are currently participating in another clinical study |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the dosage pattern and treatment persistence with ARNi therapy in HFrEF patients in India |
Baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To describe the medication dosage pattern and the implementation of GDMT in HFrEF patients who are initiated with ARNi
To evaluate the safety of ARNi therapy
To evaluate the effectiveness of ARNi therapy |
Baseline and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="2347" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/08/2024 |
| Date of Study Completion (India) |
02/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This observational study aims to provide insights into the real-world usage patterns of Angiotensin Receptor Neprilysin Inhibitor (ARNi) therapy in patients with Heart Failure with reduced Ejection Fraction (HFrEF) in India. The primary focus is on understanding the dosage patterns and treatment persistence among these patients. Additionally, the study will document the implementation of Guideline-Directed Medical Therapy (GDMT) and assess both the safety and effectiveness of ARNi therapy in this population. The findings will contribute to better clinical decision-making and optimized patient care for HFrEF in the Indian context. |