| CTRI Number |
CTRI/2024/08/072999 [Registered on: 27/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparative study of three Calcium channel blockers in Hypertension by 24 hour BP monitoring |
|
Scientific Title of Study
|
Comparison of the Efficacy of 24 Hour BP Control of Azelnidipine, Amlodipine and Cilnidipine in Mild to Moderate Essential Hypertension – a Prospective Multi-centric Parallel Arm Real-world Study (AMCILAZ-EH Study) |
| Trial Acronym |
AMCILAZ-EH Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DPrabhakar |
| Designation |
Cardiologist |
| Affiliation |
Ashwin Clinic |
| Address |
AC Block 38,
Fourth Street
Annanagar, Chennai- 600040
Chennai
TAMIL NADU
600040
India |
| Phone |
9884012727 |
| Fax |
|
| Email |
prabhud19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DPrabhakar |
| Designation |
Cardiologist |
| Affiliation |
Ashwin Clinic |
| Address |
AC Block 38,
Fourth Street
Annanagar, Chennai- 600040
Chennai
TAMIL NADU
600040
India |
| Phone |
9884012727 |
| Fax |
|
| Email |
prabhud19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DPrabhakar |
| Designation |
Cardiologist |
| Affiliation |
Ashwin Clinic |
| Address |
AC Block 38,
Fourth Street
Annanagar, Chennai- 600040
Chennai
TAMIL NADU
600040
India |
| Phone |
9884012727 |
| Fax |
|
| Email |
prabhud19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Associates for Cardiology Education and Research in Tamilnadu(ACERT) |
|
|
Primary Sponsor
|
| Name |
Associates for Cardiology Education and Research in Tamilnadu(ACERT) |
| Address |
AC Block 38, Fourth Street,
Annanagar, Chennai
India - 600040 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Asha Mahilmaran |
A.M. Cardiopulmonary Clinic |
Consultation Room No 1,
Cardiology Department,
88, Thandavarayan Mudali st, Washermanpet, Chennai-600021
Chennai
TAMIL NADU |
9841010281
drashamahil@gmail.com |
| Dr Prabhakar Dorairaj |
Ashwin Clinic |
Main Consultation Room(1),
Department of Cardiology,
AC block 38, 4th st, Anna Nagar, Chennai-600040
Chennai
TAMIL NADU |
9884012727
prabhud19@gmail.com |
| Dr K Kannan |
Ashwini Soundara Hospital and Research Centre |
Consultation Room No 2,
Department of Cardiology,Ground Floor,
Ashwini Soundara Hospital and Research Centre,
24, Kasturi Rangan Road, Kasturi Estate, Teynampet, Chennai-600018
Chennai
TAMIL NADU |
9094011522
manju_kannan2000@yahoo.co.in |
| Dr S Ramesh |
Avadi Heart Centre |
Room Number 1,
Department of Cardiology,
Avadi Heart Centre, Ground Floor
167/3, Avadi poonamallee Highway, Vivekananda Nagar, Avadi, Chennai-600054
Chennai
TAMIL NADU |
9940495133
sankaranramesh39@gmail.com |
| Dr Shanmugasundaram Somasundaram |
Billroth Hospital |
Consultation Room Number 2
Mezzanine Floor,
Department of Cardiology,
Billroth Hospitals
43, Lakshmi Talkies Road, Shenoy Nagar, Chennai-600030
Chennai
TAMIL NADU |
9840077173
drsss1952@gmail.com |
| Dr J V Balasubramaniam |
Mina Heart Care |
Consultation Room Number 2,
Department of Cardiology,
Mina Heart Care,
22/12, GST Road, Guindy, Chennai-600032
Chennai
TAMIL NADU |
9962193999
drjvbala@gmail.com |
| Dr S N Narasingan |
SNN Clinic |
Room Number 1,
Department of Medicine,
SNN Clinic,
Old No. 38, New No. 12, New Thandavaraya st, Chennai-600021
Chennai
TAMIL NADU |
9789088692
drsnn.sc@gmail.com |
| Dr Murugarajan |
Sri Kannan Heart Care Centre |
Consultation Room No 1,
Department of Cardiology,
Sri Kannan Heart Care Centre
378, shop no.12, Annai Sivagami Complex, Theradi, Thiruvottriyur, Chennai-600019
Chennai
TAMIL NADU |
7824838117
murugarajanacademics@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Billroth Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amlodipine |
Amlodipine is an approved medication for essential hypertension and is available widely
Dose - start with 5 mg once a day and may increase to 10 mg after four weeks at the discretion of the investigator.
Duration - 12 weeks - is the duration of the study - beyond which medication may be continued by the investigator. |
| Comparator Agent |
Azelnidipine |
Azelnidipine is an approved medication for essential hypertension and is available widely
Dose: Azelnidipine 8 mg once a day.After 4 weeks the dose may be increased to 16 mg at the discretion of the investigator
Duration - 12 weeks
After 12 weeks the medication may be continued by the investigator. |
| Comparator Agent |
Cilnidipine |
Cilnidipine is an approved medication for essential hypertension and is available widely.
Dose 10 mg once a day for four weeks after which the dose may be increased to 20 mg once a day at the discretion of the investigator.
Duration - 12 weeks
The drug can be continued after 12 weeks by the investigator. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Known cases of Essential hypertension ie. ≥ 140/90 mm Hg as Office based recording that are naïve to beta-blocker, and CCB OR
Known cases of Essential hypertension ie. ≥ 140/90 mm Hg as Office based recording along with either T2DM, LVD and/or CKD that are naïve to beta-blocker, and CCB |
|
| ExclusionCriteria |
| Details |
known allergy to any of the Calcium channel blockers, history of active thyroid disease, CKD stage 3 or more, eGFR less than 30 ml/min/sq.m, Office BP more than 180/110 mm Hg, Secondary hypertension, type 1 diabetes mellitus, active liver disease, pregnant women, women planning pregnancy or lactating mother, person working in night shift, more than moderate valvular heart disease, pericardial disease, irregular rhythm like atrial fibrillation, unstable heart disease or heart failure. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Awake, 24 hour and Asleep Blood Pressure (SBP/DBP) between baseline and 8 weeks for the three arms using ABPM
Change in office based Blood Pressure (SBP/DBP) between baseline and 4th, 8th week and 12th week for all the three arms
|
8 weeks for the three arms using ABPM
Change in office based Blood Pressure (SBP/DBP) between baseline and 4th, 8th week and 12th week for all the three arms
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in dipping pattern between groups |
8 weeks |
| Proportions of patients achieving awake BP control of 135/85 mm Hg by ambulatory BP |
8 weeks |
| proportions of patients achieving treatment induced adverse effects |
12 weeks |
| study the change in heart rate by ambulatory BP in the three groups |
8 weeks |
| Changes in left ventricular (LV) mass index, LV Hypertrophy, LV global longitudinal strain, left atrial strain |
12 weeks |
| changes in microalbuminuria/ albumin creatinine ratio between the three groups |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
04/09/2024 |
| 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="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Calcium channel blockers are the most commonly used antihypertensive agents. The three approved agents in use commonly are amlodipine, Cilnidipine and Azelnidipine. There is no head to head multicenter comparative study of these agentsThis is a parallel arm open labelled observational multicenter study of mild to moderate hypertension. Both newly diagnosed and known cases of hypertension are included.
The objective is to compare primarily the BP lowering quantified by Ambulatory Blood Pressure Monitoring response of these three aforementioned drugs over a period of 8 weeks(+/-one week) Apart from previous use of these drugs, important confounders like irregular pulse, night shift have been excluded.
Secondary outcomes are change in urinary albumin creatinine ratio over three months, change in the dipping pattern and changes in LA strain in a subgroup of patients with left ventricular hypertrophy. Adverse outcomes to drugs are also noted.
The expected conclusion will show the comparative efficacy and safety of these three calcium channel blockers in Indian patients.
|