| CTRI Number |
CTRI/2020/12/029750 [Registered on: 11/12/2020] Trial Registered Prospectively |
| Last Modified On: |
07/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship and differences between Central Aortic and Peripheral Blood Pressure measurement performed with the same device. |
|
Scientific Title of Study
|
Relationship and differences between Central Aortic and Peripheral Blood Pressure measurement performed with same device |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Upendra Kaul |
| Designation |
Principal Investigator |
| Affiliation |
Batra Hospital & Medical Research Centre |
| Address |
1, Tughlakabad Institutional Area, Mehrauli Badarpur Road, New Delhi-110 062
1, Tughlakabad Institutional Area, Mehrauli Badarpur Road, New Delhi-110 062
New Delhi
DELHI
110062
India |
| Phone |
9811150518 |
| Fax |
|
| Email |
kaul.upendra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh Goswami |
| Designation |
Medical Specialist- Medical Affairs and Clinical Research |
| Affiliation |
Eris Lifesciences Ltd. |
| Address |
Department, 8th floor, commerce house IV, besides shell petrol pump, near Prahladnagar garden, 100 ft. road, satellite, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
8291411412 |
| Fax |
|
| Email |
nilesh.goswami@erislifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilesh Goswami |
| Designation |
Medical Specialist- Medical Affairs and Clinical Research |
| Affiliation |
Eris Lifesciences Ltd. |
| Address |
Department, 8th floor, commerce house IV, besides shell petrol pump, near Prahladnagar garden, 100 ft. road, satellite, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
8291411412 |
| Fax |
|
| Email |
nilesh.goswami@erislifesciences.com |
|
|
Source of Monetary or Material Support
|
| Eris Lifesciences Ltd
Department, 8th floor, commerce house IV, besides shell petrol pump, near Prahladnagar garden, 100 ft. road, satellite, Ahmedabad- 380015,GUJARAT, India |
|
|
Primary Sponsor
|
| Name |
Eris Lifesciences Ltd |
| Address |
8th floor, commerce house IV, besides shell petrol pump, near Prahladnagar garden, 100 ft. road, satellite, Ahmadabad |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abraham Oomman |
Apollo Hospital Enterprise Limited |
No.21, Greams Lane, Off Greams road, Chennai - 600006, Tamil Nadu
Chennai
TAMIL NADU |
9841174578
drabrahamoomman@gmail.com |
| Prof Dr Upendra Kaul |
Batra Hospital & Medical Research Centre |
1, Tughlakabad Institutional Area, Mehrauli Badarpur Road, New Delhi-110 062
New Delhi
DELHI |
9811150518
kaul.upendra@gmail.com |
| Prof Dr Gurpreet Singh Wander |
HERO DMC Heart Institute, Dayanand Medical College & Hospital |
Civil Lines, Tagore nagar, Ludhiana, Punjab 141001
Ludhiana
PUNJAB |
9815545316
drgswander@yahoo.com |
| Dr Prof JC Mohan |
Jaipur Golden Hospital |
Street Number 2, near Institutional Area, Institutional Area, Sector 3, Rohini, Delhi, 110085
North West
DELHI |
9811061392
a51hauzkhas@gmail.com |
| Dr Thomas Alexander |
Kovai Medical Center and Hospital, |
99, Avanashi Road, Coimbatore - 641014
Coimbatore
TAMIL NADU |
9791907685
tomalex41@gmail.com |
| Dr PB Jayagopal |
Laxmi Hospital |
No. 17/551 chittur road, Palakkad, Kerala-678013
Palakkad
KERALA |
9847023777
jaigopallakshmi@gmail.com |
| Dr JPS Sawhney |
Sir Ganga Ram Hospital |
Sarhadi Gandhi Marg, near Bal Bharati Public School, Old Rajinder Nagar, Rajinder Nagar, New Delhi, Delhi 110060
New Delhi
DELHI |
9810059773
jpssawhney@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics committee, Sir Ganga Ram Hospital |
Approved |
| Institutional Ethics Committee, Dayanand Medical College & Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, King Georges Medical University |
Submittted/Under Review |
| Scientific research and ethic review committee (SRERC), Batra Hospital & Medical Research Centre |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Outpatients with hypertension (BP greater than 140/90 mm Hg or any level of blood pressure in persons on antihypertensive medications)
2. Newly Diagnosed Hypertensive Patients
3. Normotensive patients on antihypertensive
4. Hypertensive subjects with a family history of premature coronary heart disease
5. Hypertensive patients with comorbidities (Diabetes, Dyslipidaemia, CAD, left ventricular hypertrophy, peripheral arterial disease, cerebrovascular disease, microalbuminuria or proteinuria)
|
|
| ExclusionCriteria |
| Details |
1. Subjects with evidence of recent event (MI < 1-month duration, treated angina at the time of enrolment, a cerebrovascular event in the 3 months before enrolment, heart failure, uncontrolled arrhythmias, or any clinically important haematological or biochemical abnormality on routine screening)
2. In-patients/Hospitalized patients
3. Pregnant Women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish correlation and differences between brachial blood pressure and central blood pressure so as to establish the cut-off values (threshold values) for central blood pressure based on the brachial blood pressure. |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish the correlation between CBP and BBP with organ damage (LV hypertrophy, End-stage kidney disease etc) |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200"
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)
|
17/12/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Accumulating
evidence indicates that central blood pressure (CBP) is a better cardiovascular
risk predictor than brachial blood pressure (BBP). Although more additional
benefits of CBP based treatment above usual hypertension treatment are to be
demonstrated, the demand for implementing CBP assessment in general clinical
practice is increasing. For this, the measurement procedure must be non-invasive,
easy to perform, and cost- and time-efficient. Therefore, oscillometric devices
with the possibility to assess CBP seem the best option |