| CTRI Number |
CTRI/2019/09/021112 [Registered on: 06/09/2019] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
India Heart Study – The study is to evaluate the outcome of the high blood pressure in long term in treatment naive patient. |
|
Scientific Title of Study
|
India Heart Study – The Ongoing Outcomes (IHS TOO) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ERIS/19/OP01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Upendra Kaul |
| Designation |
Chairman and Dean Academics and Research |
| Affiliation |
Batra Heart Center |
| Address |
Batra Heart Center, Batra hospital & Medical Research Centre. Department of Cardiology, 1, Tughlakabad Institutional Area, MehrauliBadarpur Road, New Delhi
New Delhi
DELHI
110062
India |
| Phone |
919811150518 |
| Fax |
|
| Email |
Upendra.kaul@batrahospitaldelhi.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Upendra Kaul |
| Designation |
Chairman and Dean Academics and Research |
| Affiliation |
Batra hospital & Medical Research Centre |
| Address |
Batra Heart Center, Batra hospital & Medical Research Centre. Tughlakabad Institutional Area, MehrauliBadarpur Road, New Delhi
New Delhi
DELHI
110062
India |
| Phone |
919811150518 |
| Fax |
|
| Email |
Upendra.kaul@batrahospitaldelhi.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Viraj Suvarna |
| Designation |
President – Medical |
| Affiliation |
Eris Lifescience Ltd. |
| Address |
Eris Lifescience Ltd. Address: Medical Affair, Corporate Office, 8th Floor, Commerce House IV, Prahladnagar, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
9820006317 |
| Fax |
|
| Email |
viraj.suvarna@erislifesciences.com |
|
|
Source of Monetary or Material Support
|
| Eris Lifescience Ltd, Corporate Office, 8th Floor, Commerce House IV, Prahladnagar, Ahmedabad – 380015 Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Eris Lifescience Ltd |
| Address |
Corporate Office, 8th Floor, Commerce House IV, Prahladnagar, Ahmedabad – 380015 Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Heart care Foundation of India National NGO |
Head Office, E-219 Greater Kailash I
New Delhi – 110048 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Upendra Kaul |
Batra hospital & Medical Research Centre |
Department of Cardiology, 1, Tughlakabad Institutional Area, MehrauliBadarpur Road, New Delhi 110062
New Delhi
DELHI |
919811150518
Upendra.kaul@batrahospitaldelhi.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific research and ethic review committee (SRERC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Office systolic blood pressure between 100 and 180 mmHg and diastolic blood pressure between 60 and 110 mmHg |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects aged 18 years and older without a history of hypertension
2. Office systolic blood pressure between 100 and 180 mmHg and diastolic blood pressure between 60 and 110 mmHg |
|
| ExclusionCriteria |
| Details |
1. Subjects who are unable or unwilling to take self-measurements of blood pressure at home
2. Subjects who do not sign informed consent
3. Office Blood pressure higher than 180 and 110 mmHg for systolic and diastolic blood pressure, respectively
4. Patients with secondary Hypertension
5. Patients already on Anti-hypertensive medication |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of the study is long term follow up of the natural history of the subjects enrolled for a period of 5 years. |
5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To have better insights on how many normotensive or white coat hypertensive patients turned hypertensive over a course of time and document their natural history.
Record any hospitalizations during follow up for HT-related problems – Time period of Diagnosis (Stroke, ACS, Renal failure etc.) |
5 years |
|
|
Target Sample Size
|
Total Sample Size="8000"
Sample Size from India="8000"
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)
|
21/10/2019 |
| 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="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
High blood pressure (BP) is ranked as the
third most important risk factor for increased burden of disease in south Asia
(2010). Hypertension (HTN) exerts a substantial public health burden on
cardiovascular health status and healthcare systems in India. HTN is directly
responsible for 57% of all stroke deaths and 24% of all coronary heart disease
(CHD) deaths in India. Hypertension is a major cardiovascular risk with an
estimated prevalence of 27% of the adult Indian population. However, both
diagnosis and treatment of high blood pressure highly depends on method of
blood pressure measurement.
The present study proposal has an observational
prospective long-term follow up design. It aims at investigating the difference
between standardized office and self-blood pressure measurement and related
consequences for diagnosis of hypertension in Indian primary care practice. In
the long-term this study aims at providing more insight into subject’s blood
pressure profile and other subject characteristics in relation to long-term
cardiovascular risk. |