| CTRI Number |
CTRI/2017/07/009144 [Registered on: 27/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
21/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
observational |
| Study Design |
Other |
|
Public Title of Study
|
To assess association of genetic markers in the renalase gene with hypertension. |
|
Scientific Title of Study
|
Association of single nucleotide polymorphism in the Renalase genes with hypertension in an Indian population.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijayakumar |
| Designation |
Sr.Consultant cardiology |
| Affiliation |
The Madras Medical Mission Hospital |
| Address |
The Madras Medical Mission Hospital,Institute of Cardiovascular diseases, Room no.15,
No.4A, Dr.J.J.Nagar, Mogappair,
Chennai
Chennai
TAMIL NADU
-600037
India |
| Phone |
044-26565974 |
| Fax |
044-26565974 |
| Email |
drkumarvijay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayakumar |
| Designation |
Sr.Consultant cardiology |
| Affiliation |
The Madras Medical Mission Hospital |
| Address |
The Madras Medical Mission Hospital,Institute of Cardiovascular diseases, Room no.15,
No.4A, Dr.J.J.Nagar, Mogappair,
Chennai
Chennai
TAMIL NADU
-600037
India |
| Phone |
044-26565974 |
| Fax |
044-26565974 |
| Email |
drkumarvijay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayakumar |
| Designation |
Sr.Consultant cardiology |
| Affiliation |
The Madras Medical Mission Hospital |
| Address |
The Madras Medical Mission Hospital,Institute of cardiovascular Diseases, Room.No.15,
No.4A, Dr.J.J.Nagar, Mogappair,
Chennai
Chennai
TAMIL NADU
600037
India |
| Phone |
044-26565974 |
| Fax |
044-26565974 |
| Email |
drkumarvijay@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
The Madras Medical Mission Hospital |
| Address |
The Madras Medical Mission Hospital,
No.4A, Dr.J.J.Nagar, Mogappair,
Chennai |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Vijayakumar |
The Madras Medical Mission Hospital |
Room No.15,Institute of Cardiovascular Diseases,The Madras Medical Mission Hospital,
No.4A, Dr.J.J.Nagar, Mogappair,
Chennai
Chennai
TAMIL NADU |
044-26565974
044-26565974
drkumarvijay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Systolic BP greater or equal to 140 mm HG or diastolic BP of less than or equal to 90 mm Hg or being treated with anti-hypertensive drugs., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Systolic BP greater or equal to 140 mm HG or diastolic BP of less than or equal to 90 mm Hg or being treated with anti-hypertensive drugs. |
|
| ExclusionCriteria |
| Details |
Cancer or Hepatitis positive or HIV positive |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the potential association of canditate SNPs in the renalase gene in hypertensive patients. |
To investigate the potential association of canditate SNPs in the renalase gene in hypertensive patients. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To predict early diagnosis of hypertension |
To predict early diagnosis of hypertension |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
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)
|
01/08/2015 |
| 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) |
Open to Recruitment |
|
Publication Details
|
None yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
5 ml of Blood samples are collected from the hypertensive patients for few biochemical tests and regular physiological parameters such as blood pressure, heart rate, height, weight will be checked .The association analysis will be done to see the amount of renalase gene Present. |