| CTRI Number |
CTRI/2018/01/011306 [Registered on: 12/01/2018] Trial Registered Prospectively |
| Last Modified On: |
11/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of blood pressure lowering medicines on function of blood vessels in elderly patients with high blood pressure |
|
Scientific Title of Study
|
An observational study of the effect of first line anti-hypertensive drugs on endothelial function in newly diagnosed elderly hypertensive patients |
| Trial Acronym |
HTNEND trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PROF I S Gambhir |
| Designation |
Professor |
| Affiliation |
IMS BHU |
| Address |
Department Of Medicine
Institute Of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415255998 |
| Fax |
|
| Email |
iac2k10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF I S Gambhir |
| Designation |
Professor |
| Affiliation |
IMS BHU |
| Address |
Department Of Medicine
Institute Of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415255998 |
| Fax |
|
| Email |
iac2k10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashis Kumar Choudhury |
| Designation |
Junior Resident |
| Affiliation |
IMS BHU |
| Address |
Department Of Medicine
Institute Of Medical Sciences
Banaras Hindu University
Dr Ashis Kumar Choudhury,
Room No.69,Sushruta Hostel
Trauma Center
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8948460937 |
| Fax |
|
| Email |
ashischoudhury91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute Of Medical Sciences
Banaras Hindu University, Varanasi, Uttar Pradesh, 221005 |
|
|
Primary Sponsor
|
| Name |
IMS BHU |
| Address |
Department Of Medicine
IMS BHU |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| PROF I S Gambhir |
IMS BHU |
Department of General Medicine
IMS,BHU
Varanasi
Uttar Pradesh
Varanasi
UTTAR PRADESH |
9415255998
iac2k10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee,IMS,BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hypertension, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Newly diagnosed elderly hypertensive patients
2. Who give consent for the study |
|
| ExclusionCriteria |
| Details |
1. Patients who do not give consent
2. Already diagnosed case of Hypertension i.e. on treatment
3. Past h/o Coronary artery disease
4. Past h/o Cerebrovascular accident
5. Moderate to severe renal dysfunction,i.e. with creatinine clearance <45/ml/min
6. Patient taking any anti-dyslipidemic or any antiplatelet drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in endothelial function assessed by flow mediated dilatation of brachial artery |
0 at baseline and after 1 month of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure lowering effect and safety analysis |
0 and 1 month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/01/2018 |
| 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="6"
Days="20" |
|
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)?
|
|
Brief Summary
|
Essential hypertension is one of the leading cause of endothelial dysfunction, which is a major risk factor for atherosclerosis and can lead to CAD and CVA. Endothelial function can be assessed non-invasively by flow mediated dilatation of brachial artery. There are many studies on the effect of anti-hypertensive drugs in the modification of endothelial dysfunction,but there are no such study in elderly hypertensive patients in India. The aim of the study is study is to asses the effect of anti-hypertensive drugs on endothelial function in elderly hypertensive patients.Elderly hypertensive patients will be randomised into four groups by computer generated random numbers. Baseline endothelial function will be assessed by flow mediated dilatation and each subject will be treated with either of Olmesartan,Nebivolol,Amlodipine,Chlorthalidone for a duration of one month after considering other health related outcomes. Endothelial function will be assessed again after one month by F.M.D and improvement, if any, will be noticed. |