| CTRI Number |
CTRI/2024/06/068253 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Echocardiographic study of relaxation of the heart |
|
Scientific Title of Study
|
Hypertension with Left Ventricular Hypertrophy and Co-Relation with Global Longitudinal Strain of Left Ventricle, Left Atrial Strain and LAVI |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D.Prabhakar |
| Designation |
Cardiologist |
| Affiliation |
Ashwin Clinic |
| Address |
Consultation Room No1
AC-Block 38
Fourth Street
Annanagar
Chennai
TAMIL NADU
600040
India |
| Phone |
9884012727 |
| Fax |
|
| Email |
acertcardio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
D Prabhakar |
| Designation |
Cardiologist |
| Affiliation |
Ashwin Clinic |
| Address |
Consultation Room No 1
ACBlock38
FourthStreet
Annanagar
Chennai
TAMIL NADU
600040
India |
| Phone |
9884012727 |
| Fax |
|
| Email |
acertcardio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
D.Prabhakar |
| Designation |
Cardiologist |
| Affiliation |
Ashwin Clinic |
| Address |
Consultation Room No 1
AC Block 38
FourthStreet
Annanagar
Chennai
TAMIL NADU
600040
India |
| Phone |
9884012727 |
| Fax |
|
| Email |
acertcardio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Associates of Cardiology Education and Research in Tamilnadu (ACERT)- group of Cardiologists. Associatesof Cardiology Education and Research,
AG Block 25, Fourth Avenue,
Annanagar, Chennai, 600 040. |
|
|
Primary Sponsor
|
| Name |
ACERT Associates for Cardiology Education and Research in Tamilnadu |
| Address |
AG-25, 4th Avenue, anna Nagar, Chennai-600040 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Asha Mahilmaran |
A.M.Cariopulmonary clinic |
88, Thandavarayan Mudali Street, Washermanpet, Chennai - 600021
Chennai
TAMIL NADU |
9841010281
drashamahil@gmail.com |
| D Prabhakar |
Ashwin Clinic |
AC Block 38
Fourth Street
Annanagar
Chennai
TAMIL NADU |
9884012727
prabhud19@gmail.com |
| Shanmugasundaram Somasundaram |
Billroth Hospitals |
43, Lakshmi Talkies Road, Shenoy Nagar, Chennai - 600030
Chennai
TAMIL NADU |
9840077173
drsss1952@gmail.com |
| Murugarajan |
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= 4 |
| Name of Committee |
Approval Status |
| Billroth Hospitals |
Approved |
| Billroth Hospitals |
Approved |
| Billroth Hospitals |
Approved |
| Billroth Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I119||Hypertensive heart disease withoutheart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Not applicable |
| Comparator Agent |
Nil |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Systemic Hypertension
Echocardiography with strain imaging of Left ventricle and left atrium
1/3 - 1/2 Females |
|
| ExclusionCriteria |
| Details |
CKD,CAD,Heart Failure
Anemia,rhythm disorder, significant valvular heart disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Descriptive data and correlation between the presence of hypertension, duration of hypertension, single point BP control
LV relaxation parameters with or without LVH by echocardiography |
Baseline single point study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the diabetic subset without diabetes |
Nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
10/06/2024 |
| 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="6"
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
|
Echocardiography correlated with - LVEF, LVH, LV global longitudinal strain - automated and more precise, LA reservoir strain - most accurate measure of HFpEF, LA Volume Index
Expected Conclusion: (1) Descriptive data and correlation between the presence of hypertension, duration of hypertension, single point of BP. (2) LV relaxation parameters with or without LVH by echocardiography |