| CTRI Number |
CTRI/2024/06/068983 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of correlation between Left Ventricular Hypertrophy in young Hypertensives across various Body Mass Index categories |
|
Scientific Title of Study
|
Study of assessment of Left Ventricular Hypertrophy in 18 to 40 years old Hypertensive patients across various BMI categories |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Venkatesh Reddy B |
| Designation |
Post Graduate |
| Affiliation |
KMC, Manipal |
| Address |
Department of General Medicine, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7975355624 |
| Fax |
|
| Email |
venkatesh.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasudeva Acharya |
| Designation |
Professor, Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal-576104, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
8197597008 |
| Fax |
|
| Email |
acharya.vasudev@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasudeva Acharya |
| Designation |
Professor, Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal-576104, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
8197597008 |
| Fax |
|
| Email |
acharya.vasudev@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal-576104, Udupi, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Venkatesh Reddy B |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal-576104, Udupi, Karnataka, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Venkatesh Reddy B |
Kasturba Medical College, Manipal |
Department of General Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA |
7975355624
venkatesh.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee -2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: I158||Other secondary hypertension, (3) ICD-10 Condition: I150||Renovascular hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.18 to 40 years old hypertensive patients
2.Diagnosed hypertension in childhood on antihypertensive medications
3.Both OP and IP hypertensive patients who are undergoing cardiac evaluation with 2D echo and ECG
4.Participants should be asian Indian |
|
| ExclusionCriteria |
| Details |
1.Pregnant females
2.Patients who have undergone weight reduction surgery or
on weight reducing drugs
3.Patients who have been diagnosed as primary or secondary cardiac tumor that invade left ventricular chamber
4.Patients with prosthetic carbon valve and metallic valve in mitral position |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation Between LVH in 18 to 40 years old Hypertensives and BMI over a period of 2 years |
Correlation Between LVH in 18 to 40 years old Hypertensives and BMI over a period of 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Type of LVH is correlated with Categories of BMI |
2 Years |
|
|
Target Sample Size
|
Total Sample Size="139"
Sample Size from India="139"
Final Enrollment numbers achieved (Total)= "167"
Final Enrollment numbers achieved (India)="167" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
14/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
14/03/2026 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This thesis focuses on the study of prevalence, degree & type of Left Ventricular Hypertrophy (LVH) in a specific demographic 18 to 40-years old individuals across diverse BMI categories • This age group represents a pivotal stage in life where lifestyle patterns are often established, and early detection of cardiac abnormalities can inform timely interventions. • The inclusion of various BMI categories is motivated by the escalating global obesity epidemic. • The study aims to provide insights into the relationship between BMI and LVH, contributing valuable knowledge that can be used to prevent the cardiovascular risks faced by 18 to 40 aged hypertensive adults. |