CTRI

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CTRI Number

CTRI/2026/03/105834 [Registered on: 10/03/2026] Trial Registered Prospectively

Last Modified On:

10/03/2026

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Case Control Study

Study Design

Other

Public Title of Study

Comparison of ascending aortic strain between patients who have hypertension and healthy individuals

Scientific Title of Study

Comparison of ascending aortic strain between hypertensives and healthy controls

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Poojary Manasi Bhoja
Designation	Postgraduate student
Affiliation	Manipal College of Health Professions
Address	Department of Cardiovascular Technology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal. Udupi KARNATAKA 576104 India
Phone	8147095523
Fax
Email	manasipoojary96@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Umesh Pai
Designation	Assistant Professor(Selection Grade)
Affiliation	Manipal College of Health Professions
Address	Department of Cardiovascular Technology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal. Udupi KARNATAKA 576104 India
Phone	9449388828
Fax
Email	umesh.pai@manipal.edu

Details of Contact Person
Public Query

Name	Dr Umesh Pai
Designation	Assistant Professor(Selection Grade)
Affiliation	Manipal College of Health Professions
Address	Department of Cardiovascular Technology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal. Udupi KARNATAKA 576104 India
Phone	9449388828
Fax
Email	umesh.pai@manipal.edu

Source of Monetary or Material Support

Department of Cardiology, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Madhav Nagar, Manipal,Udupi,Karnataka,India-576104

Primary Sponsor

Name	Manipal Academy of Higher Education
Address	Manipal Academy of Higher Education, Madhav Nagar,Manipal,Udupi,Karnataka,PIN-576104
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Poojary Manasi Bhoja	Kasturba Hospital,Manipal	Echo room, Department of Cardiology,3rd floor, Kasturba Hospital, Tiger Circle Road, Madhav Nagar,Manipal,Udupi,Karnataka,PIN-576104 Udupi KARNATAKA	8147095523 manasipoojary96@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

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	Nil

Inclusion Criteria

Age From	30.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	Case group: Age-30 to 50 years, either gender, known case of hypertension with or without medication Control group: Age-30 to 50 years, either gender

ExclusionCriteria

Details

1. Coronary artery disease,
2. Congenital heart disease,
3. Cardiomyopathy,
4. Cerebrovascular disease,
5. Chronic kidney disease,
6. Significant (more than mild) primary valvular disease,
7. Poor echocardiographic window

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Aortic strain LV mass LV function	Baseline

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="189"
Sample Size from India="189"
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)

23/03/2026

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

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

The study titled Comparison of ascending aortic strain between hypertensives and healthy controls using echocardiographic imaging is a single-center prospective observational study. The study aims to compare ascending aortic strain between hypertensive patients and healthy controls. The primary objective is to compare ascending aortic strain between hypertensive patients and healthy controls. The secondary objective is to examine the correlation between aortic strain and LV mass in hypertensive patients and to find the correlation between aortic strain and LV function parameters.

Patients diagnosed with hypertension according to the 2025 AHA/ACC guidelines and healthy controls referred for an echocardiography will be screened based on inclusion and exclusion criteria. Healthy controls will include individuals who come for routine cardiac evaluation with no comorbidities. Study will be explained to the participants, and informed consent will be obtained. Demographic data will be documented from the case sheet. Echocardiographic parameters will be recorded and stored along with connected ECG. Initially, a few cases will be evaluated for inter-rater reliability between two investigators (a postgraduate student and an experienced sonographer) for echocardiographic parameters such as aortic strain, LV strain, LV mass, etc.