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CTRI Number  CTRI/2022/10/046628 [Registered on: 19/10/2022] Trial Registered Prospectively
Last Modified On: 04/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Single Arm Study 
Public Title of Study   Heart scanning in patients with longstanding kidney injury and hypertension 
Scientific Title of Study   Comparison of left atrial strain and left ventricular torsion between persons with chronic kidney disease and hypertension.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sameeksha S Shetty 
Designation  MSc Echocardiography 
Affiliation  Manipal College of Health Professions  
Address  2nd floor, Department of Cardiovascular Technology, MCHP, MAHE, Manipal
Room no 34, 3rd floor OPD block, Department of Cardiology, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9632285017  
Fax    
Email  shettysameeksha156@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tom Devasia 
Designation  MBBS, MD, DM (Cardiology), Professor and Head, Department of Cardiology, KMC, Manipal-576104 
Affiliation  KMC, Manipal 
Address  Room no 36, 3rd floor OPD block, Department of Cardiology, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448158508  
Fax    
Email  tomdevasia@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tom Devasia 
Designation  MBBS, MD, DM (Cardiology), Professor and Head, Department of Cardiology, KMC, Manipal-576104 
Affiliation  KMC, Manipal 
Address  Room no 36, 3rd floor OPD block, Department of Cardiology, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448158508  
Fax    
Email  tomdevasia@hotmail.com  
 
Source of Monetary or Material Support  
Department of Cardiology, Kasturba Medical College and Hospital, MAHE, Manipal  
 
Primary Sponsor  
Name  Department of Cardiology 
Address  Kasturba Medical College and Hospital, MAHE, Manipal 
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 
Sameeksha S Shetty  Kasturba Hospital   Room No 34,3rd floor, OPD block, Kasturba Hospital, Manipal
Udupi
KARNATAKA 		 9632285017

shettysameeksha156@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Hospital, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Routine evaluation of healthy individuals 
Patients  (1) ICD-10 Condition: I129||Hypertensive chronic kidney disease with stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusion criteria : Cases:
1. Patients ( aged ≥ 18 years) with 3rd ,4th and 5th stages of chronic kidney disease.
2.Hypertensive patients who undergone Echocardiography showing with or without Left ventricular hypertrophy (LVH).

Controls:
Healthy controls who come for routine cardiac evaluation are referred for echocardiography
 
 
ExclusionCriteria 
Details  1.Arrhythmias
2.Valvular Heart Disease
3.Coronary Artery Disease
4.Congenital Heart Disease
5.Patients with poor echo window
6.Past history of stroke

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare left atrial strain and left ventricular torsion between chronic kidney disease and hypertensive patients in comparison with healthy controls.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the ventricular systolic and diastolic function and other demographic features in CKD, hypertensive and healthy individuals.  1 year 
 
Target Sample Size   Total Sample Size="141"
Sample Size from India="141" 
Final Enrollment numbers achieved (Total)= "141"
Final Enrollment numbers achieved (India)="141" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/11/2022 
Date of Study Completion (India) 14/04/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 14/04/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is mainly done to detect subclinical myocardial deformation in CKD, and hypertensive patients in comparison with healthy individuals.

Primary objectives:

To compare left atrial strain and left ventricular torsion between chronic kidney disease and hypertensive patients in comparison with healthy controls

Secondary objectives:

·       To compare myocardial deformation imaging parameters between CKD and HTN patients with and without left ventricular hypertrophy.

·    To compare diastolic function by transmitral pulsed wave doppler, mitral annular tissue Doppler and Pulmonary venous Doppler flow patterns between CKD patients, hypertensive patients and healthy controls.


 
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