| CTRI Number |
CTRI/2023/05/052428 [Registered on: 09/05/2023] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Heart function using new echocardiographic indices between patients with genetically thickened cardiac muscle condition and severe kidney disease patients. |
|
Scientific Title of Study
|
COMPARISON OF MYOCARDIAL DEFORMATION IMAGING IN PATIENTS BETWEEN HYPERTROPHIC CARDIOMYOPATHY AND CHRONIC KIDNEY DISEASE ASSOCIATED WITH LEFT VENTRICULAR HYPERTROPHY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SREESHA P |
| Designation |
STUDENT |
| Affiliation |
MAHE |
| Address |
Room No.212,IInd floor Department of Cardiovascular Technology
MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7560865197 |
| Fax |
|
| Email |
sreesha.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
SRIDEVI PRABHU |
| Designation |
ASSISTANT PROFESSOR-SELECTION GRADE |
| Affiliation |
MAHE |
| Address |
Room No.212,IInd floor Department of Cardiovascular Technology
MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8867902764 |
| Fax |
|
| Email |
sridevi.santhosh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
SRIDEVI PRABHU |
| Designation |
ASSISTANT PROFESSOR-SELECTION GRADE |
| Affiliation |
MAHE |
| Address |
Room No.212,IInd floor Department of Cardiovascular Technology
MAHE Manipal
KARNATAKA
576104
India |
| Phone |
8867902764 |
| Fax |
|
| Email |
sridevi.santhosh@manipal.edu |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF CARDIOLOGY, KASTURBA MEDICAL COLLEGE AND HOSPITAL, 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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SREESHA P |
KASTURBA HOSPITAL |
Department of Cardiology, Room No34, 3rd Floor, OPD Block, Manipal
Udupi
KARNATAKA |
7560865197
sreesha.mchpmpl2022@learner.manipal.edu |
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I422||Other hypertrophic cardiomyopathy, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with HCM and hypertrophy secondary to renal failure-CKD (stage III, IV and V)
CKD patients with IVS diastolic thickness of 1.5cm
|
|
| ExclusionCriteria |
| Details |
LVH secondary to any other reasons except for CKD
Dilated cardiomyopathy
Acute decompensated Heart Failure
Poor echo window
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the Global longitudinal strain and systolic and diastolic strain rate patterns in patients with HCM and LVH secondary to CKD |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2023 |
| Date of Study Completion (India) |
15/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/03/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
Speckle Tracking Echocardiography is a useful technique in distinguishing pathologic and physiological hypertrophy by changes in strain rate pattern. There is no data comparing the myocardial deformation patterns in Hypertrophic Cardiomyopathy and secondary left ventricular hypertrophy in Chronic Kidney Disease. Therefore evaluation of Global longitudinal strain and strain rates in early stage of disease can help in prognosis and modification of the treatment.
PRIMARY OUTCOME: To evaluate and compare Global longitudinal strain and systolic and diastolic strain rate patterns in patients with HCM and LVH secondary to CKD
|