| CTRI Number |
CTRI/2025/03/083617 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Association between Myocardial deformation and QoL among patients undergoing valve replacement |
|
Scientific Title of Study
|
ASSESSMENT OF TEMPORAL CHANGES IN MYOCARDIAL DEFORMATION
ANALYSIS AND QUALITY OF LIFE AMONG PATIENTS UNDERGOING
VALVE REPLACEMENT
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chaithra Nayak |
| Designation |
Assistant Professor |
| Affiliation |
Department of Cardiology, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Karnataka, Manipal, 576104, India |
| Address |
Department of Cardiology, KMC Hospital, Kasturba Medical College, MAHE, Mangalore, Karnataka, India
Department of Cardiology, KMC Hospital, Kasturba Medical College, MAHE, Mangalore, Karnataka, India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7204178031 |
| Fax |
|
| Email |
chaithra.nayak@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Chaithra Nayak |
| Designation |
Assistant Professor |
| Affiliation |
Department of Cardiology, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Karnataka, Manipal, 576104, India |
| Address |
Department of Cardiology, KMC Hospital, Ambedkar Circle, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7204178031 |
| Fax |
|
| Email |
chaithra.nayak@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Chaithra Nayak |
| Designation |
Assistant Professor |
| Affiliation |
Department of Cardiology, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Karnataka, Manipal, 576104, India |
| Address |
Department of Cardiology, Kasturba Medical College, Mangalore.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7204178031 |
| Fax |
|
| Email |
chaithra.nayak@manipal.edu |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF CARDIOLOGY, KMC Hospital, Ambedkar circle Mangalore, 575001, Karnataka India |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [Not applicable ] |
|
|
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 Chaithra Nayak |
KMC Hospital |
Department of Cardiology, OPD, 2nd floor
Dakshina Kannada
KARNATAKA |
7204178031
chaithra.nayak@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged above 18 year identified with isolated, severe native valve stenosis/regurgitation with or without concomitant moderate stenosis/regurgitant lesion with or without symptoms, preserved or reduced LVEF (LVEF more or less than 50%) planned for valve replacement as per ACC/AHA 2020 guidelines |
|
| ExclusionCriteria |
| Details |
1.Patients with sub valvar / supravalvular lesions
2.Patients with valve prosthesis undergoing re-do surgery.
3.Patients implanted with permanent pacemaker.
4.Co-existing pulmonary artery disease of non-cardiac origin.
5.Patients diagnosed with coronary artery disease and concomitant valve disease scheduled for bypass surgery and valve replacement.
6.Patients having poor acoustic image quality
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
•Myocardial deformation parameters: Global longitudinal strain (%), 3D auto RV function, 3D chamber volumes
•Quality of life (WHO BREF score)
Functional Activity assessment (DASI score) |
3 time points
At baseline, pre discharge and 6 month follow up
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
MACE
Non Cardiovascular Mortality
Surgical outcomes Echocardiographic & deformation parameters |
The outcomes will be assessed at 3 time points
Baseline
pre-discharge & at 6 months |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
10/04/2025 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
1. Application of deformation analysis in single and combined valve lesions may provide better insights into attributable factors and help predict functional class and Quality of Life. Integrating deformation analysis aids in identifying subclinical myocardial dysfunction that determines the clinical outcome after valve replacement. Since RV dysfunction is commonly observed in valvular heart disease, additional assessment of RV function before valve intervention may contribute intended surgical approach. Hence, preservation of right heart geometry and its function can impact long-term outcomes in patients undergoing valve replacement.
|