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CTRI Number  CTRI/2025/09/094174 [Registered on: 03/09/2025] Trial Registered Prospectively
Last Modified On: 02/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Echocardiography for predicting heart dysfunction 
Scientific Title of Study   Right atrial strain in predicting right ventricular-pulmonary artery uncoupling in adult valvular heart disease patients with pulmonary artery hypertension undergoing cardiac surgery: A prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Satyajeet Misra 
Designation  Professor and HOD 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Dept of Anaesthesia and Critical Care, All India Institute of Medical Sciences, Bhubaneswar Sijua, Patrapada, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884048  
Fax    
Email  misrasatyajeet@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Satyajeet Misra 
Designation  Professor and HOD 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Dept of Anaesthesia and Critical Care, All India Institute of Medical Sciences, Bhubaneswar Sijua, Patrapada, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884048  
Fax    
Email  misrasatyajeet@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Satyajeet Misra 
Designation  Professor and HOD 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Dept of Anaesthesia and Critical Care, All India Institute of Medical Sciences, Bhubaneswar Sijua, Patrapada, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884048  
Fax    
Email  misrasatyajeet@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Khorda, Orissa, 751019 
 
Primary Sponsor  
Name  Satyajeet Misra 
Address  Room no-409, Academic block, All India Institute of Medical Sciences Sijua, Patrapada, Bhubaneswar, Orissa, India, 751019 
Type of Sponsor  Other [Individual] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deepak Borde  Ozone Hospitals, Aurangabad  Department of Cardiac Anesthesia, Ozone Hospitals, Aurangabad
Aurangabad
MAHARASHTRA 
7350357108

deepakborde2482@gmail.com 
Dr Satyajeet Misra  All India Institute of Medical Sciences Bhubaneswar  Sijua, Patrapada, Bhubaneswar, Orissa
Khordha
ORISSA 
9438884048

misrasatyajeet@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee  Approved 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I061||Rheumatic aortic insufficiency, (2) ICD-10 Condition: I060||Rheumatic aortic stenosis, (3) ICD-10 Condition: I051||Rheumatic mitral insufficiency, (4) ICD-10 Condition: I050||Rheumatic mitral stenosis, (5) ICD-10 Condition: I052||Rheumatic mitral stenosis with insufficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adults with left sided heart disease and pulmonary artery hypertension will be included in this study. 
 
ExclusionCriteria 
Details  Adults with insufficient images will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the correlation of peak RA strain with TAPSE/PASP that predicts RV-PA uncoupling in patients with PAH.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Differences in peak RA strain values between coupled & uncoupled RVs  Baseline 
Cutoff values of peak RA strain that predicts RV-PA uncoupling.  Baseline 
Correlation of peak RA strain with other echocardiographic measures of uncoupled RVs  Baseline 
Correlation of conduit & contractile strain values with TAPSE/PASP in uncoupled ventricles.  Baseline 
Changes in RA EF in RV-PA uncoupling.  Baseline 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   15/09/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Right ventricular–pulmonary artery (RV-PA) coupling refers to the interplay between RV contractility and RV afterload. Normal RV-PA coupling is maintained only when the RV function and RV afterload, i.e., the pulmonary vascular resistance are appropriately matched. A normal RV-PA coupling leads to a more efficient energy transfer between the RV and PA, and optimizes myocardial work. RV-PA uncoupling occurs when RV contractility cannot increase to match increased RV afterload as in patients with pulmonary artery hypertension (PAH), resulting in RV dysfunction and failure. Identifying uncoupled RVs in patients with PAH may help determine which patients are at a greater risk of RV failure following cardiac surgery; thus, potentially serving as a risk-stratification marker. 

RV-PA coupling is computed as the ratio of RV end-systolic elastance (contractility index) to PA elastance (arterial load index), measured invasively with right heart catheterization. Though it has high sensitivity and accuracy, it is technically difficult to perform and has limited bedside applicability. RV-PA coupling can be also assessed non-invasively with echocardiography. Amongst the various non-invasive surrogates for RV-PA coupling, the tricuspid annular plane systolic excursion (TAPSE)/pulmonary artery systolic pressure (PASP) ratio has emerged as the best parameter that identifies uncoupled RVs. A cutoff value of TAPSE/PASP of < 0.36 mm/mm Hg predicts RV-PA uncoupling in patients with left heart disease. 

RA strain is a novel parameter that provides a measure of RV function. It includes reservoir strain (peak RA strain), which indicates atrial compliance during ventricular systole; and conduit and pump (contractile) strain during ventricular diastole It can easily be obtained by the apical 4-chamber view and is an angle as well as load independent parameter. Though RA strain has been used to predict RV dysfunction in patients with type I PAH, cardiomyopathies, atrial arrhythmias etc., its usefulness in predicting RV-PA uncoupling is yet unexplored in adult valvular heart disease patients with PAH undergoing cardiac surgery. We hypothesize that preoperative RA strain can be used to predict RV-PA uncoupling following cardiac surgery. 

 
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