| CTRI Number |
CTRI/2025/12/099277 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observing right side heart function in adults with left valvular heart disease undergoing heart surgery |
|
Scientific Title of Study
|
Pulmonary pulse transit time in predicting right ventricular-pulmonary artery
uncoupling in adults with left valvular heart disease 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 |
devishree das |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department of Anaesthesiology, AIIMS, Bhubaneswar, Sijua, Patrapada, Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
8895299296 |
| Fax |
|
| Email |
devishreedas111@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
devishree das |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department of Anaesthesiology, AIIMS, Bhubaneswar, Sijua, Patrapada, Bhubaneswar
ORISSA 751019 India |
| Phone |
8895299296 |
| Fax |
|
| Email |
devishreedas111@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
devishree das |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department of Anaesthesiology, AIIMS, Bhubaneswar, Sijua, Patrapada, Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
8895299296 |
| Fax |
|
| Email |
devishreedas111@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, Bhubaneswar |
| Address |
Sijua, Patrapada, Bhubaneswar, Khorda, Orissa, 751019 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Devishree Das |
AIIMS, Bhubaneswar |
Department of Anaesthesiology, AIIMS, Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Khorda Khordha ORISSA |
8895299296
devishreedas111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committeeee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I051||Rheumatic mitral insufficiency, (2) ICD-10 Condition: I050||Rheumatic mitral stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
adult patients with left valvular heart disease and moderate to severe TR undergoing elective cardiac surgery will be included |
|
| ExclusionCriteria |
| Details |
Patients with underlying structural heart disease such as atrial septal defects, congenital heart disease, and insufficient transesophageal echocardiography (TEE) image quality will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| correlation of pPTT with a validated predictive parameter of RV-PA uncoupling |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| correlation of pPTT with other parameters of RV-PA uncoupling such as TAPSE/PASP, S’/RVSP, RV-FAC/RVSP, RV-EF/PASP, RV LS/RVSP |
before surgery |
| Difference in pPTT between coupled and uncoupled RVs |
before surgery |
| Cutoff values of pPTT and normalize pPTT that predicts RV-PA uncoupling |
before surgery |
| Determine the correlation of pPTT with normalize pPTT |
before surgery |
| Incidence of in hospital POAF and cutoff value of pPTT for POAF |
before surgery |
|
|
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)
|
30/12/2025 |
| 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 Applicable |
| 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
|
Pulmonary pulse transit time (pPTT) is a novel non-invasive echocardiographic measure to assess pulmonary arterial hemodynamic. It is the time needed for the pulse wave to propagate from the right ventricular outflow tract (RVOT) to the left atrium. Pulse wave velocity (PWV) defined as the velocity of pressure waves traveling through the arterial system, correlates inversely with arterial compliance in the circulation. With decreasing compliance, pulse wave velocity increases, and the time taken by the pressure wave to travel between 2 vascular points shortens. pPTT has been identified as clinically important surrogates for assessing arterial compliance in the pulmonary circulation but there is technical difficulties in measuring pulse wave velocity in the pulmonary circulation. Recently, Wibmer et al. defined pPTT, as the delay between onset of ventricular electrical activity (on electrocardiogram) and the arrival of the pulse wave in the pulmonary vein (as determined by Doppler echocardiography of the pulmonary vein), and found to be reduced in patients with pulmonary hypertension. Wibmer et al. postulated that pPTT was shortened because of decreased pulmonary artery(PA) compliance and increased pulse wave velocity, and they proposed pPTT as a potential index of PA compliance. pPTT has been studied in chronic obstructive pulmonary disease and connective tissue disorder induce pulmonary hypertension i.e precapillary hypertension. However, Gurbuz et al, demonstrated prolonged pPTT in patients with significant mitral stenosis i.e postcapillary hypertension. They found a positive correlation between pPTT with pulmonary artery systolic pressure(PASP) and inverse correlation with tricuspid annular plane systolic excursion(TAPSE) which were the predictors of increased right ventricle(RV) afterload. Also, pPTT directly related to left atrial volume index(LAVi) which is a predictor of postoperative atrial fibrillation(POAF). Both RV-PV coupling and POAF were not discussed in this study. In addition, no other study has explored the usefulness of pPTT in predicting the RV-PA uncoupling and POAF which are commonly seen in patients with left heart disease. Therefore, the primary aim of the study is to further characterisation of pPTT in patients with left heart disease and to evaluate whether it predicts RV-PA uncoupling and POAF in this cohort of patients. |