| CTRI Number |
CTRI/2024/05/067073 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Non invasive detection of pulmonary artery hypertension in patients with left heart disease |
|
Scientific Title of Study
|
Identifying Pulmonary Hypertension Phenotype in Left Heart Disease Patients Undergoing Cardiac Surgery Using Echocardiographic Variables: 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 |
Dr Arshdeep Singh |
| Designation |
Senior resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of cardiac anaesthesia, 4th floor, Advanced Cardiac Center, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8447981110 |
| Fax |
|
| Email |
drarshdeep95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BanaShree Mandal |
| Designation |
Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Room number 12, Department of cardiac anaesthesia, 4th floor, Advanced Cardiac Center, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8146266102 |
| Fax |
|
| Email |
banashreemandal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arshdeep Singh |
| Designation |
Senior resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of cardiac anaesthesia, 4th floor, Advanced Cardiac Center PGIMER
Chandigarh
CHANDIGARH
160016
India |
| Phone |
8447981110 |
| Fax |
|
| Email |
drarshdeep95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate institute of medical education and research, Sector 12, Chandigarh 160012 |
|
|
Primary Sponsor
|
| Name |
Dr Arshdeep Singh |
| Address |
Department of Cardiac Anaesthesia, Advanced Cardiac Centre, Chandigarh |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr BanaShree Mandal |
Department of cardiac anaesthesia, Advanced Cardiac Center, Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arshdeep Singh |
Advanced Cardiac Center, Post graduate institute of medical education and research |
CTVS OT and CTVS ICU, 4th floor, Advanced Cardiac Center, Post graduate institute of medical education and research
Chandigarh
CHANDIGARH |
8447981110
drarshdeep95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Intramural) PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I059||Rheumatic mitral valve disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Left heart surgeries |
|
| ExclusionCriteria |
| Details |
1. Poor TTE window
2. Contraindication to TEE probe insertion |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the phenotype of pulmonary hypertension using echocardiography parameters in patients with left heart disease undergoing cardiac surgery. |
Echo will be done at baseline, before cardiopulmonary bypass, post cardiopulmonary bypass, in the ICU when inotropes are tapered and 3 months post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the effects of the pulmonary hypertension phenotype on right ventricular function in patients with left heart disease undergoing cardiac surgery.
2. To find correlation among invasive and non -invasive methods in classifying the phenotypes.
3. Quantification of pulmonary hypertension in perioperative period of cardiac surgery using invasive and non-invasive echocardiographic parameters. (upto 90 days postoperative period)
4. To assess the effects of pulmonary hypertension phenotype on post operative outcome
a. Duration of mechanical ventilation
b. Vasoactive-inotropic support
c. Duration of ICU stay
d. Morbidity and Mortality upto 90 days |
90 days |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
20/05/2024 |
| 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="0"
Months="3"
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 hypertension is a common finding in patients with cardiovascular disease. Most of these patients have left heart disease (LHD) with pulmonary hypertension secondary to an increase in left ventricular filling pressure but normal pulmonary vascular resistance (PVR). Low mean pulmonary artery (PA) pressure, low peripheral resistance, and high compliance in the central large arteries characterize the normal pulmonary circulation, and together this causes little reflection of the pressure wave. On the other hand, in patients with pulmonary hypertension due to increased PVR, augmented pressure (AP) after peak flow due to an earlier and more pronounced pressure reflection has been observed |