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CTRI Number  CTRI/2021/04/032885 [Registered on: 16/04/2021] Trial Registered Prospectively
Last Modified On: 15/04/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Right Ventricle function in reversible pulmonary hypertension 
Scientific Title of Study   Assessment of Right Ventricular Function in Patients with Reversible Pulmonary Arterial Hypertension Secondary to Pulmonary Thromboembolism. 
Trial Acronym  Reversible PAH 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajesh Vijayvergiya 
Designation  Professor Cardiology 
Affiliation  PGIMER 
Address  Advanced Cardiology Center PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9815221856  
Fax    
Email  rajeshvijay999@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rajesh Vijayvergiya 
Designation  Professor Cardiology 
Affiliation  PGIMER 
Address  Advanced Cardiology Center PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9815221856  
Fax    
Email  rajeshvijay999@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Rajesh Vijayvergiya 
Designation  Professor Cardiology 
Affiliation  PGIMER 
Address  Advanced Cardiology Center PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9815221856  
Fax    
Email  rajeshvijay999@hotmail.com  
 
Source of Monetary or Material Support  
PGIMER,Chandigarh 
 
Primary Sponsor  
Name  NIL 
Address  Not applicable  
Type of Sponsor  Other [Not applicable] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Rajesh Vijayvergiya  PGIMER, Chandigarh  Advanced Cardiac Center
Chandigarh
CHANDIGARH 		 9815221856

rajeshvijay999@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I260||Pulmonary embolism with acute corpulmonale,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients diagnosed with hemodynamically significant acute PTE and CTEPH during study period will be included after informed written consent.  
 
ExclusionCriteria 
Details  Patients who did not give consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the echocardiographic findings in patients with CTEPH and acute PTE and at follow up of six months after optimal management.   To study the echocardiographic findings in patients with CTEPH and acute PTE and at follow up of six months after optimal management.  
 
Secondary Outcome  
Outcome  TimePoints 
To study the prevalence of PFO in patients presenting with acute PTE during study period
To study the effect of PFO on clinical presentation of patients
 		 Six months of follow up 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   19/04/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not published yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rajeshvijay999@hotmail.com].

  6. For how long will this data be available start date provided 19-04-2021 and end date provided 19-04-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Echocardiography in setting of acute PTE and CTEPH is routinely done to assess pulmonary artery pressure and RV function. We propose to study the change in pulmonary artery pressure and RV function after management of PTE and CTEPH. We would also document the presence of PFO in patients with PTE and CTEPH, and its effects on clinical presentation of same including saturation (SaO2) and systemic artery oxygen concentration (PaO2). All these patients would be followed up for six months clinically and with detailed echocardiography.

Methodology:

All patients diagnosed with hemodynamically significant acute PTE and CTEPH during study period will be included after informed written consent.

Hemodynamically significant PTE is defined as either of the following(1) persistent hypotension (< 90 mm Hg for over 15 min) not due to hypovolemia and septic shock, or the need for cardiopulmonary resuscitation, or need for  continued support of vasopressors, or hypoxia (SpO2 < 95% on room air); (2) echocardiographic and/or doppler indices suggesting pulmonary hypertension without significant left-heart disease or indices suggestive of right ventricular (RV) dysfunction; (3) Raised biomarkers – BNP and/or NT-pro BNP (in absence of other causes like left heart failure/kidney dysfunction)

The demographic and clinical presentation of patients including relevant investigations will be noted as per the Proforma A & B. A detailed echocardiography with documentation of RV function, pulmonary artery pressure and presence/or absence of patent foramen ovale (PFO) will be done at initial presentation as per Proforma C. PFO will be demonstrated with either of the following methods 1) Contrast echocardiography with or without valsalva  2) Transoesophageal echocardiography (TEE).

The patients will be managed as per the current guidelines. All patients PFO will be followed up for six months. After six months, along with clinical examination, a detailed echocardiography will be done to reassess the RV function and pulmonary artery pressure.


 
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