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CTRI Number  CTRI/2023/01/049280 [Registered on: 30/01/2023] Trial Registered Prospectively
Last Modified On: 27/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to assess efficacy of Angiotensin Receptor Nephrilysin Inhibitor (Sacubitril/Valsartan) in right ventricular systolic dysfunction with normal LV function” 
Scientific Title of Study   A Prospective Interventional randomized study to assess efficacy of Angiotensin Receptor Nephrilysin Inhibitor (Sacubitril/Valsartan) in right ventricular systolic dysfunction with normal LV function” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Viplov Kesarwani 
Designation  DM resident  
Affiliation  Dr. SN Medical college 
Address  Department of cardiology, MDM Hospital Jodhpur
Residency Road , Jodhpur
Jodhpur
RAJASTHAN
342003
India 
Phone  9416158008  
Fax    
Email  viplovkesarwani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rohit Mathur 
Designation  Associate Professor 
Affiliation  Dr SN Medical College 
Address  Department of cardiology, MDM Hospital Jodhpur
Residency Road, Jodhpur
Jodhpur
RAJASTHAN
342003
India 
Phone    
Fax    
Email  drrohitmathur@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Viplov Kesarwani 
Designation  DM resident  
Affiliation  Dr SN Medical College 
Address  Department of cardiology, MDM Hospital Jodhpur
Residency Road ,Jodhpur
Jodhpur
RAJASTHAN
342003
India 
Phone    
Fax    
Email  viplovkesarwani@gmail.com  
 
Source of Monetary or Material Support  
Institutional MDM Hospital Shastri Nagar , Jodhpur, Rajasthan 
 
Primary Sponsor  
Name  MDM hospitalDr SN Medical College 
Address  Department of cardiology, MDM Hospital Jodhpur 
Type of Sponsor  Government medical college 
 
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 
Dr Viplov Kesarwani  Mdm hospital  Department of cardiology, MDM Hospital Jodhpur
Jodhpur
RAJASTHAN 		 9416158008

viplovkesarwani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I272||Other secondary pulmonary hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No drug  In this group patients will be given their oral usual conventional treatment for 3 months 
Intervention  Sacubitril/Valsartan  starting dose is 50 twice a day orally and depending on blood pressure dose will be titrated upto 200 twice a day and will be given for 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients of Right Ventricular systolic dysfunction with Normal Left ventricular systolic function as diagnosed by transthoracic echocardiography parameters such as TAPSE(<16mm), PAsP(>25mm Hg), tricuspid annular velocity(<10 cm/sec), Fractional area change(<35%) and blood markers such as NT-proBNp(>400pg/ml). 
 
ExclusionCriteria 
Details  1. Patients with LVEF <50%
2. Pregnancy
3. Severe hepatic impairment (Child. Pugh C)
4. Severe renal imapairment (eGFR<30 ml/min/1.73m2)

• Hypersensitivity to any component of the product

• A prior history of angioedema due to an ACEI or ARB
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in clinical ie NYHA class and echo parameter ie TAPSE,PASP,RV S,FAC.  First at baseline,1 month, then at 3 month 
 
Secondary Outcome  
Outcome  TimePoints 
CV death, Hypotension, total HF hospitalization.  CV death, Hypotension, total HF hospitalization over 3 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   30/01/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
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

  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 [viplovkesarwani@gmail.com].

  6. For how long will this data be available start date provided 15-03-2023 and end date provided 14-03-2028?
    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   ARNI is approved for heart failure with reduced ejection fraction.so our study will be aiming to assess efficacy of ARNI in RV systolic dysfunction with normal LV function.so patients will be enrolled and randomized in 2 groups by block randomization and will be assessed at baseline ,1 month, 3 month by blood and echo parameters. 
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