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CTRI Number  CTRI/2024/12/078330 [Registered on: 19/12/2024] Trial Registered Prospectively
Last Modified On: 18/12/2024
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 study the effect of two drugs, inhaled milrinone and inhaled levosimendan in children with pulmonary hypertension. 
Scientific Title of Study   The effect of inhaled milrinone and inhaled levosimendan in pulmonary hypertension in children with congenital heart disease- A randomized double blinded trial. 
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 Rajeswari N  
Designation  Senior consultant  
Affiliation  Apollo hospitals enterprises limited  
Address  Picu Apollo children hospital Chennai
PICU, Apollo children’s hospital Thousand lights, Nungambakkam, Chennai
Chennai
TAMIL NADU
600006
India 
Phone  9884058200  
Fax    
Email  rajiarali@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rajeswari N  
Designation  Senior consultant  
Affiliation  Apollo hospitals enterprises limited  
Address  PICU Apollo children hospital Chennai
PICU, Apollo children’s hospital Thousand lights, Nungambakkam, Chennai
Chennai
TAMIL NADU
600006
India 
Phone  8905346895  
Fax    
Email  rajiarali@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rajeswari N  
Designation  Senior consultant  
Affiliation  Apollo hospitals enterprises limited  
Address  PICU Apollo children hospital Chennai
PICU, Apollo children’s hospital Thousand lights, Nungambakkam, Chennai
Chennai
TAMIL NADU
600006
India 
Phone  8905346895  
Fax    
Email  rajiarali@gmail.com  
 
Source of Monetary or Material Support  
Apollo children hospital Chennai  
 
Primary Sponsor  
Name  Apollo hospitals enterprises limited  
Address  Apollo children’s hospital Nungambakkam Chennai  
Type of Sponsor  Private hospital/clinic 
 
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 Rajeswari N   Apollo children’s hospital   Cath lab ,3rd floor, Apollo children’s hospital Thousand lights, Nungambakkam, Chennai
Chennai
TAMIL NADU 		 08905346895

vageeshkm93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee - biomedical research, Apollo hospitals, Chennai   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 
Intervention  Inhaled Levosimendan  Children with congenital heart disease with pulmonary hypertension defined as mean pulmonary artery pressure more than or equal to 25mmHg undergoing right heart catheterisation study will be given inhaled Levosimendan after randomisation for duration of 15minutes  
Comparator Agent  Inhaled milrinone  Children with congenital heart disease with pulmonary hypertension defined as mean pulmonary artery pressure more than or equal to 25mmHg undergoing right heart catherisation study will be given inhaled milrinone after randomisation for a duration of 15minutes  
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children with cyanotic or acyanotic heart disease with pulmonary hypertension defined by mean pulmonary artery pressures more than or equal to 25mmHg will be enrolled in the study 
 
ExclusionCriteria 
Details  Patients who did not show response to 100% oxygen during the right heart catheter study.
Patients not willing for the study  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare acute effects of inhaled milrinone and inhaled levosimendan on pulmonary and systemic vascular resistance and on pulmonary blood flows, systemic blood flow and pulmonary to systemic blood flow ratio.  After completion of nebulization of each drug that is after 15minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the acute effects of inhaled milrinone and inhaled levosimendan on oxygenation saturain aorta , pulmonary artery and mixed venous saturation and 2D echocardiography parameters RVOT doppler profile pulmonary artery acceleration time and volume time integral   After the completion of inhalation of the drugs over 15 to 20 minutes  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 4 
Date of First Enrollment (India)   30/12/2024 
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="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 - 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
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [vageeshkm93@gmail.com].

  6. For how long will this data be available start date provided 22-10-2024 and end date provided 22-10-2029?
    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   This study is a Randomised double-blinded parallel group trial to study the acute effects of inhaled milrinone and inhaled levosimendan in pulmonary hypertension in children with congenital heart disease for 12 months in 40 patients. The primary outcome will be acute effects of the drugs on the pulmonary vascular resistance, systemic vascular resistance and pulmonary blood flows, systemic blood flows, pulmonary to systemic blood flow ratio. The secondary outcomes will be acute effects of the drugs on oxygen saturation in aorta, pulmonary artery, mixed venous saturation and2D echocardiography parameters RVOT profile pulmonary artery acceleration time and volume time integral. 
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