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CTRI Number  CTRI/2022/12/048440 [Registered on: 23/12/2022] Trial Registered Prospectively
Last Modified On: 06/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Dapagliflozin in children with heart failure 
Scientific Title of Study   Dapagliflozin in pediatric heart failure with reduced ejection fraction (Dapa-Ped HF) - A randomized pilot study 
Trial Acronym  Dapa-Ped HF 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nabeel Faisal V 
Designation  Senior resident 
Affiliation  All india institute of medical sciences 
Address  Department of cardiology All india institute of medical sciences New delhi

New Delhi
DELHI
110029
India 
Phone  8089680392  
Fax    
Email  nabeelfaisalv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S Ramakrishnan 
Designation  Professor 
Affiliation  All india institute of medical sciences 
Address  Room No 29 Department of cardiology, Cardioneuro center, All india institute of medical sciences, New delhi

New Delhi
DELHI
110029
India 
Phone  9818186179  
Fax    
Email  ramaaiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nabeel Faisal V 
Designation  Senior resident 
Affiliation  All india institute of medical sciences 
Address  Department of cardiology All india institute of medical sciences New delhi


DELHI
110029
India 
Phone  8089680392  
Fax    
Email  nabeelfaisalv@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  Dr Nabeel Faisal V 
Address  Senior resident, Department of cardiology, AIIMS, New delhi 
Type of Sponsor  Other [self] 
 
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 S Ramakrishnan  All india institute of medical sciences  Room No. 29, Department of cardiology, cardioneuro center, All india institute of medical sciences
New Delhi
DELHI 		 9818186179

ramaaiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee for post graduate research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I420||Dilated cardiomyopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dapagliflozin  Dosage (age wise) 1-1.5 year - 1.6mg 1.5 - 2 year - 2mg 2 - 6 year - 2.5mg 6-12 year - 5mg Frequency - Once daily Route of administration - Oral Duration - 6 months 
Comparator Agent  Standard heart failure therapy  The control group will receive standard of care heart failure therapy at optimal dosage. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Age 1 year to <12 years
2. Chronic heart failure resulting from dilated cardiomyopathy and ventricular dysfunction receiving standard of care heart failure therapy
3. NYHA class II-IV (children 6 years to <12 years) or Ross HF classification II-IV (Children <6 years) any time prior to enrolment
4. LV ejection fraction <40% by echocardiogram
5. Etiologies of heart failure include: Idiopathic cardiomyopathy or history of myocarditis.
6. eGFR ≥30 ml/min/1.73 m2 (Shwartz formula) at enrolment
 
 
ExclusionCriteria 
Details  1. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
2. Patient with type I diabetes mellitus
3. Patients with hemodynamically significant structural heart disease operated or unoperated
4. Patients with sustained or symptomatic dysrhythmias not controlled with drug or device therapy
5. HF due to restrictive cardiomyopathy, acute myocarditis (within 3 months of onset), constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, Familial or genetic cardiomyopathy, neuromuscular disease or uncorrected primary valvular disease
6. Symptomatic hypotension or BP below 5th percentile systolic BP for age at enrolment
7. Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
8. Hepatic impairment aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment
9. Severe (eGFR <30 mL/min/1.73 m2 by Schwartz formula), unstable or rapidly progressing renal disease at the time of enrolment.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Composite of
1. First worsening heart failure; defined by signs and symptoms of worsening heart failure that requires intensification of HF therapy.
2. First hospitalization for HF
3. CV death
 		 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
BNP   6 months 
To study the incidence of adverse events
• Serious adverse events
• Discontinuation due to adverse event
• Adverse events of interest
o Volume depletion, renal events
o Electrolyte abnormalities
o Major hypoglycaemic events
o DKA
o Arrhythmias
 		 6 months 
Change in NYHA/ROSS HF class from enrolment to 6 months of therapy   6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2023 
Date of Study Completion (India) 06/11/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Dapaglifozin is shown to reduce mortality in adults with all forms of heart failure. There are case reports and a case series showing safety and benefit of Dapagliflozin in children with heart failure. There are no well-structured studies on the use of dapagliflozin in children with heart failure. The efficacy of the drug needs to evaluated in children as it has been found to effective in adults with HFrEF in reducing heart failure hospitalization and cardiovascular mortality. The drug has been studied in children with proteinuric CKD and diabetes and has not shown any significant safety concern. Hence, in this pilot study, we plan to evaluate the efficacy and safety of dapagliflozin in children with heart failure with reduced ejection fraction. Our objectives are to study the effect of adding Dapagliflozin to standard heart failure therapy in children aged 1 to 12 years and the primary outcome measure is the composite of worsening heart failure, heart failure hospitalizations and cardiovascular death. The study duration is planned for 18 months with enrollment for 12 months and each patient being followed up for 6 months from enrollment. A written informed consent will be obtained from the parent(s) or legal guardian(s) before any study specific procedures are performed. Patient will be given a unique ID on enrolment and eligibility will be checked using the above inclusion and exclusion criteria. Randomization will be performed with computer generated block randomization with unequal block sizes with opaque sealed envelopes assigning them to one of the groups. The first investigator will be blinded regarding which group the patient belong. Dispensing of drugs and optimization of medical and non-pharmacological treatment of heart failure will be done by a second investigator to avoid bias. Treatment group will be provided age-appropriate dose of Dapagliflozin along with standard heart failure therapy. Control group will be given standard of therapy.  
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