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CTRI Number  CTRI/2024/11/076660 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 26/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of statins in preventing decline in heart function in patients with permanent pacemaker 
Scientific Title of Study   Efficacy of statins to reduce the incidence of pacemaker induced cardiomyopathy – An open label randomized controlled 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  Rohit Varma 
Designation  Senior Resident, Cardiology 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Room No 184, Superspeciality Block, Jawaharlal Institute of Postgraduate Medical Education and Research,JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  7977302079  
Fax    
Email  varma.rohit93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Raja Selvaraj 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Room No 184, Superspeciality Block, Jawaharlal Institute of Postgraduate Medical Education and Research,JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9442242648  
Fax    
Email  rajajs@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rohit Varma 
Designation  Senior Resident, Cardiology 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Room No 184, Superspeciality Block, Jawaharlal Institute of Postgraduate Medical Education and Research,JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  7977302079  
Fax    
Email  varma.rohit93@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research,JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006, India 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006 
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 Rohit Varma  Jawaharlal Institute of Postgraduate Medical Education and Research  Room No 184, Superspeciality Block, Jawaharlal Institute of Postgraduate Medical Education and Research,JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY 		 7977302079

varma.rohit93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Jawaharlal Institute of Postgraduate Medical Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I442||Atrioventricular block, complete,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Administration of Atorvastatin 40 mg/day  Atorvastatin 40 mg per day will be given orally for 1 year to the patients (with permanent pacemaker) in study group along with standard medical treatment 
Comparator Agent  Control group  Patients in control group (with permanent pacemaker) will receive standard medical therapy for 1 year, but will not be prescribed statins 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Underwent pacemaker implantation within three days
2.Anticipated ventricular pacing requirement more than 40%
 
 
ExclusionCriteria 
Details  1.Patients with LVEF < 50%
2.Patients who are already on statins or have an indication for statins
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Development of pacemaker induced cardiomyopathy  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of elevated NT-proBNP levels at six months in both the statin and control group  6 months 
 
Target Sample Size   Total Sample Size="202"
Sample Size from India="202" 
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)   22/11/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   The primary purpose of this protocol is to assess the effectiveness of statins in decreasing the incidence of pacemaker-induced cardiomyopathy (PICMP) among patients receiving permanent pacemakers. Right ventricular pacing can lead to left ventricular dysfunction over time, resulting in PICMP, with an incidence reported between 5% to 30% of cases. This study hypothesizes that daily administration of 40 mg of atorvastatin will mitigate PICMP incidence by stabilizing cardiac function over a 1-year period. Should the results prove favorable, this intervention could support the routine use of statins as a preventive measure in pacemaker patients, ultimately aiming to improve their long-term cardiac outcomes and reduce progression to heart failure. 
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