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CTRI Number  CTRI/2024/11/076912 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 15/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   EECP (Enhanced External Counter Pulsation) & HBOT (Hyper Baric Oxygen Therapy) treatment in heart failure 
Scientific Title of Study   EECP (Enhanced External Counter Pulsation) & HBOT (Hyper Baric Oxygen Therapy) as an adjuvant therapy in ischemic cardiomyopathy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
OXY-HFPROS/001, Version: 1.0, Date: 25.07.2024   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sama Akber DNB DM  
Designation  Interventional cardiologist 
Affiliation  Oxymed Hospital 
Address  Department of Cardiology Oxymed Hospital Pvt Ltd 463/710, Anna salai, Nandanam, Chennai

Chennai
TAMIL NADU
600035
India 
Phone  9940259890  
Fax    
Email  dr.samaakber@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sama Akber DNB DM  
Designation  Interventional cardiologist 
Affiliation  Oxymed Hospital 
Address  Department of Cardiology Oxymed Hospital Pvt Ltd 463/710, Anna salai, Nandanam, Chennai

Chennai
TAMIL NADU
600035
India 
Phone  9940259890  
Fax    
Email  dr.samaakber@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sama Akber DNB DM  
Designation  Interventional cardiologist 
Affiliation  Oxymed Hospital 
Address  Department of Cardiology Oxymed Hospital Pvt Ltd 463/710, Anna salai, Nandanam, Chennai

Chennai
TAMIL NADU
600035
India 
Phone  9940259890  
Fax    
Email  dr.samaakber@gmail.com  
 
Source of Monetary or Material Support  
Oxymed Hospital, 463/710, Anna salai, Nandanam, Chennai-600035 
 
Primary Sponsor  
Name  Oxymed Hospital 
Address  463/710, Anna salai, Nandanam, Chennai-600035 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
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 Sama Akber  Oxymed Hospital   Room No.2, Consultation Room, Department of Cardiology, Anna salai, Nandanam, Chennai-600035
Chennai
TAMIL NADU 		 09940259890

dr.samaakber@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Oxymed Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I255||Ischemic cardiomyopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EECP & HBOT   Daily sessions of Hyperbaric oxygen therapy ( 20 x 90 minute sessions ) followed by 40 EECP sessions ( 1 hour each ) over a period of 6 weeks and follow up upto two years 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Ischemic HFrEF( ejection fraction less than 50%) with NYHA Class 2 or more symptoms despite optimal GDMT.
Post revascularization on GDMT with worsening heart failure symptoms.
Coronary anatomy not suitable for repeat revascularization.
 
 
ExclusionCriteria 
Details  Recent acute coronary syndrome (within 1 month).
Recent PTCA ( less than 2 weeks) or CABG (within 3 months).
Severe peripheral arterial disease, greater than Moderate Aortic regurgitation or stenosis, HOCM, severe Mitral regurgitation, DVT , Arterial aneurysms, AFib with FVR , bleeding disorders, and uncontrolled hypertension.
Volume overloaded pts 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
MACE
First hospitalization due to heart failure 		 6 months
1 year
2 year 
 
Secondary Outcome  
Outcome  TimePoints 
All cause mortality.
Change from baseline in the clinical summary on the Minnesota living with heart failure score(MLFHS).
Change from baseline of 6 minute walk distance.
Change from baseline of Global longitudinal strain on 2D echocardiography.
Change from baseline of NT pro BNP. 		 6 months
1 year
2 year 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   29/11/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary  
100 patients with refractory ischemic heart failure with reduced ejection fraction will be included in this study by invitation.
A prospective cohort study design will be employed and patient volunteers will be followed up over a period of 2 years. The volunteers after fulfilling the inclusion exclusion criteria will be subjected to baseline investigations involving 6 MWD, MLHFS, NT pro BNP,  LVEF by Simpson’s biplane method and GLS using 2 dimensional echocardiography.
Patients will be subjected to daily sessions of Hyperbaric oxygen therapy ( 20 x 90 minute sessions ) followed by 40 EECP sessions ( 1 hour each ) over a period of 6 weeks. They will be assessed at the end of therapy with same investigations at baseline. Follow up will continue at frequent intervals at 6 months , 1 year and 2 years.
 
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