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CTRI Number  CTRI/2024/05/067153 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Disease Area Study 
Study Design  Other 
Public Title of Study   Prevalence of inflammation in patients with cardiovascular disease and heart failure. 
Scientific Title of Study   POSEIDON – Prevalence of systemic inflammation in patients with atherosclerotic cardiovascular disease and heart failure 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NN6018-7527 Version 1.0 dated 17-May-2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Jinu Jose 
Designation  VP, RDS Sales and Clinical Operations, India 
Affiliation  IQVIA RDS (India) Private Limited 
Address  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli

Bangalore
KARNATAKA
560103
India 
Phone  9886203019  
Fax    
Email  jinu.jose@iqvia.com  
 
Details of Contact Person
Public Query
 
Name  Jinu Jose 
Designation  VP, RDS Sales and Clinical Operations, India 
Affiliation  IQVIA RDS (India) Private Limited 
Address  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli


KARNATAKA
560103
India 
Phone  9886203019  
Fax    
Email  jinu.jose@iqvia.com  
 
Source of Monetary or Material Support  
Novo Nordisk A/S, Novo Alle 1 2880 Bagsværd Denmark 2730 
 
Primary Sponsor  
Name  Novo Nordisk AS 
Address  Novo Alle 1, 2880 Bagsværd, Denmark -2730 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Brazil
Canada
China
Czech Republic
Denmark
France
Germany
Hungary
India
Italy
Japan
Norway
Poland
Republic of Korea
Sweden
United Kingdom
United States of America  
Sites of Study  
No of Sites = 18  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suvro Banerjee  Apollo Multispeciality Hospitals   58, Canal Circular Rd, Kadapara, Phool Bagan, Kankurgachi, 700054
Kolkata
WEST BENGAL 
9830024131

drsuvrob@gmail.com 
Dr Jaspal Singh Arneja  Arneja Heart and Multispeciality Hospital  Plot No 123, behind Somalwar High School, Ramdaspeth, 440010
Nagpur
MAHARASHTRA 
7122448721

ypspgi@gmail.com 
Dr Urmil Shah  Care Institute of Medical Sciences  Plot No. 67/1, Near Shukan Mall, Off Science City Road, Sola, 380060
Ahmadabad
GUJARAT 
7927712771

urmil.shah@cims.me 
Dr Gurpreet Singh Wander  Dayanand Medical College & Hospital  Unit - Hero DMC Heart Institute, Tagore Nagar, Civil Lines, 141001
Ludhiana
PUNJAB 
9893042229

drgswander@yahoo.com 
Dr Rakesh Kumar Aggarwal  Deep Hospital  Deep Heart Centre, 481, Model Town, Ludhiana-141002
Ludhiana
PUNJAB 
9814215692

Aggarwal.rakeshkumar@yahoo.com 
Dr Abid Hussain  Gauri Heart Centre  Lal Nagar, Chanapora, 190015
Srinagar
JAMMU & KASHMIR 
9149631214

hakimyasir@hotmail.com 
Dr Veerappa Kothiwale  K.L.E. Societys Dr. Prabhakar Kore Hospital and Medical Research Centre  Front Entrance, NH Service Road, Nehru Nagar, 590019
Belgaum
KARNATAKA 
9448119899

nov10kothiwale@yahoo.co.in 
Dr Jabir Abdullakutty  Lisie Hospital  P.B.NO:3053, Lisie Hospital Rd, North Kaloor, Kochi 682018
Ernakulam
KERALA 
9447011773

drjabi@yahoo.co.in 
Dr Prabhash Manoria  Manoria Heart Care & Critical Care Hospital  A-1/40, Chuna Bhatti, Main Road, Bhopal 462016
Bhopal
MADHYA PRADESH 
9893042229

pmanoria@rediffmail.com 
Dr Sanjay Mittal  Medanta The Medicity  Cardiology Department ,2nd Floor, Room no. 5 Sector-38, 122001
Gurgaon
HARYANA 
9910044477

Sanjay.mittal@medanta.org 
Dr Krishna Malakondareddy Parvathreddy   Osmania Medical College & General Hospital  Dept. of Cardiology, Afzal Gunj, Hyderabad-500012
Hyderabad
TELANGANA 
9848015098

drkmkreddyp@yahoo.com 
Dr Yash Paul Sharma  Postgraduate Institute of Medical Education and Research  Room No. 3012, Advanced Cardiac Centre, Sector 12, Chandigarh- 160012
Chandigarh
CHANDIGARH 
9722756513

ypspgi@gmail.com 
Dr Sudeep Kumar  Sanjay Gandhi Post Graduate Institute Of Medical Sciences  Department of Cardiology, C Block, Old Building, Raebareli Road, 226014
Lucknow
UTTAR PRADESH 
9415016197

sudeep@sgpgi.ac.in 
Dr Atul Abhyankar  Shri B D Mehta Mahavir Heart Institute  Shree Mahavir Health Campus, Athwa Gate, Ring Road, Surat 395001
Surat
GUJARAT 
9825145738

heartfirst.surat@gmail.com 
Dr Tanuj Bhatia  Shri Mahant Indiresh Hospital  Cardiology OPD, Patel Nagar, Dehradun 248001
Dehradun
UTTARANCHAL 
9936618283

tanujbhatia21@rediffmail.com 
Dr Mahesh Fulwani  Shrikrishna Hrudayalaya and Critical Care Centre  Tikekar Rd, Congress Nagar, Square, 440012
Nagpur
MAHARASHTRA 
9921120005

drmaheshfulwani@gmail.com 
Dr Jitendra Pal Singh Sawhney  Sir Ganga Ram Hospital  Department of Cardiology Rajinder Nagar, 110060
New Delhi
DELHI 
9810059773

jpssawhney@yahoo.com 
Dr Mullasari Ajit Sankardas  The Madras Medical Mission  Institute of Cardiovascular Disease, Dr. J.J Nagar, Mogappair, Chennai-600037
Chennai
TAMIL NADU 
4426565961

icvddoctors@mmm.org.in 
 
Details of Ethics Committee  
No of Ethics Committees= 18  
Name of Committee  Approval Status 
Arnejas Institutional Ethics Committee  Approved 
Drug Trials Ethics Committee  Approved 
Ethics Committee - Gauri Research Centre  Approved 
IEC- Manoria Heart Care Centre Pvt. Ltd  Approved 
Institutional Ethics Committee Apollo Gleneagles Hospital, Kolkata  Submittted/Under Review 
Institutional Ethics Committee The Madras Medical Mission  Approved 
Institutional Ethics Committee Deep Hospital  Approved 
Institutional Ethics Committee KLE University  Submittted/Under Review 
Institutional Ethics Committee of CIMS  Approved 
Institutional Ethics Committee Osmania Medical College  Submittted/Under Review 
Institutional Ethics Committee Post Graduate Institute of Medical Education and Research  Submittted/Under Review 
Institutional Ethics Committee Sanjay Gandhi Post Graduate Institute Of Medical Sciences  Submittted/Under Review 
Institutional Ethics Committee SGRR Institute of Medical Health Sciences  Submittted/Under Review 
Institutional Ethics Committee, Lisie Hospital  Approved 
Medanta - Institutional Ethics Committee  Approved 
Shri B D Mehta Mahavir Heart Institute Ethics Committee  Approved 
Sir Ganga Ram Hospital Ethics Committee  Submittted/Under Review 
Virtuous Institutional Medical Research EC, Shrikrishna Hrudayalaya and Critical Care Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study.
2. Age 18 years or above at the time of signing the informed consent.
3. Presence of ASCVD and/or HF.
4. Presence of serum creatinine in the medical chart within 24 months prior to signing of informed consent (for ASCVD patients only). 
 
ExclusionCriteria 
Details  1. Previous participation in this study. Participation is defined as having given informed
consent in this study.
2. Current participation (i.e., signed informed consent) in any other interventional clinical
study.
3. Any hospitalization or unplanned visit within the last 60 days (including exacerbation of
chronic disease with hospitalization).
4. Clinical evidence, or suspicion of, active infection within the last 60 days.
5. Mental incapacity, unwillingness, or language barriers precluding adequate understanding
or cooperation 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To estimate the prevalence of systemic inflammation (defined as hsCRP ≥2 mg/L) in pre-defined cohorts of patients with ASCVD and/or HF, and subgroups hereof.  Primary objective will be assessed during subject visit date and there is only one subject visit in this study. 
 
Secondary Outcome  
Outcome  TimePoints 
• To examine IL-6 stratified by the presence of systemic inflammation (defined as hsCRP ≥2 mg/L) in pre-defined cohorts of patients with ASCVD and/or HF, & subgroups hereof.
• To examine NT-proBNP stratified by the presence of systemic inflammation (defined as hsCRP ≥2 mg/L) in pre-defined cohorts of patients with HF, & subgroups hereof.
 
Secondary objective will be assessed during subject visit date & there is only one subject visit in this study. 
 
Target Sample Size   Total Sample Size="21504"
Sample Size from India="1536" 
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)   15/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/11/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

This is a cross-sectional, global, real-world prevalence study involving patients diagnosed with ASCVD and/or HF. There is only 1 planned study visit, during which patients will sign an informed consent form (ICF) and provide a blood sample. All efforts should be made to collect a blood sample at time of ICF signature, however if a patient is unable to provide a blood sample during this visit, they are permitted to return within 2 weeks of ICF signature. Full patient data will only be abstracted from patient records after a patient has provided a blood sample, and data will be abstracted to the date of the blood sample. Patients are recommended to be in a fasted state for collection of the blood sample, but this is not a requirement. In order to facilitate the required blood sample collection, sites may review patients’ medical charts to determine eligibility of patients with upcoming visits, discuss the study with the patient, and plan for the blood test to be performed during the same visit as ICF signature.

Patients will be invited sequentially to participate in the study during a 17-month enrolment period as they present for a routine visit to minimize bias in patient selection, and all eligible patients should be offered enrolment in the study.

Patients will be enrolled into the study and attributed to 4 pre-defined cohorts (note that patients may contribute to more than 1 cohort). This study defines CKD as having an estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2.

1. ASCVD with CKD (eGFR <60 ml/min/1.73m2)

2. ASCVD without CKD (eGFR ≥60 ml/min/1.73m2)

3. HF with preserved ejection fraction (HFpEF) or HF with mildly reduced ejection fraction (HFmrEF)

4. HF with reduced ejection fraction (HFrEF)


 
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