| 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 |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NN6018-7527 Version 1.0 dated 17-May-2023 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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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 |
|
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Source of Monetary or Material Support
|
| Novo Nordisk A/S, Novo Alle 1
2880 Bagsværd
Denmark 2730 |
|
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Primary Sponsor
|
| Name |
Novo Nordisk AS |
| Address |
Novo Alle 1, 2880 Bagsværd, Denmark -2730 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
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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 |
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
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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 |
|
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Method of Generating Random Sequence
|
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Method of Concealment
|
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Blinding/Masking
|
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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. |
|
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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. |
|
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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" |
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Phase of Trial
|
N/A |
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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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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) |