| CTRI Number |
CTRI/2021/04/032864 [Registered on: 16/04/2021] Trial Registered Prospectively |
| Last Modified On: |
28/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of COVID-19 on Heart Failure Hospitalization and Outcome in India – A Cardiological Society of India Study |
|
Scientific Title of Study
|
Impact of COVID-19 on Heart Failure Hospitalization and Outcome in India – A Cardiological Society of India Study (CSI-HF in COVID 19 Times Study – “The COVID C-HF Studyâ€) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayagopal P B |
| Designation |
Senior Consultant Cardiologist |
| Affiliation |
Director and Senior Interventional Cardiologist |
| Address |
Lakshmi Hospital, Chittur Road, Palakkad
Palakkad KERALA 678013 India |
| Phone |
9847023777 |
| Fax |
|
| Email |
csichfcovidstudy@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jayagopal P B |
| Designation |
Senior Consultant Cardiologist |
| Affiliation |
Director and Senior Interventional Cardiologist |
| Address |
Lakshmi Hospital, Chittur Road, Palakkad
Palakkad KERALA 678013 India |
| Phone |
9847023777 |
| Fax |
|
| Email |
csichfcovidstudy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jayagopal P B |
| Designation |
Senior Consultant Cardiologist |
| Affiliation |
Director and Senior Interventional Cardiologist |
| Address |
Lakshmi Hospital, Chittur Road, Palakkad
Palakkad KERALA 678013 India |
| Phone |
9847023777 |
| Fax |
|
| Email |
csichfcovidstudy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cardiological Society of India, P-60, C.I.T Road, Scheme VII-M, Kankurgachi, Kolkata - 700054, India |
|
|
Primary Sponsor
|
| Name |
Cardiological Society of India |
| Address |
P-60, C.I.T Road, Scheme VII-M, Kankurgachi, Kolkata - 700054, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jayagopal P B |
Lakshmi Hospital |
Ground floor, A Block, Cardiology Dept., Room No 3, Coimbatore Rd, Prathiba Nagar, Palakkad 678013, Palakkad KERALA |
9847023777
jaigopallakshmi@gmail.com |
| Dr Jabir Abdullakutty |
Lisie Hospital |
5th Floor, Cardiology Research Dept., Lisie Heart Institute, Kacheripady PO, Eranakulam Ernakulam KERALA |
9447011773
lisieresearch@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Heart and General Hospital, Jaipur |
Approved |
| Kamalnayan Bajaj Hospital, Aurangabad |
Approved |
| Lakshmi Hospital, Palakkad |
Approved |
| Lisie Hospital |
Approved |
| Little Flower Hospital and Research Center |
Approved |
| SAL Hospital, Ahmedabad |
Approved |
| SCB Medical College & Hospital, Cuttack |
Approved |
| Sri Jayadeva Institute Ethics Committee, Bangalore |
Approved |
| The Madras Medical Mission Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I504||Combined systolic (congestive) anddiastolic (congestive) heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
In this multicentric, retrospective, cross-sectional registry, we plan to retrospectively include consecutive patients presenting with acute HF at various participating hospitals across the Indian states/ union territories during a 6-months period in 2020 (1st of July to 31st December 2020). All cases of acute HF admitted during the corresponding period in the year 2019 will serve as historical controls.The parameters to be studied include type of HF, new-onset or worsening of pre-existing heart failure, clinical characteristics on index admission, risk factors, etiology for heart failure, history previous myocardial infarction, history of previous hospital admissions, treatment received during hospital admission, diagnostic coronary angiography, percutaneous coronary interventions, and coronary artery bypass graft surgery rates. |
|
| ExclusionCriteria |
| Details |
Patients with a first acute myocardial infarction in the 2 weeks preceding clinical presentation will be excluded. Patients with alternative diagnoses clearly causative of symptoms will also be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the change in the number of acute HF admissions in various hospitals in India during the period from 1st of July to 31st December 2020 (COVID-19 era) compared to corresponding period in 2019.
2.To study in-hospital mortality rates of ADHF admitted to the various hospitals during the COVID-19 era compared to corresponding period in 2019.
3.To study care of patients with LVAD and Heart transplant during COVID-19 times
4.To study the benefits of prophylaxis with HCQ/others
|
The period from 1st of July to 31st December 2020 (COVID-19 era) compared to corresponding period in 2019 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To find out type of HF (HFpEF vs HFrEF), and rates of guideline directed medical therapy (GDMT), coronary angiography and revascularization in HF patients.
2.To evaluate the differences in the number of various advanced HF procedures performed in 2020 Vs. 2019 including ICD, CRT, mechanical assist devices and heart transplantation by a survey among the hospitals.
3.To study the changes in the prescription pattern of ACE inhibitor/ARB/ARNI. |
The period from 1st of July to 31st December 2020 (COVID-19 era) compared to corresponding period in 2019 |
|
|
Target Sample Size
|
Total Sample Size="40000" Sample Size from India="40000"
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)
|
19/04/2021 |
| 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="0" Months="1" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Part 1. Individual patient based acute HF retrospective registry 2020 Vs 2019: In this multicentric, retrospective, cross-sectional registry, we retrospectively include consecutive patients presenting with acute HF at various participating hospitals across the country during a 6-months period in 2020 (1st of July to 31st December 2020). All cases of acute HF admitted during the corresponding period in the year 2019 will serve as historical controls. Patients with a first acute myocardial infarction in the 2 weeks preceding clinical presentation will be excluded. Patients with alternative diagnoses clearly causative of symptoms will also be excluded. The 2016 European Society of Cardiology (ESC) criteria (12) will be used to define cases of heart failure. The parameters to be studied include type of HF, new-onset or worsening of pre-existing heart failure, clinical characteristics on index admission, risk factors, etiology for heart failure, history previous myocardial infarction, history of previous hospital admissions, treatment received during hospital admission, diagnostic coronary angiography, percutaneous coronary interventions, and coronary artery bypass graft surgery rates. Part 2. Hospital statistics on HF-related procedures We wish to find the differences in the number of various advanced HF procedures. In a predesigned proforma we will collect the total numbers of ICD, CRT, mechanical assist devices including IABP for HF, percutaneous devices, LVAD and heart transplantations performed in the study period in 2020 as compared to corresponding volumes in 2019. Part 3. Utility of Teleconsultation in HF |