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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 Study”) 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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