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Table of Contents
ORIGINAL ARTICLE
Year : 2020  |  Volume : 10  |  Issue : 2  |  Page : 75-78

Rationale, methodology, and design of Indian College of Cardiology National Heart Failure Registry


1 Director and Senior Interventional Cardiologist, Lakshmi Hospital, Palakkad, Kerala, India
2 Director and Professor of Cardiology, Sri Jayadeva Institute of Cardiovascular Science and Research, Bangalore, Karnataka, India
3 Senior Consultant Cardiologist, Lisie Hospital, Kochi, Kerala, India
4 Chairman and Interventional Cardiologist, G. Kuppuswamy Naidu Memorial Hospital, Coimbatore, Tamil Nadu, India
5 HOD & Consultant Cardiologist, Caritas Hospital, Kottayam, Kerala, India
6 Associate Professor of Cardiology, Sri Jayadeva Institute of Cardiovascular Science and Research, Mysore, Karnataka, India
7 Professor of Cardiology, Sri Jayadeva Institute of Cardiovascular Science and Research, Bangalore, Karnataka, India

Date of Submission21-Mar-2020
Date of Decision09-Apr-2020
Date of Acceptance11-Apr-2020
Date of Web Publication25-Sep-2020

Correspondence Address:
Dr. P B Jayagopal
Lakshmi Hospital, Chittur Road, Palakkad - 678 013, Kerala
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/JICC.JICC_13_20

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  Abstract 


Aims: Heart Failure (HF) is a growing epidemic globally and a challenging situation particularly for a country like India. There is paucity of data in the Indian context and the Indian College of Cardiology National Heart Failure Registry (ICCNHFR) would be the first of its kind in understanding the aetiology, demographics and treatment pattern in the country. The rationale and design of the study is described. Methods and Results: This is a prospective observational registry study of Acute Decompensated Heart Failure (ADHF) across various hospitals in India. This would include data of consecutive adult patients admitted with acute heart failure in the hospitals. This study is from Sep 2019 to Sep 2021 and is expected to enroll about 10000 patients. The primary data would be to analyse the demographics, aetiology, comorbid conditions, inhospital mortality, 30 day and one year mortality and rehospitalisation. The secondary aim would be understand the diagnostic patterns and therapeutic options offered for these patients.Conclusion: The present registry is designed to analyse the national data on ADHF. This would identify gaps in HF care and therapy. This would help in improving quality of heart failure care in the country and better resource utilization. This will help in the reduction of mortality and morbidity rate related to HF

Keywords: Acute decompensated heart failure, Heart Failure, National Heart Failur Registry


How to cite this article:
Jayagopal P B, Manjunath C N, Raghu T R, Abdullakutty J, Vaidyanathan P R, Joseph J, Nanjappa V, Sridhar L. Rationale, methodology, and design of Indian College of Cardiology National Heart Failure Registry. J Indian coll cardiol 2020;10:75-8

How to cite this URL:
Jayagopal P B, Manjunath C N, Raghu T R, Abdullakutty J, Vaidyanathan P R, Joseph J, Nanjappa V, Sridhar L. Rationale, methodology, and design of Indian College of Cardiology National Heart Failure Registry. J Indian coll cardiol [serial online] 2020 [cited 2020 Oct 27];10:75-8. Available from: https://www.joicc.org/text.asp?2020/10/2/75/296118




  Introduction Top


Heart failure (HF) is a leading cause of mortality and morbidity in today's world. Over the last few decades, there has been a substantial increase in the incidence of HF. It is estimated that about 23 million people are affected worldwide,[1] and it is expected that one in 33 would have HF by 2030.[2] The overall prevalence of HF in the United States is reported to be 1.9%.[3] With increasing age, higher incidence of hypertension, diabetes mellitus, chronic kidney disease, and ischemic heart disease, there is indeed a higher chance of incidence of HF in a country like India.[4] There are less data in the country collected on the prevalence of HF, unlike in the Western countries. Based on available data and extrapolating the figures from Western countries, it is reasonable to believe that the prevalence in India is about 1%, thus accounting for 8–10 million cases and an expected mortality of 0.1–0.16 million per year.[5]

Initial attempts to capture the data on HF were from individual hospitals in the country. The largest published data are from Trivandrum,[6],[7] which have thrown some light into the demographics, hospital mortality, and follow-up. The subset of patients from India in the INTER-CHF [8] trial is also very small. All these have shown a grim and gloomy picture regarding the treatment patterns and prognosis of HF in the nation. Hence, there is a need for comprehensive national data looking into the demographics, practice patterns, inhospital mortality, and drug compliance. It is correct to mention that the present outlook for HF in the country is worse than cancer as the 1-year mortality is seen to be close to 30%.[1] Once solid data are available, there is scope for identifying the gaps in therapy. Strategies could be drawn in light of these data for better resource utilization and proper framing of policies in the treatment of HF. The economic impact would be huge for a country like India, and it is with this background that the Indian College of Cardiology (ICC) designed this study.

Aim and objectives of the study

This is to document the demographics, clinical presentation, etiology, comorbid conditions, and diagnostic and therapeutic strategies in patients admitted with acute decompensated HF (ADHF) in both government and private hospitals across various states in the country [Figure 1].
Figure 1: More centers from north, east, and west zones are expected to join in coming months

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Specific objectives are:

  1. To document the demographics, clinical patterns, etiology, and comorbid conditions in patients with ADHF in India
  2. To document the diagnostic approach, treatment, and practice patterns in various hospitals across India
  3. To estimate the inhospital mortality, 30-day mortality, and rehospitalization rates
  4. Long-term follow-up on medical therapy and mortality
  5. To understand the economic impact and the type of population involved.



  Materials and Methods Top


The ICC National Heart Failure Registry registered under the Clinical Trial Registry of India (Registration No: CTRI/2019/08/020972) is planned as a prospective study. The plan is to enroll 10,000 patients admitted with ADHF, in private and government hospitals across India. All major hospitals in the country are contacted and centers willing to participate are included. These centers would represent different parts of the country. The list of confirmed participant centers of ICC National Heart Failure Registry is in the appendix.[1] Some of them had earlier participated in a pilot study, which made it easier to ensure good-quality data.

The individual centers would enroll consecutive patients admitted in the hospital with ADHF after getting a written consent.

Inclusion criteria

All patients above 18 years of age with a clinical diagnosis admitted with ADHF in the hospital are included in the study. The inclusion criteria are based on the European Society of Cardiology 2012 criteria for diagnosing HF.[9] This is defined as symptoms and signs of acute HF, supported by echo evidence of systolic or diastolic dysfunction and/or biomarker (BNP/NTpro BNP) elevation as per the ESC 2016 guidelines.[10]

This could be de novo HF or acute on chronic HF.

Exclusion criteria

This includes patients not willing to participate or not willing to be under follow-up.

Patient recruitment and data collection

The data collection is through an Electronic Case Report Form (E-CRF) entry through a dedicated software, which was tested and validated by a pilot study from 22 centers. This is designed and developed by Tedsys Technologies Pvt. Ltd., and privacy is ensured by a password-protected option available only to the participating center. The detailed process and formatting is as per [Figure 2]. This study is coordinated by a central nodal station located at Lakshmi Hospital, Palakkad. Every participating center would have a coinvestigator and a site coordinator. The site coordinator and the nurse/physician incharge would ensure prompt and correct entry of the data. The demographic data, clinical variables, biochemical tests, echo, various investigations, and medications are described in the appendix.[2]
Figure 2: Indian College of Cardiology National Heart Failure Registry process

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The central coordinator, project assistant, and the project manager would coordinate the training, participation, and enrollment of patients in the registry with the help of coinvestigator and site coordinators.

The site coordinator is responsible for accurate data collection and would periodically audit the team. Further at random, auditing suggested by the nodal team project assistant would also occur. An independent audit of 10% of centers would also ascertain the quality of data.

Data analysis and management

Once the data collection takes place, the follow-up is at the end of 30 days, 6 months, and 1 year. This could be either clinical/telephonic. This is mostly to capture the mortality, rehospitalization, and adherence to medical treatment. The analysis of the data acquired would be through an independent agency.

Daily checking of the data and reminders to the investigator for missing data is ensured. Further clarifications and completion of the data are taken up with the site coordinator periodically. An update on the patient enrollment numbers and status of complete and incomplete data is sent by E-mail every week with a color coding for easy rectification. This database is locked, and no editing of data beyond that period is permitted. The target is to enroll 10,000 patients within 2 years.

Funding and investigators

The study is funded by the ICC which is a nonprofit organization involved in academic and research activities. The principal investigator and the investigators are all involved in many registries done in the country and are at the forefront of various research activities.

Ethical clearance

All participating centers are required to have the study cleared by their local institute ethics committee. This study is registered under Clinical Trials Registry - India (CTRI), and centers would get added on after statutory clearance suggested by CTRI.

Impact of the study

Very scant data are available in ADHF in the country. This would be a continuation of the pilot registry data and would reinforce our base for planning future strategies in diagnosing and improving the outcome for HF patients in the country. Moreover, it gives an opportunity for centers to get involved in research which improves the quality of care and treatment as clearly shown by the Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) registry.

A simple checklist for appropriate medications and involving nurses and social personnel for ensuring adherence to guideline-based medications and periodic follow-up would indeed be the immediate solution. Such attempts would help in figuring out cost-effective innovative methods to improve HF outcomes in a resource-challenged nation.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Bui AL, Horwich TB, Fonarow GC. Epidemiology and risk profile of heart failure. Nat Rev Cardiol 2011;8:30-41.  Back to cited text no. 1
    
2.
Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, et al. Forecasting the impact of heart failure in the United States: A policy statement from the American Heart Association. Circ Heart Fail 2013;6:606-19.  Back to cited text no. 2
    
3.
Komanduri S, Jadhao Y, Guduru SS, Cheriyath P, Wert Y. Prevalence and risk factors of heart failure in the USA: NHANES 2013-2014 epidemiological follow-up study. J Community Hosp Intern Med Perspect 2017;7:15-20.  Back to cited text no. 3
    
4.
Huffman MD, Prabhakaran D. Heart failure: Epidemiology and prevention in India. Natl Med J India 2010;23:283-8.  Back to cited text no. 4
    
5.
Chaturvedi V, Parakh N, Seth S, Bhargava B, Ramakrishnan S, Roy A, et al. Heart failure in India: The INDUS (INDiaUkieri Study) study. J Pract Cardiovasc Sci 2016;2:28-35.  Back to cited text no. 5
  [Full text]  
6.
Harikrishnan S, Sanjay G, Anees T, Viswanathan S, Vijayaraghavan G, Bahuleyan CG, et al. Clinical presentation, management, in-hospital and 90-day outcomes of heart failure patients in Trivandrum, Kerala, India: The Trivandrum Heart Failure Registry. Eur J Heart Fail 2015;17:794-800.  Back to cited text no. 6
    
7.
Harikrishnan S, Sanjay G, Agarwal A, Kumar NP, Kumar KK, Bahuleyan CG, et al. One-year mortality outcomes and hospital readmissions of patients admitted with acute heart failure: Data from the Trivandrum Heart Failure Registry in Kerala, India. Am Heart J 2017;189:193-9.  Back to cited text no. 7
    
8.
Dokainish H, Teo K, Zhu J, Roy A, AlHabib KF, ElSayed A, et al. Global mortality variations in patients with heart failure: Results from the International Congestive Heart Failure (INTER-CHF) prospective cohort study. Lancet Glob Health 2017;5:e665-e672.  Back to cited text no. 8
    
9.
Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC), European Association for Cardio-Thoracic Surgery (EACTS), Vahanian A, Alfieri O, Andreotti F, Antunes MJ, et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 2012;33:2451-96.  Back to cited text no. 9
    
10.
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJS, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J 2016;37:2129-200.  Back to cited text no. 10
    


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