COVID-19 IN PATIENTS WITH HEART FAILURE AND INHERITED CARDIAC CONDITIONS (C19-ICC)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Hypertrophic cardiomyopathy

  Cardiomyopathy

  Brugada syndrome

  Long QT syndrome

  Arrhythmogenic right ventricular dysplasia

  Cardiac failure
• Additional medical condition(s):
  Confirmed Covid-19 infection previously diagnosed with: hypertrophic cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic cardiomyopathy, non-compaction cardiomyopathy, long or short QT syndrome, Brugada syndrome or catecholaminergic polymorphic ventricular tachycardia. (All centres)Additionally patiets with prior diagnosis of heart failure (for Spanish & Argentina)

Population studied

• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  The main objective is to describe the clinical course of Covid-19 infection in patients previously diagnosed with (1) an inherited cardiac condition and/or (2) prior diagnosis of heart failure.
• Outcomes:
  The main grouping and comparison variables established for the main objective are variables regarding infection severity (need of hospitalisation, admission to ICU) and regarding complications (Covid-19-related mortality or heart-disease-related mortality). Impact of established antiviral treatments on cardiac disease (heart function, ECG changes, arrhythmias and cardiac complications).
• Data analysis plan:
  The first list of variables to input has already been agreed upon and includes a set of 145 variables classified into: demographic data, previous diagnoses and risk factors, previous treatments, symptoms and pre-infection functional status, clinical data at the time of hospitalisation (examination, blood tests and complementary tests), treatments and surgeries during infection-hospitalisation, duration of processes, hospitalisations, ICU care, and events. We expect to complete the registry with follow-up variables not defined yet.The main grouping and comparison variables established for the main objective are variables regarding infection severity (need of hospitalisation, admission to ICU) and regarding complications (Covid-19-related mortality or heart-disease-related mortality). Statistical analysis includes a descriptive part, association analysis, survival analysis and multivariate analysis.Stats analysis will be performed every 2 weeks (first 3 mo) and then every 2 months.

Documents

Study, other information

List of centres 21April2020a