Study identification

EU PAS number

EUPAS34756

Study ID

35231

Official title and acronym

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

DARWIN EU® study

No

Study countries

Argentina
Brazil
Greece
Ireland
Israel
Italy
Netherlands
Spain
United Kingdom
United States

Study description

Patients with heart diseases are a group at risk of developing complications associated with Covid-19 disease. The available information on the evolution, complications, responses to different treatments of patients with inherited heart diseases is extremely scarce. Certain commonly used drugs for these conditions may have an impact on the clinical course of the infection (ACE inhibitors or ARBs). Some antiviral drugs used in the treatment of Covid-19 alter the QT interval and facilitate the onset of arrhythmias. Direct infection of Covid-19 in the myocardium has been reported. The main objective is to describe the clinical course of Covid-19 infection in patients previously diagnosed with an inherited cardiac condition. The secondary objectives are: (1) to assess the relation between previous chronic treatment with ACE inhibitors and ARBs and the severity of Covid-19 infection, and (2) to assess the impact of established antiviral treatments on cardiac disease (heart function, ECG changes, arrhythmias and cardiac complications).Methods: The inclusion criteria are: patients with confirmed Covid-19 infection previously diagnosed with any of the following inherited cardiac diseases: hypertrophic cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic cardiomyopathy, non-compaction cardiomyopathy, long or short QT syndrome, Brugada syndrome or catecholaminergic polymorphic ventricular tachycardia.Participants have to provide informed consent. The project has the approval of the ethics committee of Virgen de la Arrixaca Clinical University Hospital. Data will be collected in a completely anonymous manner prospectively and retrospectively. Participation in the registry does not mean a different diagnosis process or clinical treatment. A specific online database (e-CRF) is available in compliance with all the international data protection regulations and the Spanish and European regulations. This is international registry (EU,UK,America)

Study status

Ongoing
Research institutions and networks

Institutions

Networks

CIBERCV

Contact details

Juan R Gimeno Blanes

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

ISCIII (Spain)
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable