COVID-19 effects on the heart
- Conditions
- Assessment of heart muscle damage secondary to coronavirus disease (COVID-19) in a hospitalised-recovering patient population (or those recently discharged) with raised cardiac biomarkers (troponin)Infections and InfestationsCOVID-19 (SARS-CoV-2 infection)
- Registration Number
- ISRCTN58667920
- Lead Sponsor
- niversity of Leeds
- Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34112195/ (added 14/06/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36705028/ (added 30/01/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39207330/ (added 02/09/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 386
1. Aged = 18 years
2. Diagnosed with SARS-CoV-2 infection with a raised cardiac biomarker (Troponin)
1. Unable/unwilling to consent
2. Significant renal impairment (eGFR<30ml/min/m²)
3. Female participants who are pregnant, lactating or planning pregnancy during the course of the study
4. Contraindications to MRI (pacemaker, intra-orbital debris, intra-orbital debris, intra-auricular implants, intracranial clips, severe claustrophobia
5. Known hypersensitivity to gadolinium-based contrast agents
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of COVID-19 on the heart at baseline and 6 months:<br>1. Heart abnormalities assessed using MRI<br>2. Heart rhythm and electrical activity assessed using ECG<br>3. Walking ability assessed using 6-min walking test<br>4. Patient-reported health status assessed using SF-36<br>5. Health-related quality of life assessed using EQ-5D
- Secondary Outcome Measures
Name Time Method The influence of comorbidities, age, and genetics measured using medical records monitored from baseline up to 1 year (an optional blood test will be performed at baseline for genetic and immunological testing)