One-year Cardiac Follow-up of Patients With COVID-19 Pneumonia
Conditions: Covid19, Cardiac Complication
Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian 
Academy of Science, Tomsk, Russia 
 
 
 
 
 
 
 
 
 
One-year Cardiac Follow-up of COVID-19 Pneumonia (159) 
Study Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
13/07/2020 

Brief Summary: The primary objective of the study is to assess the cardiac status of 
COVID-19 pneumonia patients during 1 year after discharge. 
 
Although COVID-19 manifests in most cases with respiratory symptoms, 
cardiovascular abnormalities is common in hospitalized patients. Patients with 
cardiovascular risk factors or established disease appear to have a worse prognosis. 
Myocardial dysfunction could represent a direct manifestation of COVID-19. Investigation 
of the long-term cardiovascular consequences of COVID-19 is needed. Subjects after 
COVID-19 pneumonia can present myocardial remodeling for a long time after discharge, 
even in the absence of prior cardiovascular disease. 
 
Keywords: 
Covid19; Cardiovascular Disease; Echocardiography 
 
Hypothesis: In patients with COVID-19 pneumonia initiates and aggravates the 
processes of structural and functional remodeling of the myocardium within 1 year after 
discharge from the hospital. 
 
Primary Outcome Measure: 
Echocardiographic assessment of cardiac function. Echocardiographic assessment of 
global strain parameters at 3 and 12 months after discharge 
[Time Frame: up to one year] 
 
Secondary Outcome Measures: 
1. МАССЕ. Major adverse cardiac and cerebrovascular events: cardiac death, 
myocardial infarction, or stroke at 3 and 12 months after discharge 
[Time Frame: up to one year] 
2. Quantitative analysis of parenchymal lung damage. Describe the parenchymal lung 
damage through a quantitative analysis with chest CT at 3 and 12 months after 
discharge 
[Time Frame: up to one year] 
3. Functional exercises capacity assessment. Six-min walk test at 3 and 12 months 
after discharge 
[Time Frame: up to one year] 
4. Evaluation of renal function. Measure of creatinine clearance at 3 and 12 months 
after discharge 
[Time Frame: up to one year] 
5. Evaluation of inflammation. Analysis for C-reactive protein at 3 and 12 months after 
discharge 
[Time Frame: up to one year] 
6. Evaluation of coagulation abnormality. Analysis for activated clotting time at 3 and 
12 months 
[Time Frame: up to one year] 
7. Evaluation of quality of life in first year after discharge. Assessment of the Short 
Form Health Survey (SF36) at 3 and 12 months after discharge 
[Time Frame: up to one year] 
The objective of the study is to evaluate the impact of COVID-19 pneumonia on 
transthoracic echocardiography and other myocardial parameters during 1 year follow-up 
to monitor cardio-vascular events and predict outcomes. 

 
Population. According to the protocol, the study included men and women ≥18 years 
old with documented COVID-19 pneumonia 3 month ± 2 week after discharge. The sample 
size is 380 people (calculation by the Cochran method and Raosoft calculator). The 
observation period was 12 months ± 2 weeks. The planned terms of inclusion in the study 
are the end of December 2020. 
Design: The prospective observational study includes men and women ≥18 years 
old who were 3 month ± 2 week ago discharged after documented COVID-19 pneumonia. 
Patients were identified from medical information system of local COVID hospital 
between April and December 2020. The study will performed in concordance with the 
International Conference on Harmonization of Good Clinical Practice and the Declaration 
of Helsinki. The study protocol was approved by the local ethics committee (Approval 
Number: 159 from 07/23/2020). Every patient is explained the purpose of the study and 
benefits of participation. If the patient agrees to participate in the study, he signs an 
informed consent. All patients included have negative results on a swab test at the end of 
the hospitalization. Exclusion criteria were impossibility to follow up, cancer, tuberculosis. 
Patients undergo clinical, instrumental and laboratory diagnostics tests during follow-up 
visits at 3 and 12 month ± 2 week after discharge, and telephone interview at 6 month after 
discharge to collect information on health status, outcomes and treatment adjustments. 
The study protocol does not provide for a single way for patients managing. If any 
cardiovascular abnormalities or other disturbances found 3 months after discharge, the 
therapy carried out.  
At the visit of 3 and 12 months, the patient is interviewed (complaints, data of the 
epidemiological and medical history), clinical examination, anthropometry, measurement 
of temperature, heart rate, blood pressure, oxygen saturation, dyspnea, myalgia are  
performed. Based on the data obtained, the diagnosis is specified (arterial hypertension, 
coronary artery disease, arrhythmias, obstructive pulmonary disease, asthma, obesity, 
metabolic syndrome, diabetes mellitus, obliterating atherosclerosis and others); the basic 
therapy is adjusted. Each patient undergoes electrocardiography, general and biochemical 
blood tests, microalbuminuria test. Lungs CT, echocardiography with myocardial strain 
assessment, six-minute walk test, assessment of symptoms of stress, anxiety and depressive 
disorders (PSS-10 GAD7, PHQ9, respectively) are performed. According to diagnosis, 
patients are divided into groups. Examination at visits of patients in 12 months after 
discharge is carried out according to the approved examination plan in groups. During the 
observation, the incidence of adverse cardio-cerebral events (MACCE) and the prognostic 
value of the structural and functional parameters of the myocardium and blood vessels will 
be assessed.