Clinical trial NCT04828629: Complications and the Influence of COVID-19 on Myocardial Function and Exercise Capacity
Official title: Complications and the Influence of COVID-19 on Myocardial Function and Exercise Capacity
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19
Heart Failure
Lead sponsor: Polish Mother Memorial Hospital Research Institute
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The 100 consecutive adult patients (18 years of age or older) hospitalized in the Department of Cardiology and Congenital Heart Diseases of Adults who had recovered from COVID-19 will be included in the study.

Brief summary: The subject of the study is the impact of COVID-19 on the indicators of myocardial efficiency and exercise capacity. As a result of the observed dependencies, it will be possible to start an appropriate diagnostic procedure early, select personalized treatment and develop a model of cardiological care for people with a history of SARS-CoV-2 infection and improve the quality and extend their life.

Detailed description: About 100 adult patients hospitalized in the Department of Cardiology and Congenital Heart Diseases of Adults who had recovered from COVID-19 will be included in the study. Selected prognostic factors will be analyzed, among others: demographic data of the patient, physical examination, symptoms, co-morbidities, results of selected laboratory tests, lung imaging (X-ray or computed tomography) selected electrocardiographic and echocardiographic data, patient's cooperation with the doctor, treatment applied, parameters in the spiroergometric study, body mass analysis. One year after inclusion in the study, a control hospitalization will be performed. The same factors will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Age equal to or older than 18 years
* infection with the SARS-CoV-2 in past medical history
* current hospitalization

Exclusion Criteria:

* severe hypertension;
* unstable angina;
* acute pulmonary embolism;
* decompensated heart failure;
* recent myocardial infarction;
* unstable heart rhythm disturbances;
* acute myocarditis or pericarditis;
* active endocarditis;
* advanced atrioventricular block;
* diagnosis of cardiomyopathy (hypertrophic, dilated, restrictive, peripartum, arrhythmogenic)
* lysosomal storage disorders
* severe hyper- and hypothyroidism
* pregnancy and lactation
* chronic kidney disease (IV, V stadium according to NKF) and dialysis treatment
* documented neoplastic process
* the patient's inability to cooperate and/or provide informed consent to participate in a research
* alcohol and drug abuse
* active autoimmune disease
* treatment using immunosuppressants, cytostatic drugs, glucocorticosteroids, or antiretroviral drugs
* a history of bone marrow transplant or other organ transplant, treatment with blood products within the last 6 months
* active systemic infection
* HBV, HCV or HIV carrier or positive for HbS antigen or antibodies to HCV
* surgery or serious injury within the last month
* patients who did not express their informed consent to participate in the study

Primary outcomes:
measure: Prognosis in patients who have recovered from COVID-19
timeFrame: 12 months after inclusion in the study
Secondary outcomes:
measure: Review of selected laboratory tests in patients who have recovered from COVID-19
timeFrame: 12 months after inclusion in the study
measure: The imaging of pulmonary changes in patients who have recovered from COVID-19
timeFrame: 12 months after inclusion in the study
measure: Review of selected Holter ECG monitoring data in patients who have recovered from COVID-19
timeFrame: 12 months after inclusion in the study
measure: Review of selected echocardiographic data in patients who have recovered from COVID-19
timeFrame: 12 months after inclusion in the study
measure: Review of parameters in the spiroergometric study in patients who have recovered from COVID-19
timeFrame: 12 months after inclusion in the study
measure: Body mass analysis in patients who have recovered from COVID-19
timeFrame: 12 months after inclusion in the study
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute
state: Polska
Study officials:
affiliation: Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, PMMHRI
name: Agata Bielecka-Dabrowa
role: STUDY_CHAIR
affiliation: Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, PMMHRI
name: Maciej Banach
role: STUDY_CHAIR
References: