Complications and the Influence of COVID-19 on Myocardial Function and Exercise Capacity

Heart Failure Clinical Trial

Official title:

Complications and the Influence of COVID-19 on Myocardial Function and Exercise Capacity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04828629
• Other study ID #: PMMHRI-BCO.75/2020
• Status: Active, not recruiting
• Start date: December 23, 2020
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2023
• Source: Polish Mother Memorial Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Heart Failure

Intervention

Diagnostic Test:
• Diagnostic tests
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.

Locations

Country	Name	City	State
Poland	Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute	Lódz	Polska

Sponsors (1)

Lead Sponsor	Collaborator
Polish Mother Memorial Hospital Research Institute

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognosis in patients who have recovered from COVID-19	A control hospitalization will be conducted with patients. The same prognostic factors will be analyzed: physical examination, symptoms, co-morbidities, treatment applied, results of selected laboratory tests, lung imaging (X-ray or computed tomography) selected electrocardiographic (ECG) and echocardiographic data, parameters in the spiroergometric study, body mass analysis.	12 months after inclusion in the study
Secondary	Review of selected laboratory tests in patients who have recovered from COVID-19	Diagnostic blood samples will be collected from each patient: N-terminal pro b-type natriuretic peptide (NT-proBNP) and high sensitive cardiac Troponin T (hsTnT), the alanine aminotransferase (ALT) and aspartate transaminase (ASP), creatinine, glomerular filtration rate (GFR) estimate by Modification of Diet in Renal Disease (MDRD) parameters, inflammatory cytokine [C-reactive protein (CRP)], glucose level, lipoprotein profile: low density lipoprotein (LDL), high density lipoprotein (HDL), triglycerides (TG) and total cholesterol (TC). Also, the amount of hemoglobin will be performed.	12 months after inclusion in the study
Secondary	The imaging of pulmonary changes in patients who have recovered from COVID-19	Chest X-ray or lung computed tomography will be performed.	12 months after inclusion in the study
Secondary	Review of selected Holter ECG monitoring data in patients who have recovered from COVID-19	Analysis of average heart rate, ST segment abnormality (elevation or depression), the presence of: atrioventricular delay (AV block), bundle branch block, supraventricular and ventricular extrasystoles, atrial fibrillation (AF).	12 months after inclusion in the study
Secondary	Review of selected echocardiographic data in patients who have recovered from COVID-19	Measurement of left ventricular (LV) volume and ejection fraction (EF), left atrial (LA) volume, LA volume index (LAVi), maximal early (E) and late (A) transmitral velocities, ratio of early transmitral peak velocity to early diastolic peak annular velocity (E/E'), early diastolic (E'), late diastolic (A') mitral annular myocardial velocity of the left ventricle, LAVi/A', tricuspid annular plane systolic excursion (TAPSE).	12 months after inclusion in the study
Secondary	Review of parameters in the spiroergometric study in patients who have recovered from COVID-19	Forced vital capacity (FVC),forced expiratory volume in one second (FEV1), FEV1/FVC ratio, VO2max (represents the maximal achievable level of oxidative metabolism involving large muscle groups), ventilatory exchange (VE), oxygen uptake (VO2), CO2 expenditure (VCO2), respiratory exchange ratio (RER), anaerobic threshold (AT), oxygen uptake at anaerobic threshold (VO2 AT), the minute ventilation/carbon dioxide production slope (VE/VCO2 slope) will be performed.	12 months after inclusion in the study
Secondary	Body mass analysis in patients who have recovered from COVID-19	Body composition measurement will be conducted using bioelectrical impedance analysis (BIA). Fat mass (FM) and fat-free mass (FFM), total body water (TBW), extra-cellular (ECW) and intra-cellular (ICW) water, ECW/TBWx100% will be measured.	12 months after inclusion in the study