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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure; Covid19
• Intervention / Treatment: Diagnostic test: Diagnostic tests

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Poland
  • Polska
    • Łódź, Polska, Poland, 93-338
      • Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Identification of prognostic factors in patients who have recovered from COVID-19; Selected prognosis factors will be analyzed in patients who have recovered from COVID-19

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Polish Mother Memorial Hospital Research Institute
• Investigators: Study Chair: Agata Bielecka-Dabrowa, Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, PMMHRI; Study Chair: Maciej Banach, Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, PMMHRI

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PMMHRI-BCO.75/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No