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

NCT ID: NCT04828629

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-23
• Study Completion Date: 2025-01-01

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.

Conditions

Covid19; Heart Failure

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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 tests

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polish Mother Memorial Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agata Bielecka-Dabrowa

Role: STUDY_CHAIR

Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, PMMHRI

Maciej Banach

Role: STUDY_CHAIR

Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, PMMHRI

Locations

Heart Failure Unit; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute

Lodz, Polska, Poland

Countries

Poland

References

Gryglewska-Wawrzak K, Sakowicz A, Banach M, Bytyci I, Bielecka-Dabrowa A. Diagnostic Usefulness of Spiroergometry and Risk Factors of Long COVID in Patients with Normal Left Ventricular Ejection Fraction. J Clin Med. 2023 Jun 20;12(12):4160. doi: 10.3390/jcm12124160.

Reference Type: DERIVED

PMID: 37373853 (View on PubMed)

Gryglewska-Wawrzak K, Sakowicz A, Banach M, Maciejewski M, Bielecka-Dabrowa A. Factors of Persistent Limited Exercise Tolerance in Patients after COVID-19 with Normal Left Ventricular Ejection Fraction. Biomedicines. 2022 Dec 15;10(12):3257. doi: 10.3390/biomedicines10123257.

Reference Type: DERIVED

PMID: 36552013 (View on PubMed)

Other Identifiers

PMMHRI-BCO.75/2020

Identifier Type: -

Identifier Source: org_study_id