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

NCT04828629 | Unknown

• 1 other identifier: PMMHRI-BCO.75/2020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Review of selected laboratory tests in patients who have recovered from COVID-19

  12 months after inclusion in the study

• The imaging of pulmonary changes in patients who have recovered from COVID-19

  12 months after inclusion in the study

• Review of selected Holter ECG monitoring data in patients who have recovered from COVID-19

  12 months after inclusion in the study

• Review of selected echocardiographic data in patients who have recovered from COVID-19

  12 months after inclusion in the study

• Review of parameters in the spiroergometric study in patients who have recovered from COVID-19

  12 months after inclusion in the study

Study Arms (1)

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

Interventions

Diagnostic tests 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.

Identification of prognostic factors in patients who have recovered from COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Polish Mother Memorial Hospital Research Institute: lead

Study Sites (1)

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

Lodz, Polska, 93-338, Poland

Location

Related Publications (2)

• 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.

  PMID: 37373853 DERIVED

• 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.

  PMID: 36552013 DERIVED

MeSH Terms

Conditions

COVID-19; Heart Failure

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: April 2, 2021
• Study Start: December 23, 2020
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2023-11

Locations

PL (1)