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

April 2, 2024 updated by: Polish Mother Memorial Hospital Research Institute
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prognosis in patients who have recovered from COVID-19
Time Frame: 12 months after inclusion in the study
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Review of selected laboratory tests in patients who have recovered from COVID-19
Time Frame: 12 months after inclusion in the study
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
Time Frame: 12 months after inclusion in the study
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
Time Frame: 12 months after inclusion in the study
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
Time Frame: 12 months after inclusion in the study
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
Time Frame: 12 months after inclusion in the study
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
Time Frame: 12 months after inclusion in the study
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Polish Mother Memorial Hospital Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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