Covid19NCT04828629

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

An observational study of Covid19 and Heart Failure, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19, Heart Failure
What is being tested?: Diagnostic tests
How many people: 100 participants
Where: 1 sitePoland
Study dates: 23 Dec 2020to 1 Jan 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

severe hypertension;
unstable angina;
acute pulmonary embolism;
decompensated heart failure;
recent myocardial infarction;
unstable heart rhythm disturbances;

Show all 24Show fewer

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

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

Other trials in Poland

About this study

Read the 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
Being tested: Diagnostic tests
Medical subject headings: COVID-19, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diagnostic testsDiagnostic 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.

Study groups in NCT04828629
Study group	Role	What they receive
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 Receives: Diagnostic Test: Diagnostic tests

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months after inclusion in the study

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 12 months after inclusion in the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Dec 20201 Jan 2025

First posted2 Apr 2021
Study start23 Dec 2020
Primary completion1 Dec 2024 (estimated)
Study completion1 Jan 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Covid19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04828629
Sponsor's protocol ID: PMMHRI-BCO.75/2020
Status last verified: Nov 2023
First submitted: 12 Mar 2021
Last updated: 3 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 37373853
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.
PubMed 36552013

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Complications and the Influence of COVID-19 on Myocardial Function and Exercise Capacity
ClinicalTrials.gov ID: NCT04828629
Acronym / sponsor ID: PMMHRI-BCO.75/2020
Conditions: Covid19, Heart Failure
Study type: Observational
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Polish Mother Memorial Hospital Research InstituteUniversity, hospital or other
Study start: 23 Dec 2020 (actual)
Primary completion: 1 Dec 2024 (estimated)
Study completion: 1 Jan 2025 (estimated)
First posted: 2 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Identification of prognostic factors in patients who have recovered from COVID-19	–	Diagnostic Test: Diagnostic testsSelected prognosis factors will be analyzed in patients who have recovered from COVID-19

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (24 listed)

severe hypertension;
unstable angina;
acute pulmonary embolism;
decompensated heart failure;
recent myocardial infarction;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diagnostic testsSelected 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.	Diagnostic test	Identification of prognostic factors in patients who have recovered from COVID-19

Primary outcome

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.

6 secondary outcomes

Review of selected laboratory tests in patients who have recovered from COVID-19
Time frame: 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
Review of selected Holter ECG monitoring data in patients who have recovered from COVID-19
Time frame: 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
Review of parameters in the spiroergometric study in patients who have recovered from COVID-19
Time frame: 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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
Derived from this study: PubMed 37373853Gryglewska-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.
Derived from this study: PubMed 36552013Gryglewska-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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Agata Bielecka-Dabrowa study chair

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

Maciej Banach study chair

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Heart Failure, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prognosis in patients who have recovered from COVID-19 (time frame: 12 months after inclusion in the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04828629, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.