Dysautonomia in Patients Post COVID-19 Infection

NCT ID: NCT04716465

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-19

Study Completion Date

2023-01-31

Brief Summary

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The aim for this study is further to elucidate the presence of dysautonomia in post-covid-19 patients, by evaluating heart rate variability.

Detailed Description

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The COVID-19 pandemic is currently a serious global public health concern. This disease is caused by a novel coronavirus which was first discovered in Wuhan, China in 2019 and later spread rapidly throughout the world. Symptoms of the disease can manifest as fever, cough, encephalitis, myalgia, fatigue, muscle weakness, arthralgia, anosmia, and impairment in other bodily functions in the acute phase. In 17% to 67% of cases, COVID-19 patients will develop acute respiratory distress syndrome (ARDS) and critical illness. Besides the impact on the respiratory system, coronaviruses have an effect on other systems including the central nervous system, cardiovascular system, musculoskeletal system, and gastrointestinal system.

Potential long-term secondary effects on the musculoskeletal system such as muscle weakness, decreased muscle mass, and myopathies have been brought under attention. Persisting symptoms in patients recovered from COVID-19 infection are frequently a complaint with at least 1 symptom, particularly fatigue and dyspnea. In recent papers, the authors commented on the potential role of dysautonomia in the post-covid-19 entity related to microangiopathy and endothelial injury. Such lesions were already reported in brain biopsy samples of severe COVID-19.

Therefore, the aim of this study is further to elucidate the presence of dysautonomia in post-covid-19 patients, by evaluating heart rate variability.

Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Covid-19 infected patients

In this study male and female patients who were previously infected with covid-19 (symptomatic and asymptomatic) will be included. Patients will only be eligible if they had a positive covid-19 test before inclusion in the study. More specifically, only patients who had a positive COVID-19 test 2 to 8 weeks before study inclusion are eligible.

Dysautonomia

Intervention Type OTHER

Indicators of dysautonomia

Interventions

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Dysautonomia

Indicators of dysautonomia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosed covid-19 infection that took place 2-8 weeks before study inclusion.
* Cognitive and language functioning enabling coherent communication between the researcher and the participant.
* French-or Dutch speaking persons.

Exclusion Criteria

* Covid-19 infection \> 8 weeks ago.
* The presence of one or more coexisting conditions known to affect HRV analysis (including but not limited to atrial fibrillation, numerous atrial or ventricular extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or hepatic failure, and diabetes mellitus)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moens Maarten

OTHER

Sponsor Role lead

Responsible Party

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Moens Maarten

investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Marc Schiltz, MD

Role: CONTACT

+32 2 477 60 20

Facility Contacts

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Marc Schiltz, MD

Role: primary

+32 2 477 60 20

Other Identifiers

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DYSCO

Identifier Type: -

Identifier Source: org_study_id

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