Pilot study to characterize the autonomic balance and the circadian rhythm in the course of a COVID-19 infection using Holter ECG

• Conditions: I50; Heart failure

• Registration Number: DRKS00029687
• Lead Sponsor: niversitätsklinik für Pneumologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-19
• Study Completion: 2022-10-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

1. Patients in the final isolated stage of SARS-CoV-2 infection
2. Patients with sinus rhythm or patients with paroxysmal atrial fibrillation
3. Patient is able to obtain a Holter ECG
4. Signed Consent Form

Exclusion Criteria

1. Patients with persistent or permanent atrial fibrillation
2. Patients who require permanent atrial pacing an HSM
3. Age < 18 years
4. Pregnancy or lactating
5. State after cardiac transplantation (HTX)
6. Chronic renal failure patients with stages 4 and 5 according to KDOQI
7. Patients with active tumor diseases undergoing chemotherapy/radiation therapy
8. Therapy with topical corticosteroid therapy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collection of reference values of the sympatho-vagal balance as a value of the interaction of parasympathetic (HF) and sympathetic (LF) and parasympathetic activity (R-MSSD)

Secondary Outcome Measures

Name	Time	Method
1) Exploratory data analysis of classic heart rate parameters and their correlation to clinical symptoms/patient diary<br>2) Comparison of sympatho-vagal balance (normal values/healthy (data from OvGU BIO|CONCEPT.ECG library) vs. SARS-CoV-2 in the no longer infectious stage<br>3) Validation of the applicability of the inZHerz (DRKS0002238) circadian profile<br>4) Artifact and security analysis