Gravitational Arrhythmogenesis Can the Often-heard Symptom of Body Position Dependent Palpitations be Proven

Atrial Fibrillation Clinical Trial

Official title:

Gravitational Arrhythmogenesis Can the Often-heard Symptom of Body Position Dependent Palpitations be Proven

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05347953
• Other study ID #: NL 81272.100.22
• Status: Not yet recruiting
• Start date: June 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2022
• Source: Catharina Ziekenhuis Eindhoven
• Contact: JLPM van den Broek
• Phone: +31402397000
• Email: maarten.vd.broek[@]catharinaziekenhuis.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to assess the relationship between body position and the occurrence of either atrial or ventricular premature beats and more complex arrhythmia

Description:

Rationale: Palpitations in a certain body position is an often-heard symptom, although there is currently no direct evidence that links body position with arrhythmia. The hypothesis is that arrhythmia is more prevalent in the specific body position that the patient reports to be arrhythmogenic.

Objective: The objective of this study is to assess the relationship between body position and the occurrence of either atrial or ventricular premature beats and more complex arrhythmia (AT, atrial fibrillation (AF), VT) in a population that have a self-reported preferential body position for symptoms.

Study design: Single cohort study. Subjects are recruited from the outpatient clinic. First, they will fill in a short questionnaire regarding their symptoms; second, they will be outfitted with a downgraded polygraphy device, that only monitors body position, and single and/or multi lead ECG for 24 hours. The acquired data will be analyzed at the Catharina Hospital and the Eindhoven University of Technology.

Study population: Outpatients with palpitations and a self-reported higher prevalence in a certain body position that have an indication to undergo Holter monitoring, independent of any previous diagnosis.

Main study parameters/endpoints: The frequency of ectopic beats or onset of complex arrhythmia (n per minute) in the body position that the patient has reported as arrhythmogenic, compared to arrhythmia rate in the other body positions, corrected for time spent per body position.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Palpitations, spontaneously described to occur either predominantly or solely in a certain body position (upright, prone, supine, left or right lateral decubital position).

• Ability to provide informed consent

Exclusion Criteria:

• There are no exclusion criteria for this study.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Single night downgraded home polygraphy
All patients will be outfitted with the ambulatory downgraded polygraphy device (Nox A1, Nox Medical Global, Reykjavik) for 24 hour monitoring. The data exported by the polygraphy device is in European Data Format and will be filtered and annotated using custom MATLAB-software.

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis	Eindhoven

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrhythmia per body position	The frequency of ectopic beats or onset of complex arrhythmia (n per minute) in the body position that the patient has reported as arrhythmogenic, compared to arrhythmia rate in the other body positions, corrected for time spent per body position.	1 night recording