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

Not yet recruiting

• Conditions: Cardiac Complexes, Premature; Atrial Fibrillation
• Interventions: Device: Single night downgraded home polygraphy

• Registration Number: NCT05347953
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

Brief 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

Detailed 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.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-25
• Last Update Submitted: 2022-04-25
• Study First Posted: 2022-04-27
• Last Update Posted: 2022-04-27
• Study Start: 2022-06-01
• Primary Completion: 2023-06-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single arm	Single night downgraded home polygraphy	Patients with self-reported symptoms of positional dependent palpitations

Primary Outcome Measures

Name	Time	Method
Arrhythmia per body position	1 night recording	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.

Trial Locations

Locations (1)

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands