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Clinical Trials/NCT05347953
NCT05347953
Not Yet Recruiting
N/A

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

Catharina Ziekenhuis Eindhoven1 site in 1 country100 target enrollmentJune 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cardiac Complexes, Premature
Sponsor
Catharina Ziekenhuis Eindhoven
Enrollment
100
Locations
1
Primary Endpoint
Arrhythmia per body position
Status
Not Yet Recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
September 1, 2024
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Catharina Ziekenhuis Eindhoven
Responsible Party
Principal Investigator
Principal Investigator

Maarten van den Broek

JLPM van den Broek, MD

Catharina Ziekenhuis Eindhoven

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Arrhythmia per body position

Time Frame: 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.

Study Sites (1)

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