Clinical trial NCT05347953: Gravitational Arrhythmogenesis Can the Often-heard Symptom of Body Position Dependent Palpitations be Proven
Official title: Gravitational Arrhythmogenesis Can the Often-heard Symptom of Body Position Dependent Palpitations be Proven
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Complexes, Premature
Atrial Fibrillation
Keywords: Body position
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be conducted in outpatients that present with palpitations and a spontaneous self-reported higher prevalence in a certain body position.

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.

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.

Primary outcomes:
measure: Arrhythmia per body position
timeFrame: 1 night recording
Secondary outcomes:
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: JLPM van den Broek
role: PRINCIPAL_INVESTIGATOR
References: