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The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation

Primary Purpose

Patients With Paroxysmal Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Mueller manoeuvre
Inspiratory threshold
Expiratory apnoea
Steady state normal breathing
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Patients With Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Age 18-75 years
  • History of ECG-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm
  • Informed consent

Exclusion criteria:

  • Mental or physical disability precluding informed consent or compliance with the protocol
  • Amiodarone or Dronedarone medication
  • Previous radiofrequency ablation for atrial fibrillation
  • Severe structural heart disease

Sites / Locations

  • University Hospital Zurich, Division of Pneumology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Mueller manoeuvre

Inspiratory threshold

Expiratory apnoea

Steady state normal breathing

Arm Description

Mueller manoeuvre lasting for 20 seconds

One continuous inspiration through an inspiratory threshold load for 20 seconds

Expiratory apnoea (without respiratory effort) lasting for 20 seconds

Steady state normal breathing for 20 seconds

Outcomes

Primary Outcome Measures

Number of subjects with premature myocardial contractions and/or atrial fibrillation

Secondary Outcome Measures

ECG-derived myocardial de- and repolarization times

Full Information

First Posted
February 18, 2013
Last Updated
December 20, 2013
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01796080
Brief Title
The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation
Official Title
The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In this randomised controlled cross-over study we will investigate whether intrathoracic pressure changes induced by simulated obstructive apnoea and hypopnoea trigger premature supraventricular and ventricular contractions as well as atrial fibrillation in patients with paroxysmal atrial fibrillation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mueller manoeuvre
Arm Type
Active Comparator
Arm Description
Mueller manoeuvre lasting for 20 seconds
Arm Title
Inspiratory threshold
Arm Type
Active Comparator
Arm Description
One continuous inspiration through an inspiratory threshold load for 20 seconds
Arm Title
Expiratory apnoea
Arm Type
Active Comparator
Arm Description
Expiratory apnoea (without respiratory effort) lasting for 20 seconds
Arm Title
Steady state normal breathing
Arm Type
Sham Comparator
Arm Description
Steady state normal breathing for 20 seconds
Intervention Type
Other
Intervention Name(s)
Mueller manoeuvre
Intervention Type
Other
Intervention Name(s)
Inspiratory threshold
Intervention Type
Other
Intervention Name(s)
Expiratory apnoea
Intervention Type
Other
Intervention Name(s)
Steady state normal breathing
Primary Outcome Measure Information:
Title
Number of subjects with premature myocardial contractions and/or atrial fibrillation
Time Frame
20 seconds
Secondary Outcome Measure Information:
Title
ECG-derived myocardial de- and repolarization times
Time Frame
20 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Age 18-75 years History of ECG-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm Informed consent Exclusion criteria: Mental or physical disability precluding informed consent or compliance with the protocol Amiodarone or Dronedarone medication Previous radiofrequency ablation for atrial fibrillation Severe structural heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm Kohler, Prof MD
Organizational Affiliation
University Hospital Zurich, Division of Pneumology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Pneumology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation

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