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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01796080
First Posted: February 21, 2013
Last Update Posted: December 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose
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.

Condition Intervention
Patients With Paroxysmal Atrial Fibrillation Other: Mueller manoeuvre Other: Inspiratory threshold Other: Expiratory apnoea Other: Steady state normal breathing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Number of subjects with premature myocardial contractions and/or atrial fibrillation [ Time Frame: 20 seconds ]

Secondary Outcome Measures:
  • ECG-derived myocardial de- and repolarization times [ Time Frame: 20 seconds ]

Enrollment: 45
Study Start Date: October 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mueller manoeuvre
Mueller manoeuvre lasting for 20 seconds
Other: Mueller manoeuvre
Active Comparator: Inspiratory threshold
One continuous inspiration through an inspiratory threshold load for 20 seconds
Other: Inspiratory threshold
Active Comparator: Expiratory apnoea
Expiratory apnoea (without respiratory effort) lasting for 20 seconds
Other: Expiratory apnoea
Sham Comparator: Steady state normal breathing
Steady state normal breathing for 20 seconds
Other: Steady state normal breathing

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796080


Locations
Switzerland
University Hospital Zurich, Division of Pneumology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Malcolm Kohler, Prof MD University Hospital Zurich, Division of Pneumology
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01796080     History of Changes
Other Study ID Numbers: PAF_V1.1 (05.07.2012)
First Submitted: February 18, 2013
First Posted: February 21, 2013
Last Update Posted: December 23, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Atrial Fibrillation
Sleep Apnea, Obstructive
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases