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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01796080
First received: February 18, 2013
Last updated: December 20, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ECG-derived myocardial de- and repolarization times [ Time Frame: 20 seconds ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01796080     History of Changes
Other Study ID Numbers: PAF_V1.1 (05.07.2012)
Study First Received: February 18, 2013
Last Updated: December 20, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014