Patients With Paroxysmal Atrial FibrillationNCT01796080
The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation
A study testing Mueller manoeuvre, Inspiratory threshold and Expiratory apnoea in people with Patients With Paroxysmal Atrial Fibrillation, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Paroxysmal Atrial Fibrillation
- What is being tested?
- Mueller manoeuvre, Inspiratory threshold and Expiratory apnoea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- History of ECG-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Pneumology
Zurich, Canton of Zurich, 8091
About this study
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.
- Being tested
- Mueller manoeuvre, Inspiratory threshold, Expiratory apnoea, Steady state normal breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mueller manoeuvreOther
Inspiratory thresholdOther
Expiratory apnoeaOther
Steady state normal breathingOther
| Study group | Role | What they receive |
|---|---|---|
| Mueller manoeuvre | Active comparator | Mueller manoeuvre lasting for 20 seconds Receives: Other: Mueller manoeuvre |
| Inspiratory threshold | Active comparator | One continuous inspiration through an inspiratory threshold load for 20 seconds Receives: Other: Inspiratory threshold |
| Expiratory apnoea | Active comparator | Expiratory apnoea (without respiratory effort) lasting for 20 seconds Receives: Other: Expiratory apnoea |
| Steady state normal breathing | Sham comparator | Steady state normal breathing for 20 seconds Receives: Other: Steady state normal breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with premature myocardial contractions and/or atrial fibrillation
Measured: 20 seconds
Secondary outcomes (1)
ECG-derived myocardial de- and repolarization times
Measured: 20 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malcolm Kohler, Prof MD, Principal investigator, University Hospital Zurich, Division of Pneumology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796080
- Sponsor's protocol ID
- PAF_V1.1 (05.07.2012)
- Status last verified
- Dec 2013
- First submitted
- 18 Feb 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01796080
- Acronym / sponsor ID
- PAF_V1.1 (05.07.2012)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mueller manoeuvre | Active comparator | Other: Mueller manoeuvreMueller manoeuvre lasting for 20 seconds |
| Inspiratory threshold | Active comparator | Other: Inspiratory thresholdOne continuous inspiration through an inspiratory threshold load for 20 seconds |
| Expiratory apnoea | Active comparator | Other: Expiratory apnoeaExpiratory apnoea (without respiratory effort) lasting for 20 seconds |
| Steady state normal breathing | Sham comparator | Other: Steady state normal breathingSteady state normal breathing for 20 seconds |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years
- History of ECG-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm
- Informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mueller manoeuvre | Other | Mueller manoeuvre |
| Inspiratory threshold | Other | Inspiratory threshold |
| Expiratory apnoea | Other | Expiratory apnoea |
| Steady state normal breathing | Other | Steady state normal breathing |
Primary outcome
Number of subjects with premature myocardial contractions and/or atrial fibrillation
Time frame: 20 seconds
1 secondary outcome
ECG-derived myocardial de- and repolarization times
Time frame: 20 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm Kohler, Prof MD principal investigator
University Hospital Zurich, Division of Pneumology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mueller manoeuvre, Inspiratory threshold and Expiratory apnoea in people with Patients With Paroxysmal Atrial Fibrillation, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with premature myocardial contractions and/or atrial fibrillation (time frame: 20 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2013.