Atrial FibrillationAF-MiTriStoNCT06465134
Mechanisms for Atrial Fibrillation in Obstructive Sleep Apnea
An observational study of Atrial Fibrillation and Obstructive Sleep Apnea, run by Danderyd Hospital at 3 sites in 2 countries.
Trial summary
Atrial fibrillation (AF) is the most common rhythm disorder and involves an increased risk of cardiovascular disease and death, impaired quality of life and a high proportion of healthcare consumption. An important risk factor is obstructive sleep apnea (OSA). However, it is not fully understood why OSA induces AF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Obstructive Sleep Apnea, Hypertension
- How many people
- 300 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Nov 2023to May 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at San Luca Hospital Cattinara Hospital Italy, and Danderyd Hospital Sweden are used. Patients with atrial fibrillation scheduled for AF ablation or cardioversion are selected.
Who may be able to join
- Patients >18 years scheduled for AF ablation or cardioversion
Who cannot join
- diagnosis of AF for more than 7 years
- previous cardiac surgery including AF ablation
- severe valvular heart disease
- diagnosed structural heart disease
- systolic function in sinus rhythm <50%.
- severe hypertensive heart disease or known hypertrophic heart disease (amyloidosis, hereditary hypertrophic heart disease)
- invalidating chronic diseases imaging material on echocardiography not of sufficient quality.
Trial locations and contacts
3 sites in 2 countries.
Gianfranco Parati, Professor contact
3 sites in 2 countries
Italy2 sites, 2 recruiting
- Recruiting
San Luca Hospital
Milan, 20145
Gianfranco Parati, Professor, parati@auxologico.it
Kristina Lundwall, MD PhD, +46731589999, kristina.lundwall@regionstockholm.se
- Not yet recruiting
Cattinara Hospital
Trieste
Andrea Grillo, MD PhD, andr.grillo@gmail.com
Kristina Lundwall, MD PhD, +46731589999, kristina.lundwall@regionstockholm.se
Sweden1 site, 1 recruiting
- Recruiting
Danderyd Hospital
Stockholm, 182 88
Kristina Lundwall, MD PhD, +46731589999, kristina.lundwall@regionstockholm.se
Kambiz Shahgaldi, Assoc prof, kambiz.shahgaldi@regionstockholm.se
About this study
Official title: Mechanisms for Incident and Recurrent Atrial Fibrillation in Patients With Obstructive Sleep Apnea; AF - Milano Trieste Stockholm
Atrial fibrillation (AF) is the most common rhythm disorder and involves an increased risk of cardiovascular disease and death, impaired quality of life and a high proportion of healthcare consumption. An important risk factor is obstructive sleep apnea (OSA). However, it is not fully understood why OSA induces AF. It may be due to a proinflammatory state, sympathetic activation and acute changes in blood pressure during apnéas, but few studies are performed. Hypertension with its coherent arterial stiffness is related to all these factors, is common in OSA, and is the most common cause of AF. The cause of AF in hypertensive subjects is believed due to a pressure overloaded left heart, with dilation and fibrosis of the left atrium, promoting the development of AF. Hypertension and arterial stiffness can thus be important triggering factors for AF in OSA.
In this project, teh investigators investigate the occurrence of OSA in AF patients. Furthermore, underlying mechanisms for the development and recurrence of AF after intervention in OSA patients are investigated.
300 patients scheduled for AF ablation or cardioversion are invited and examined with sleep registration, 24h blood pressure, aortic stiffness measurement, test of autonomic function, echocardiography, ECG and labs. The patients are followed at months 3, 6 and 12 with 7 days ECG for recurrence. The aim is to give insights into the need for screening for OSA in patients with AF. The study also aim at enabling preventive treatment through better understanding of underlying treatable mechanisms. The results are believed to lead to fewer new AFs, as well as fewer AF recurrences in patients with OSA.
- Conditions
- Atrial Fibrillation, Obstructive Sleep Apnea, Hypertension, Autonomic Dysfunction, Arterial Stiffness
- Being tested
- No intervention
- Medical subject headings
- Atrial Fibrillation, Sleep Apnea, Obstructive, Hypertension, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients scheduled for AF ablation or cardioversion Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrence of AF measured on 7 days electrocardiography at month 3, 6, 12
Recurrence of atrial fibrillation after AF ablation or cardioversion
Measured: one year
Secondary outcomes (1)
aortic stiffness measured by tonometry; pulse wave velocity (m/s)
measured aortic stiffness (measured as pulse wave velocity in m/s) in subjects with OSA compared to those without OSA in the cohort
Measured: baseline measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Nov 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Auxologico Italiano, University of Trieste
- Responsible party
- Sponsor
- Investigators
- Kristina Lundwall, MD PhD, Principal investigator, KAROLINSKA INSTITUTE, DANDERYD HOSPITALGianfranco Parati, Professor, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465134
- Sponsor's protocol ID
- KAROLINSKA INSTITUTE, DANDERYD
- Acronym
- AF-MiTriSto
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms for Incident and Recurrent Atrial Fibrillation in Patients With Obstructive Sleep Apnea; AF - Milano Trieste Stockholm
- ClinicalTrials.gov ID
- NCT06465134
- Acronym / sponsor ID
- AF-MiTriSto / KAROLINSKA INSTITUTE, DANDERYD
- Conditions
- Atrial Fibrillation, Obstructive Sleep Apnea, Hypertension, Autonomic Dysfunction, Arterial Stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- Istituto Auxologico Italiano, University of Trieste
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Jun 2024 (actual)
- 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.
Atrial fibrillation (AF) is the most common rhythm disorder and involves an increased risk of cardiovascular disease and death, impaired quality of life and a high proportion of healthcare consumption. An important risk factor is obstructive sleep apnea (OSA). However, it is not fully understood why OSA induces AF. It may be due to a proinflammatory state, sympathetic activation and acute changes in blood pressure during apnéas, but few studies are performed. Hypertension with its coherent arterial stiffness is related to all these factors, is common in OSA, and is the most common cause of AF. The cause of AF in hypertensive subjects is believed due to a pressure overloaded left heart, with dilation and fibrosis of the left atrium, promoting the development of AF. Hypertension and arterial stiffness can thus be important triggering factors for AF in OSA.
In this project, teh investigators investigate the occurrence of OSA in AF patients. Furthermore, underlying mechanisms for the development and recurrence of AF after intervention in OSA patients are investigated.
300 patients scheduled for AF ablation or cardioversion are invited and examined with sleep registration, 24h blood pressure, aortic stiffness measurement, test of autonomic function, echocardiography, ECG and labs. The patients are followed at months 3, 6 and 12 with 7 days ECG for recurrence. The aim is to give insights into the need for screening for OSA in patients with AF. The study also aim at enabling preventive treatment through better understanding of underlying treatable mechanisms. The results are believed to lead to fewer new AFs, as well as fewer AF recurrences in patients with OSA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No interventionPatients scheduled for AF ablation or cardioversion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at San Luca Hospital Cattinara Hospital Italy, and Danderyd Hospital Sweden are used. Patients with atrial fibrillation scheduled for AF ablation or cardioversion are selected.
Key inclusion criteria (1 listed)
- Patients >18 years scheduled for AF ablation or cardioversion
Key exclusion criteria (7 listed)
- diagnosis of AF for more than 7 years
- previous cardiac surgery including AF ablation
- severe valvular heart disease
- diagnosed structural heart disease
- systolic function in sinus rhythm <50%.
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 |
|---|---|---|
| No interventionThere is no intervention | Other | Group 1 |
Primary outcome
Time to recurrence of AF measured on 7 days electrocardiography at month 3, 6, 12
Time frame: one year
Recurrence of atrial fibrillation after AF ablation or cardioversion
1 secondary outcome
aortic stiffness measured by tonometry; pulse wave velocity (m/s)
Time frame: baseline measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
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.
Gianfranco Parati, Professor contact
Kristina Lundwall, MD PhD principal investigator
KAROLINSKA INSTITUTE, DANDERYD HOSPITAL
Gianfranco Parati, Professor principal investigator
Istituto Auxologico Italiano
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Obstructive Sleep Apnea, run by Danderyd Hospital at 3 sites in 2 countries.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, Sweden. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristina Lundwall, MD PhD (+46731589999, kristina.lundwall@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recurrence of AF measured on 7 days electrocardiography at month 3, 6, 12 (time frame: one year). 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 18 Jun 2024.