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Mechanisms for Atrial Fibrillation in Obstructive Sleep Apnea

Mechanisms for Incident and Recurrent Atrial Fibrillation in Patients With Obstructive Sleep Apnea; AF - Milano Trieste Stockholm

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06465134
Acronym
AF-MiTriSto
Enrollment
300
Registered
2024-06-18
Start date
2023-11-01
Completion date
2026-05-31
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Stiffness, Atrial Fibrillation, Autonomic Dysfunction, Hypertension, Obstructive Sleep Apnea

Brief 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. 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.

Interventions

OTHERNo intervention

There is no intervention

Sponsors

Istituto Auxologico Italiano
CollaboratorOTHER
University of Trieste
CollaboratorOTHER
Danderyd Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients \>18 years scheduled for AF ablation or cardioversion

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to recurrence of AF measured on 7 days electrocardiography at month 3, 6, 12one yearRecurrence of atrial fibrillation after AF ablation or cardioversion

Secondary

MeasureTime frameDescription
aortic stiffness measured by tonometry; pulse wave velocity (m/s)baseline measurementsmeasured aortic stiffness (measured as pulse wave velocity in m/s) in subjects with OSA compared to those without OSA in the cohort

Countries

Italy, Sweden

Contacts

Primary ContactKristina Lundwall, MD PhD
kristina.lundwall@regionstockholm.se+46731589999
Backup ContactGianfranco Parati, Professor
parati@auxologico.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026