Clinical trial NCT06465134: Mechanisms for Atrial Fibrillation in Obstructive Sleep Apnea
Official title: Mechanisms for Incident and Recurrent Atrial Fibrillation in Patients With Obstructive Sleep Apnea; AF - Milano Trieste Stockholm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Obstructive Sleep Apnea
Hypertension
Autonomic Dysfunction
Arterial Stiffness
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Istituto Auxologico Italiano
name: University of Trieste
First posted: 2024-06-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to recurrence of AF measured on 7 days electrocardiography at month 3, 6, 12
timeFrame: one year
Secondary outcomes:
measure: aortic stiffness measured by tonometry; pulse wave velocity (m/s)
timeFrame: baseline measurements
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Luca Hospital
city: Trieste
country: Italy
facility: Cattinara Hospital
city: Stockholm
country: Sweden
facility: Danderyd Hospital
Study officials:
affiliation: KAROLINSKA INSTITUTE, DANDERYD HOSPITAL
name: Kristina Lundwall, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Auxologico Italiano
name: Gianfranco Parati, Professor
role: PRINCIPAL_INVESTIGATOR
References: