Mechanisms for Atrial Fibrillation in Obstructive Sleep Apnea

Recruiting

• Conditions: Obstructive Sleep Apnea; Autonomic Dysfunction; Hypertension; Arterial Stiffness; Atrial Fibrillation

• Registration Number: NCT06465134
• Lead Sponsor: Danderyd Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-18
• Primary Completion: 2025-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to recurrence of AF measured on 7 days electrocardiography at month 3, 6, 12	one year	Recurrence of atrial fibrillation after AF ablation or cardioversion

Secondary Outcome Measures

Name	Time	Method
aortic stiffness measured by tonometry; pulse wave velocity (m/s)	baseline measurements	measured aortic stiffness (measured as pulse wave velocity in m/s) in subjects with OSA compared to those without OSA in the cohort

Trial Locations

Locations (3)

San Luca Hospital; 🇮🇹 Milan, Italy

Cattinara Hospital; 🇮🇹 Trieste, Italy

Danderyd Hospital; 🇸🇪 Stockholm, Sweden