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Clinical Trials/NCT06465134
NCT06465134
Recruiting
Not Applicable

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

Danderyd Hospital3 sites in 2 countries300 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Danderyd Hospital
Enrollment
300
Locations
3
Primary Endpoint
Time to recurrence of AF measured on 7 days electrocardiography at month 3, 6, 12
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
May 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Danderyd Hospital
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • aortic stiffness measured by tonometry; pulse wave velocity (m/s)(baseline measurements)

Study Sites (3)

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