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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06465134
Other study ID # KAROLINSKA INSTITUTE, DANDERYD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2023
Est. completion date May 2026

Study information

Verified date March 2024
Source Danderyd Hospital
Contact Kristina Lundwall, MD PhD
Phone +46731589999
Email kristina.lundwall@regionstockholm.se
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date May 2026
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Other:
No intervention
There is no intervention

Locations

Country Name City State
Italy San Luca Hospital Milan
Italy Cattinara Hospital Trieste
Sweden Danderyd Hospital Stockholm

Sponsors (3)

Lead Sponsor Collaborator
Danderyd Hospital Istituto Auxologico Italiano, University of Trieste

Countries where clinical trial is conducted

Italy,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to recurrence of AF measured on 7 days electrocardiography at month 3, 6, 12 Recurrence of atrial fibrillation after AF ablation or cardioversion one year
Secondary 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 baseline measurements
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