Mechanisms for Atrial Fibrillation in Obstructive Sleep Apnea

Hypertension Clinical Trial

— AF-MiTriSto  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06465134
• Other study ID #: KAROLINSKA INSTITUTE, DANDERYD
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Apnea
• Arterial Stiffness
• Atrial Fibrillation
• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Hypertension
• Obstructive Sleep Apnea
• Primary Dysautonomias
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

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