Mechanisms for Atrial Fibrillation in Obstructive Sleep Apnea

NCT ID: NCT06465134

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-05-31

Brief Summary

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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

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Conditions

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Atrial Fibrillation Obstructive Sleep Apnea Hypertension Autonomic Dysfunction Arterial Stiffness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients scheduled for AF ablation or cardioversion

No intervention

Intervention Type OTHER

There is no intervention

Interventions

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No intervention

There is no intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Auxologico Italiano

OTHER

Sponsor Role collaborator

University of Trieste

OTHER

Sponsor Role collaborator

Danderyd Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristina Lundwall, MD PhD

Role: PRINCIPAL_INVESTIGATOR

KAROLINSKA INSTITUTE, DANDERYD HOSPITAL

Gianfranco Parati, Professor

Role: PRINCIPAL_INVESTIGATOR

Istituto Auxologico Italiano

Locations

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San Luca Hospital

Milan, , Italy

Site Status RECRUITING

Cattinara Hospital

Trieste, , Italy

Site Status NOT_YET_RECRUITING

Danderyd Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Italy Sweden

Central Contacts

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Kristina Lundwall, MD PhD

Role: CONTACT

+46731589999

Gianfranco Parati, Professor

Role: CONTACT

Facility Contacts

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Gianfranco Parati, Professor

Role: primary

Kristina Lundwall, MD PhD

Role: backup

+46731589999

Andrea Grillo, MD PhD

Role: primary

Kristina Lundwall, MD PhD

Role: backup

+46731589999

Kristina Lundwall, MD PhD

Role: primary

+46731589999

Kambiz Shahgaldi, Assoc prof

Role: backup

Other Identifiers

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KAROLINSKA INSTITUTE, DANDERYD

Identifier Type: -

Identifier Source: org_study_id

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