Mechanisms for Atrial Fibrillation in Obstructive Sleep Apnea

NCT06465134 | Recruiting

• 1 other identifier: KAROLINSKA INSTITUTE, DANDERYD
• Study Type: observational
• Target: 300
• Locations: 2 countries
• Sites: 3

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.

Conditions

Atrial Fibrillation; Obstructive Sleep Apnea; Hypertension; Autonomic Dysfunction; Arterial Stiffness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  baseline measurements

Study Arms (1)

Group 1

Patients scheduled for AF ablation or cardioversion

Other: No intervention

Interventions

No intervention OTHER

There is no intervention

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients at San Luca Hospital Cattinara Hospital Italy, and Danderyd Hospital Sweden are used. Patients with atrial fibrillation scheduled for AF ablation or cardioversion are selected.

You may qualify if:

• Patients \>18 years scheduled for AF ablation or cardioversion

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danderyd Hospital: lead
• Istituto Auxologico Italiano: collaborator
• University of Trieste: collaborator

Study Sites (3)

San Luca Hospital

Milan, 20145, Italy

RECRUITING

Cattinara Hospital

Trieste, Italy

NOT YET RECRUITING

Danderyd Hospital

Stockholm, 182 88, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples and urine

MeSH Terms

Conditions

Atrial Fibrillation; Sleep Apnea, Obstructive; Hypertension; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Autonomic Nervous System Diseases

Study Officials

• Kristina Lundwall, MD PhD

  KAROLINSKA INSTITUTE, DANDERYD HOSPITAL

  PRINCIPAL INVESTIGATOR

• Gianfranco Parati, Professor

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Lundwall, MD PhD

CONTACT

+46731589999; kristina.lundwall@regionstockholm.se

Gianfranco Parati, Professor

CONTACT

parati@auxologico.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: June 18, 2024
• Study Start: November 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: June 18, 2024

Record last verified: 2024-03

Locations

SE (1); IT (2)