Mechanisms for Atrial Fibrillation in Obstructive Sleep Apnea (AF-MiTriSto)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Atrial Fibrillation; Obstructive Sleep Apnea; Autonomic Dysfunction; Arterial Stiffness
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Kristina Lundwall, MD PhD; Phone Number: +46731589999; Email: kristina.lundwall@regionstockholm.se
• Study Contact Backup: Name: Gianfranco Parati, Professor; Email: parati@auxologico.it

Study Locations

• Italy
  • Milan, Italy, 20145
    • Recruiting
    • San Luca Hospital
    • Contact: Kristina Lundwall, MD PhD; Phone Number: +46731589999; Email: kristina.lundwall@regionstockholm.se
    • Contact: Gianfranco Parati, Professor; Email: parati@auxologico.it
  • Trieste, Italy
    • Not yet recruiting
    • Cattinara Hospital
    • Contact: Kristina Lundwall, MD PhD; Phone Number: +46731589999; Email: kristina.lundwall@regionstockholm.se
    • Contact: Andrea Grillo, MD PhD; Email: andr.grillo@gmail.com
• Sweden
  • Stockholm, Sweden, 182 88
    • Recruiting
    • Danderyd Hospital
    • Contact: Kristina Lundwall, MD PhD; Phone Number: +46731589999; Email: kristina.lundwall@regionstockholm.se
    • Contact: Kambiz Shahgaldi, Assoc prof; Email: kambiz.shahgaldi@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Patients scheduled for AF ablation or cardioversion	Other: No intervention; There is no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Danderyd Hospital
• Collaborators: University of Trieste; Istituto Auxologico Italiano
• Investigators: Principal Investigator: Kristina Lundwall, MD PhD, KAROLINSKA INSTITUTE, DANDERYD HOSPITAL; Principal Investigator: Gianfranco Parati, Professor, Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Arrhythmias, Cardiac; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Atrial Fibrillation; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: KAROLINSKA INSTITUTE, DANDERYD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No