Understanding how obstructive sleep apnea affects atrial fibrillation
Mechanisms for Incident and Recurrent Atrial Fibrillation in Patients With Obstructive Sleep Apnea; AF - Milano Trieste Stockholm
This study looks at how obstructive sleep apnea might lead to heart rhythm problems in adults who have high blood pressure and are getting treatment for atrial fibrillation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Danderyd Hospital Academic / other |
| Locations | 3 sites (Milan and 2 other locations) |
| Trial ID | NCT06465134 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between obstructive sleep apnea (OSA) and atrial fibrillation (AF), a common heart rhythm disorder. It focuses on understanding the mechanisms by which OSA may contribute to the development of AF, particularly in patients with hypertension and arterial stiffness. The study will involve patients over 18 years old who are scheduled for AF ablation or cardioversion, examining their health conditions and the potential triggers for AF related to OSA. By investigating these connections, the study seeks to shed light on the underlying factors that may lead to AF in patients with OSA.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over 18 years old who are scheduled for atrial fibrillation ablation or cardioversion.
Not a fit: Patients with a diagnosis of atrial fibrillation for more than 7 years or those with severe structural heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of atrial fibrillation in patients with obstructive sleep apnea.
How similar studies have performed: While there have been few studies on this specific relationship, the investigation of OSA's impact on AF is a novel area that has not been extensively explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan and 2 other locations
- San Luca Hospital — Milan, Italy (Recruiting)
- Cattinara Hospital — Trieste, Italy (Not_yet_recruiting)
- Danderyd Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Kristina Lundwall, MD PhD — Karolinska Institute, Danderyd Hospital
- Study coordinator: Kristina Lundwall, MD PhD
- Email: kristina.lundwall@regionstockholm.se
- Phone: +46731589999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.