PROSERPin-AF: PRevalence of Obstructive Sleep apnoEa and Reduction of Promoters in AF

• Sponsor: Istituto Auxologico Italiano (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05784077
• Collaborator: (none)
• Enrollment: 343
• Location: 1
• Anticipated Duration (Months): 61
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

This study aims to identify how many patients who have atrial fibrillation, also have sleep apnoea. This is important because sleep apnoea can be a trigger to atrial fibrillation and it can be corrected with a simple intervention. Therefore it is important to understand its prevalence (how many patients with atrial fibrillation are affected by it). Also, obesity and sleep disorders are often associated, therefore the evolution of atrial fibrillation is studied in patients who also have obesity and have lost weight compared with patients who did not loose any weight or are not obese. As medications or therapy are not changed, this is an observational study.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Osa Syndrome	Diagnostic Test: Polysomnography; Behavioral: Lifestyle counselling

Study Design

• Study Type: Observational
• Anticipated Enrollment: 343 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prevalenza Delle Apnee Notturne e Riduzione Dei Fattori Promotori Nella Fibrillazione Atriale
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jan 31, 2025

Outcome Measures

Primary Outcome Measures

1. Change in prevalence of obstructive sleep apnoea in patients with atrial fibrillation [Baseline and at 3, 6, 12, 24 and 36 months]

   Change in prevalence of obstructive sleep apnoea from baseline to 3 years

2. Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation [Baseline]

   Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation

Secondary Outcome Measures

1. Change in body weight [Baseline and at 3, 6, 12, 24 and 36 months]

   Change in body weight from baseline to 3 years

2. Change in incidence of atrial fibrillation recurrencies [Baseline and at 3, 6, 12, 24 and 36 months]

   Change in incidence of atrial fibrillation recurrencies from baseline to 3 years

3. Change in quality of life [Baseline and at 3, 6, 12, 24 and 36 months]

   Change in quality of life from baseline to 3 years

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All

Inclusion Criteria primary outcome:

• 1 episode of atrial fibrillation in the previous year

Inclusion Criteria secondary outcome:

• BMI > o = 27Kg/m2

• AHI >30 o con 15<AHI<30 associated with other symptoms (sleeplessness, uncontrolled hypertension and cerebral events)

Exclusion Criteria:

• Ejection Fraction <50%

• HFpEF not related to atrial fibrillation.

• coronary artery disease

• valvular cardiomyopathy

• patient already in treatment for sleep apnoea

• hyperthyroidism

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Auxologico Italiano	Milan		Italy	20145

Sponsors and Collaborators

• Istituto Auxologico Italiano

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istituto Auxologico Italiano
• ClinicalTrials.gov Identifier: NCT05784077
• Other Study ID Numbers: 09C020
• First Posted: Mar 24, 2023
• Last Update Posted: Mar 24, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Mar 24, 2023