PRevalence of Obstructive Sleep apnoEa and Reduction of Promoters in AF

Atrial Fibrillation Clinical Trial

— PROSERPin-AF  

Official title:

Prevalenza Delle Apnee Notturne e Riduzione Dei Fattori Promotori Nella Fibrillazione Atriale

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05784077
• Other study ID #: 09C020
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 343
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Osa Syndrome

Intervention

Diagnostic Test:
• Polysomnography
Study of the sleep pattern

Behavioral:
• Lifestyle counselling
Weight loss counselling

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in prevalence of obstructive sleep apnoea in patients with atrial fibrillation	Change in prevalence of obstructive sleep apnoea from baseline to 3 years	Baseline and at 3, 6, 12, 24 and 36 months
Primary	Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation	Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation	Baseline
Secondary	Change in body weight	Change in body weight from baseline to 3 years	Baseline and at 3, 6, 12, 24 and 36 months
Secondary	Change in incidence of atrial fibrillation recurrencies	Change in incidence of atrial fibrillation recurrencies from baseline to 3 years	Baseline and at 3, 6, 12, 24 and 36 months
Secondary	Change in quality of life	Change in quality of life from baseline to 3 years	Baseline and at 3, 6, 12, 24 and 36 months