Clinical trial NCT03366987: Nonalcoholic Fatty Liver Disease is Associated With Increased Atrial Fibrillation Risk in an Elderly Chinese Population
Official title: Nonalcoholic Fatty Liver Disease is Associated With Increased Atrial Fibrillation Risk in an Elderly Chinese Population: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonalcoholic Fatty Liver Disease
Atrial Fibrillation
Cross-sectional Study
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The elderly adults (≥65 years old) who had undergone an annual physical examination at Zhenhai Lianhua Hospital, Ningbo, China in 2014

Brief summary: Atrial fibrillation and nonalcoholic fatty liver disease are two pathological conditions that are highly prevalent worldwide and share multiple CVD risk factors. There is rare research performed among elderly adults. The investigators are conducting a cross-sectional analysis of elderly adults (≥65 years) to investigate the association between atrial fibrillation and nonalcoholic fatty liver disease in an elderly Chinese population.

Detailed description: Because of the aging population and improvements in cardiovascular treatments, its prevalence is expected to increase substantially over the next few decades. AF has been reported to be associated with high rates of hospitalization and death. Along with older age, there are many independent risk factors for AF like obesity, hypertension, diabetes, ischemic heart disease, heart failure and valvular heart disease.

Non-alcoholic fatty liver disease is one of the most prevalent liver diseases in the world whose prevalence ranges from 6% to 35%, with a median of 20% in the general population. In recent years, an increasing body of evidence have indicated that NAFLD is linked to cardiovascular disease, myocardial abnormalities, left ventricular diastolic dysfunction, heart failure, aortic valve sclerosis and so on.

NAFLD has also been observed to be significantly associated with AF in patients with type 2 diabetes. Furthermore, a cohort study showed that NAFLD was associated with an increased risk of prevalent AF in a middle-aged population. However, whether the association between NAFLD and AF also holds true in the elderly population remains uncertain. Therefore, the investigators conducted this cross-sectional study to explore the association between NAFLD and AF in an elderly Chinese population.

Eligibility criteria: Inclusion Criteria:

* those who undergone an annual physical examination at Zhenhai Lianhua Hospital, Ningbo, China in 2014
* elderly adults (≥65 years old)

Exclusion Criteria:

* unknown alcohol intake or excessive alcohol intake
* unknown BMI or BMI≤18.0kg/m2
* incomplete basic physical data
* missing liver ultrasonic diagnosis
* unknown causes of chronic liver disease

Primary outcomes:
measure: Association of nonalcoholic fatty liver disease and atrial fibrillation
timeFrame: the physical examination data in the year of 2014
Secondary outcomes:
measure: Prevalence of AF in an elderly Chinese population stratified by normal or elevated serum liver enzyme concentration
timeFrame: the physical examination data in the year of 2014
measure: Prevalence of AF in an elderly Chinese population stratified by NAFLD status on ultrasound combined with normal or elevated serum AST/ALT/GGT concentration
timeFrame: the physical examination data in the year of 2014
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo NO.1 hospital
state: Zhejiang
Study officials:
affiliation: Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China
name: Lei Xu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: