CClinicalTrials.gg
CompletedNCT03366987Updated Jun 21, 2019

Nonalcoholic Fatty Liver Disease is Associated With Increased Atrial Fibrillation Risk in an Elderly Chinese Population

An observational study in Nonalcoholic Fatty Liver Disease, Atrial Fibrillation and Cross-sectional Study, sponsored by Ningbo No. 1 Hospital. Completed at 1 site in China. Open to participants aged 65 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-21.

Sponsored by Ningbo No. 1 Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
2,000
Ages
65 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Nonalcoholic Fatty Liver Disease
  • Atrial Fibrillation
  • Cross-sectional Study
03

Who can participate

Ages eligible
65 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
2,000 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Association of nonalcoholic fatty liver disease and atrial fibrillation

    The association of nonalcoholic fatty liver disease and atrial fibrillation by chi-square test.

    Time frame: the physical examination data in the year of 2014

Secondary outcomes

  1. Prevalence of AF in an elderly Chinese population stratified by normal or elevated serum liver enzyme concentration

    Prevalence of AF in an elderly Chinese population stratified by normal or elevated serum liver enzyme concentration by chi-square test.

    Time frame: the physical examination data in the year of 2014

  2. Prevalence of AF in an elderly Chinese population stratified by NAFLD status on ultrasound combined with normal or elevated serum AST/ALT/GGT concentration

    Prevalence of AF in an elderly Chinese population stratified by NAFLD status on ultrasound combined with normal or elevated serum AST/ALT/GGT concentration by chi-square test.

    Time frame: the physical examination data in the year of 2014

06

Study locations

1 site
  • Ningbo NO.1 hospital
    Ningbo, Zhejiang 315010, China
07

References and documents

Study documents

  • Study protocol · Dec 3, 2017
  • Statistical analysis plan · Dec 3, 2017

Documents are hosted by the registry — open the source record to download them.

08

Registry details

Key details

Study ID
NCT03366987
Lead sponsor
Ningbo No. 1 Hospital
Responsible party
Sponsor
First posted
Dec 8, 2017
Start date
Dec 12, 2017
Primary completion
Jan 18, 2018
Completion
Jan 30, 2018
Last update
Jun 21, 2019

Study contacts

Lei Xu, Dr.
principal investigator · Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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