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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03366987
Other study ID # Ningbo2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 12, 2017
Est. completion date January 30, 2018

Study information

Verified date July 2018
Source Ningbo No. 1 Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2000
Est. completion date January 30, 2018
Est. primary completion date January 18, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Ningbo NO.1 hospital Ningbo Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Association of nonalcoholic fatty liver disease and atrial fibrillation The association of nonalcoholic fatty liver disease and atrial fibrillation by chi-square test. the physical examination data in the year of 2014
Secondary 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. the physical examination data in the year of 2014
Secondary 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. the physical examination data in the year of 2014
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