Nonalcoholic Fatty Liver DiseaseNCT03366987
Nonalcoholic Fatty Liver Disease is Associated With Increased Atrial Fibrillation Risk in an Elderly Chinese Population
An observational study of Nonalcoholic Fatty Liver Disease and Atrial Fibrillation, run by Ningbo No. 1 Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease, Atrial Fibrillation, Cross-sectional Study
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2017to 30 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The elderly adults (≥65 years old) who had undergone an annual physical examination at Zhenhai Lianhua Hospital, Ningbo, China in 2014
Who may be able to join
- those who undergone an annual physical examination at Zhenhai Lianhua Hospital, Ningbo, China in 2014
- elderly adults (≥65 years old)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nonalcoholic Fatty Liver Disease is Associated With Increased Atrial Fibrillation Risk in an Elderly Chinese Population: a Cross-sectional Study
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.
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of nonalcoholic fatty liver disease and atrial fibrillation
The association of nonalcoholic fatty liver disease and atrial fibrillation by chi-square test.
Measured: the physical examination data in the year of 2014
Secondary outcomes (2)
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.
Measured: the physical examination data in the year of 2014
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.
Measured: the physical examination data in the year of 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start12 Dec 2017
- Primary completion18 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Xu, Dr., Principal investigator, Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366987
- Sponsor's protocol ID
- Ningbo2
- Status last verified
- Jul 2018
- First submitted
- 26 Oct 2017
- Last updated
- 21 Jun 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonalcoholic Fatty Liver Disease is Associated With Increased Atrial Fibrillation Risk in an Elderly Chinese Population: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03366987
- Acronym / sponsor ID
- Ningbo2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The elderly adults (≥65 years old) who had undergone an annual physical examination at Zhenhai Lianhua Hospital, Ningbo, China in 2014
Key inclusion criteria (2 listed)
- those who undergone an annual physical examination at Zhenhai Lianhua Hospital, Ningbo, China in 2014
- elderly adults (≥65 years old)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association of nonalcoholic fatty liver disease and atrial fibrillation
Time frame: the physical examination data in the year of 2014
The association of nonalcoholic fatty liver disease and atrial fibrillation by chi-square test.
2 secondary outcomes
Prevalence of AF in an elderly Chinese population stratified by normal or elevated serum liver enzyme concentration
Time frame: the physical examination data in the year of 2014
Prevalence of AF in an elderly Chinese population stratified by NAFLD status on ultrasound combined with normal or elevated serum AST/ALT/GGT concentration
Time frame: the physical examination data in the year of 2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Xu, Dr. principal investigator
Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonalcoholic Fatty Liver Disease and Atrial Fibrillation, run by Ningbo No. 1 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of nonalcoholic fatty liver disease and atrial fibrillation (time frame: the physical examination data in the year of 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.