Association of Obesity and Cardiovascular Outcomes in Atrial Fibrillation (Paradox)

July 26, 2023 updated by: Kwang-No Lee, Ajou University School of Medicine

Association of Obesity and Cardiovascular Outcomes in Patients With Atrial Fibrillation : a Korean Nationwide Cohort Study

In this study, the investigators evaluated the association between various measures of adiposity [BMI and waist circumference (WC)] and clinical outcomes in Asian patients with AF who were prescribed OAC, using a nationwide population based cohort.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This retrospective nationwide cohort study used administrative claims data from the Korean National Health Insurance Service (NHIS) and the combined health check-up database of the National Health Insurance Corporation between 2013 and 2020.

The investigators included oral anticoagulant (OAC) new users diagnosed with atrial fibrillation (AF) between January 2015 and December 2020. Patients aged <20 years, those who were regarded as valvular AF patients (patients with mitral stenosis or prosthetic heart valve), those with possible alternative indications for OAC (pulmonary embolism, deep vein thrombosis, or recent joint replacement surgery), and those with cancer were excluded from the analysis.

The follow-up period was defined as the time from the index date (date of OAC prescription) to each outcome event, date of death, or end of the study period (December 31, 2020), whichever came first.

Patients' demographic data, comorbidities, concomitant medications, and income level were collected from the Korean NHIS database. The recent health check-up data from the index date was also ascertained, including height, weight, waist circumference, blood pressure, health surveys, and laboratory exam. Health survey included family history, smoking history, alcohol history, and the level of individual physical activity. The investigators defined the proportion of medical use by calculating formula with the recuperation cost and the number of the visit to hospitals.

According to BMI following the World Health Organization recommendation for Asian population, study patients were categorized into 5 groups: underweight, <18.5 kg/m2; normal range, 18.5 to <23 kg/m2; overweight, 23 to <25 kg/m2; obese I, 25 to <30 kg/m2; and obese II, ≥30 kg/m2[4].

During the follow-up period, the investigators assessed 3 clinical outcomes, including thromboembolism, major bleeding, all-cause death, and a composite clinical outcome of thromboembolism+major bleeding+all-cause death. Major bleeding included the brain hemorrhage and gastrointestinal bleeding. Clinical outcomes were mainly defined by the the International Classification of Diseases, 10th revision (ICD-10). Patients were censored at the clinical outcomes, the discontinuation of index OAC treatment, or the end of the study period (December 31, 2020), whichever came first.

Continuous variables are presented as mean±SD or median (interquartile ranges). Categorical variables are presented as numbers and percentages. Baseline characteristics were compared across 5 BMI categories with a linear trend test using a generalized linear model for continuous variables and the Cochran-Armitage trend test for categorical variables. The incidence rates of clinical outcomes were calculated based on the number of events during the follow-up period divided by 100 person-years at risk.

For the primary analyses to evaluate the association between BMI and clinical outcomes in AF patients treated with OAC, the investigators conducted 2 types of analyses: (1) BMI as a continuous variable and (2) BMI as a categorical variable by predefined BMI ranges. First, the association between BMI as a continuous variable (per 5 kg/m2 increase) and clinical outcomes was evaluated using a Cox proportional hazard model to derive unadjusted and adjusted hazard ratios (HRs). Adjusted cubic spline curves were used to visualize the relationship between BMI and the risk of clinical outcomes. Second, the association between different BMI categories and clinical outcomes was explored using adjusted Cox proportional hazard models. Patients with a normal range of BMI defined as 23 to <25 kg/m2 were used as the reference group. Covariates in the multivariable analysis included age, sex, CHA2DS2-VASc score, comorbidities, renal function, use of antiplatelet agents, and OAC treatment (warfarin or non-vitamin K antagonist OAC [NOAC]).

All analyses were 2 tailed, and P<0.05 was considered significant. Statistical analyses were conducted with R-statistics.

Study Type

Observational

Enrollment (Actual)

56272

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeong-gido
      • Suwon, Gyeong-gido, Korea, Republic of, 16499
        • Ajou University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This retrospective nationwide cohort study used administrative claims data from the Korean National Health Insurance Service (NHIS) and the combined health check-up database of the National Health Insurance Corporation between 2013 and 2020.

We included oral anticoagulant (OAC) new users diagnosed with atrial fibrillation (AF) between January 2015 and December 2020. Patients aged <20 years, those who were regarded as valvular AF patients (patients with mitral stenosis or prosthetic heart valve), those with possible alternative indications for OAC (pulmonary embolism, deep vein thrombosis, or recent joint replacement surgery), and those with cancer were excluded from the analysis.

Description

Inclusion Criteria:

  • Oral anticoagulant (OAC) new users diagnosed with atrial fibrillation (AF) between January 2015 and December 2020

Exclusion Criteria:

  • Patients aged <20 years
  • Valvular AF patients
  • Possible alternative indications for OAC (pulmonary embolism, deep vein thrombosis, or recent joint replacement surgery)
  • Cancer patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atrial fibrillation with oral anticoagulant
patients who were newly receiving an oral anticoagulant for atrial fibrillation during study period
Drug: Oral anticoagulant
Oral anticoagulant that was continued at least 25days, inculding warfarin and new oral anticoagulant (NOAC)
Other Names:
  • Oral anticoagulant medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of Outcomes
Time Frame: 5 years
Thromboembolism+Bleeding+Death
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 5 years
Mortality
5 years
Thromboembolism
Time Frame: 5 years
Stroke, Myocardial infarction
5 years
Bleeding
Time Frame: 5 years
Intracranial hemorrhage, Hospitalization for GI bleeding
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Investigators

  • Principal Investigator: Kwang-No LEE, Ajou University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 2, 2022

First Submitted That Met QC Criteria

December 2, 2022

First Posted (Actual)

December 12, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJOUIRB-EXP-2021-398

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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