Association of Obesity and Cardiovascular Outcomes in Patients With Implantable Cardioverter-defibrillator (ICD)

Obesity Clinical Trial

— Paradox  

Official title:

Association of Obesity and Cardiovascular Outcomes in Patients With Implantable Cardioverter-defibrillator (ICD) : a Korean Nationwide Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645965
• Other study ID #: AJOUIRB-EXP-2021-398-5
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Ajou University School of Medicine
• Contact: Kwang-No LEE
• Phone: +82-9286-1123
• Email: knlee81[@]ajou.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, the investigators evaluated the association between various measures of adiposity [BMI and waist circumference (WC)] and clinical outcomes in Asian patients who underwent Implantable Cardioverter-defibrillator (ICD) insertion, using a nationwide population based cohort.

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 patients who underwent implantable cardioverter-defibrillator (ICD) insertion between January 2015 and December 2020. Patients aged <20 years, those who were already taken ICD insertion before 2015, and those with cancer were excluded from the analysis. The follow-up period was defined as the time from the index date (date of device procedure) 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.

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]. The investigators defined the proportion of medical use by calculating formula with the recuperation cost and the number of the visit to hospitals.

During the follow-up period, the investigators assessed 3 clinical outcomes, including all-cause death, cardiovascular hospitalization and the recurrence rate. Clinical outcomes were mainly defined by the the International Classification of Diseases, 10th revision (ICD-10). Patients were censored at the clinical outcomes or the end of the study period (December 31, 2020), whichever came first.

All categorical variables are presented as frequencies and percentages. Normally distributed data were presented as mean ± standard deviation, whereas nonparametric data are presented as median and interquartile range by BMI.

Cox proportional hazard regression analyses were performed to identify the association of BMI with the primary and secondary outcomes, calculating hazard ratio (HR) and 95% confidence interval (CI) and adjusting for the following potential confounders: sex, age, systolic blood pressure, fasting glucose level, total cholesterol level, alcohol consumption, smoking status, physical activity, household income, use of antihypertensive agents, use of statins, use of antiplatelet agents, previous history of MI, previous history of stroke, and index year. All analyses were conducted using R-statistics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who underwent implantable cardioverter-defibrillator (ICD) insertion between January 2015 and December 2020

Exclusion Criteria:

• Patients aged <20 years

• Patients already taken ICD insertion before 2015

• Patients with cancer

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiovascular Morbidity
• Implantable Defibrillator User
• Obesity

Intervention

Device:
• ICD insertion
Patients who underwent implantable cardioverter-defibrillator (ICD) insertion between January 2015 and December 2020

Locations

Country	Name	City	State
Korea, Republic of	Ajou University School of Medicine	Suwon	Gyeong-gido

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Echouffo-Tcheugui JB, Masoudi FA, Bao H, Curtis JP, Heidenreich PA, Fonarow GC. Body mass index and outcomes of cardiac resynchronization with implantable cardioverter-defibrillator therapy in older patients with heart failure. Eur J Heart Fail. 2019 Sep;21(9):1093-1102. doi: 10.1002/ejhf.1552. Epub 2019 Jul 29. — View Citation

Kim MS, Kim WJ, Khera AV, Kim JY, Yon DK, Lee SW, Shin JI, Won HH. Association between adiposity and cardiovascular outcomes: an umbrella review and meta-analysis of observational and Mendelian randomization studies. Eur Heart J. 2021 Sep 7;42(34):3388-3403. doi: 10.1093/eurheartj/ehab454. — View Citation

Samanta R, Narayan A, Pouliopoulos J, Kovoor P, Thiagalingam A. Influence of Body Mass Index on Recurrence of Ventricular Arrhythmia, Mortality in Defibrillator Recipients With Ischaemic Cardiomyopathy. Heart Lung Circ. 2020 Feb;29(2):254-261. doi: 10.1016/j.hlc.2018.12.018. Epub 2019 Jan 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Outcomes	Death + CV hospitalization + Fatal arrest event + Infective endocarditis	5 years
Secondary	Death	Mortality	5 years
Secondary	CV hospitalization	Admission caused by Cardiovacular disease	5 years
Secondary	Fatal arrest event	Event of cardiac arrest by ventricular tachycardia and fibrillation	5 years
Secondary	Infective endocarditis	Diagnosed with infective endocarditis	5 years