Association of Obesity and Cardiovascular Outcomes in Hypertrophic Cardiomyopathy

Obesity Clinical Trial

— Paradox  

Official title:

Association of Obesity and Cardiovascular Outcomes in Patients With Hypertrophic Cardiomyopathy : a Korean Nationwide Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645939
• Other study ID #: AJOUIRB-EXP-2021-398-3
• 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 [Patient Registry]

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 with hypertrophic cardiomyopathy, 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 newly diagnosed with HCMP between January 2015 and December 2020. Patients aged <20 years, those who were already diagnosed with HCMP 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 diagnosis) 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: 30000
• 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 newly diagnosed with HCMP between January 2015 and December 2020

Exclusion Criteria:

• Patients aged <20 years

• Patients diagnosed with HCMP before 2015

• Patients with cancer

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Cardiovascular Morbidity
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Obesity

Intervention

Other:
• Diasgnosis of hypertrophic cardiomyopathy
Patients diagnosed with hypertrophic cardiomyopathy during study period

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)

Castleberry CD, Jefferies JL, Shi L, Wilkinson JD, Towbin JA, Harrison RW, Rossano JW, Pahl E, Lee TM, Addonizio LJ, Everitt MD, Godown J, Mahgerefteh J, Rusconi P, Canter CE, Colan SD, Kantor PF, Razoky H, Lipshultz SE, Miller TL. No Obesity Paradox in Pediatric Patients With Dilated Cardiomyopathy. JACC Heart Fail. 2018 Mar;6(3):222-230. doi: 10.1016/j.jchf.2017.11.015. Epub 2018 Feb 7. — 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

Moon I, Lee SY, Kim HK, Han KD, Kwak S, Kim M, Lee HJ, Hwang IC, Lee H, Park JB, Yoon YE, Kim YJ, Cho GY. Trends of the prevalence and incidence of hypertrophic cardiomyopathy in Korea: A nationwide population-based cohort study. PLoS One. 2020 Jan 13;15(1):e0227012. doi: 10.1371/journal.pone.0227012. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Outcomes	Death + CV hospitalization + Fatal arrest event	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