Association of Obesity and Cardiovascular Outcomes in Hypertrophic Cardiomyopathy
NCT ID: NCT05645939
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30000 participants
OBSERVATIONAL
2022-07-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Patients diagnosed with HCMP during study period
Patients newly diagnosed with HCMP between January 2015 and December 2020
Diasgnosis of hypertrophic cardiomyopathy
Patients diagnosed with hypertrophic cardiomyopathy during study period
Interventions
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Diasgnosis of hypertrophic cardiomyopathy
Patients diagnosed with hypertrophic cardiomyopathy during study period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients diagnosed with HCMP before 2015
* Patients with cancer
20 Years
ALL
Yes
Sponsors
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Ajou University School of Medicine
OTHER
Responsible Party
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Kwang-No Lee
Professor
Principal Investigators
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Kwang-No LEE
Role: STUDY_CHAIR
Ajou University School of Medicine
Locations
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Ajou University School of Medicine
Suwon, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Kwang-No LEE
Role: primary
References
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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.
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.
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.
Other Identifiers
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AJOUIRB-EXP-2021-398-3
Identifier Type: -
Identifier Source: org_study_id
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