Paradox: Association of Obesity and Cardiovascular Outcomes in Dilated Cardiomyopathy
Study Details
Study Description
Brief 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 dilated cardimyopathy, using a nationwide population based cohort.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 patients newly diagnosed with DCMP between January 2015 and December 2020. Patients aged <20 years, those who were already diagnosed with DCMP before 2015, and those with coronary artery disease, valvular heart disease, congenital heart disease, hypothyroidism, hyperthyroidism, and the 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients diagnosed with DCMP during study period Patients newly diagnosed with DCMP between January 2015 and December 2020 |
Other: Clinical follow up of hypertrophic cardiomyopathy
Patients diagnosed with hypertrophic cardiomyopathy during study period
Other Names:
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Outcome Measures
Primary Outcome Measures
- Composite of Outcomes [5 years]
Death + CV hospitalization + Fatal arrest event
Secondary Outcome Measures
- Death [5 years]
Mortality
- CV hospitalization [5 years]
Admission caused by Cardiovacular disease
- Fatal arrest event [5 years]
Event of cardiac arrest by ventricular tachycardia and fibrillation
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients newly diagnosed with DCMP between January 2015 and December 2020.
Exclusion Criteria:
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Patients aged <20 years
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Patients already diagnosed with DCMP before 2015
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Patients with coronary artery disease, valvular heart disease, congenital heart disease, hypothyroidism, hyperthyroidism, and the cancer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ajou University School of Medicine | Suwon | Gyeong-gido | Korea, Republic of | 16499 |
Sponsors and Collaborators
- Ajou University School of Medicine
Investigators
- Study Chair: Kwang-No LEE, Ajou University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- Rayner JJ, Peterzan MA, Clarke WT, Rodgers CT, Neubauer S, Rider OJ. Obesity modifies the energetic phenotype of dilated cardiomyopathy. Eur Heart J. 2021 Sep 20;43(9):868-77. doi: 10.1093/eurheartj/ehab663. Online ahead of print.
- AJOUIRB-EXP-2021-398-4