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临床试验/NCT04450576
NCT04450576Unknown不适用

HbA1c as an Early Serologic Marker for the Hemodynamic Progression of Stage A Heart

Parkview Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年12月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Left Atrial volume

研究概览

简要总结

In a retrospective community based cohort study from Pueblo County Colorado which has a higher population proportion of metabolic syndrome and diabetes mellitus, we hope to clarify and quantify an association of the AGE HBa1c elevation with the early subclinical hemodynamic changes of diabetic cardiomyopathy as measured by LAV, LVM, E/A ratio, E/e' ratio and BNP in patients with stage A heart failure.

详细描述

The classic association of glycemic control, as represented by HBa1c, with progression or improvement of microvascular and macrovascular clinical complications has been well documented. Additionally, while the association of HBa1c elevation with a syndrome described as diabetic cardiomyopathy has also been well documented, the use of the advanced glycation end product axis (AGE/sRAGE/esRAGE which includes HBa1c) as markers for the early subclinical hemodynamic changes of diabetic cardiomyopathy has been suggested but less well characterized or utilized. Stage A heart failure is defined as persons with normal cardiac structure and function who have predisposing subclinical risks for cardiovascular disease. Estimates suggest that Stage A heart failure may comprise up to 56% of any community's patient population and are patients most commonly seen in non-specialty primary care clinics. In light of newer cardiometabolic agents which show promise in cardiovascular disease primary prevention, these patients may be an important target for preventative cardiometabolic care. In a retrospective community based cohort study from Pueblo County Colorado which has a higher population proportion of metabolic syndrome and diabetes mellitus, we hope to clarify and quantify an association of the AGE HBa1c elevation with the early subclinical hemodynamic changes of diabetic cardiomyopathy as measured by LAV, LVM, E/A ratio, E/e' ratio and BNP in patients with stage A heart failure.

Methods: Retrospective cohort analysis by chart review of patients presenting to Parkview Medical Center's inpatient service and outpatient clinics who obtained a full resting echo characterized by normal cardiac structure and function in conjunction with HBa1c and BNP levels within a 3 month time window. Using multiple regression analysis of the dependent variables LAV, LVM, E/A ratio, E/e' ratio and BNP, powered to detect a 5% change in LAV in conjunction with rising HBa1c levels characterized as normal (<5.7), metabolic syndrome (5.7-6.4) or diabetic (>6.4) after controlling for the presence of hypertension and coronary artery disease.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

接受健康志愿者

入选标准

  • Stage A heart failure on basis of metabolic criteria

排除标准

  • LV dysfunction, valvular heart disease, hypertension and CAD

结局指标

主要结局

Left Atrial volume

时间窗: 3 months

Echocardiogram

次要结局

  • BNP(3 months)
  • E/e'(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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