Intensive glycemic control for congestive heart failure exacerbation

描述(由申请人提供)： 充血性心力衰竭与严重的代谢和神经激素紊乱有关。这可能会导致长期住院和病情恶化的再住院率。在CMF患者中，糖尿病和血糖控制是死亡率的独立危险因素。因此，CHF恶化的住院患者可能特别适合改善血糖控制。然而，还没有研究前瞻性地研究入院治疗的CHF患者是否会从改善血糖控制中受益。这项研究的主要目的是确定早期静脉(IV)胰岛素治疗是否改善住院时间和自主神经张力(通过心率变异性[HRV]进行评估，心率变异性[HRV]是CHF患者死亡率的独立预测因素)。在次要目标中，这项研究将评估早期静脉注射胰岛素是否影响自主神经张力的其他指标(血压变异性[BPV]和儿茶酚胺水平)、生理参数，如血浆容量、心脏指数和BNP，生活质量，以及对脂联素异构体的影响，脂联素是对胰岛素敏感性至关重要的重要脂肪因子。在探索性目标中，这项研究将检查血糖变异性的影响，以及早期静脉注射胰岛素是否会带来任何成本效益。该方案将在俄亥俄州立大学罗斯心脏医院服务的240名因收缩功能障碍(射血分数&35%)导致失代偿性心力衰竭的患者中进行。患者将被随机分配到两组中的一组：(1)早期静脉注射胰岛素治疗，目标是血糖101-150 mg/dL，或(2)标准化的生理性皮下胰岛素方案。静脉注射胰岛素将持续至少72小时，然后过渡到皮下注射胰岛素。出院后30天，将联系患者以确定处理方式并进行生活质量评分。主要结果包括住院时间和心率变异，而次要结果包括BPV、儿茶酚胺水平、心脏指数、血浆容量、BNP、生活质量评分和脂联素。相关性：心力衰竭是糖尿病死亡的主要原因，并导致长时间住院和频繁的再住院。初步研究表明，糖尿病控制越差的患者死亡率越高。本研究将探讨早期更好的糖尿病控制是否会改善医院的结果。

DESCRIPTION (provided by applicant): CHF is associated with profound metabolic and neurohormonal disturbances. These may contribute to prolonged hospitalizations and readmission rates for exacerbations. In patients with CMF, diabetes and glycemic control are independent risk factors for mortality. Therefore, hospitalized patients with CHF exacerbation may be particularly suited for improved glycemic control. However, no studies have prospectively examined whether patients hospitalized with CHF would benefit from improved glucose control. The primary aims of this study are to determine whether early intravenous (IV) insulin therapy improves hospital length of stay and autonomic tone (assessed with heart rate variability [HRV], an independent predictor of mortality in patients with CHF. In secondary aims, the study will asses whether early IV insulin impacts other measures of autonomic tone (blood pressure variability [BPV] and catecholamine levels), physiologic parameters, such as plasma volume, cardiac index, and BNP, quality of life, and finally the effects on adiponectin isomers, which are important adipokines important for insulin sensitivity. In exploratory aims, the study will examine the effect of glycemic variability and whether any cost benefit is projected with early IV insulin. This protocol will be conducted among 240 patients admitted to the OSU Ross Heart Hospital service with decompensated heart failure due to systolic dysfunction (ejection fraction<35%). Patients will be randomly assigned to one of 2 groups: (1) early IV insulin therapy targeting a blood glucose of 101-150 mg/dL, or (2) a standardized physiologic subcutaneous insulin regimen. Intravenous insulin will be continued for a minimum of 72 hours, followed by transition to subcutaneous insulin. 30 days following discharge, patients will be contacted to determine disposition and to administer quality of life scores. Primary outcomes include hospital length of stay and HRV whereas secondary outcomes include BPV, catecholamine levels, cardiac index, plasma volume, BNP, quality of life scores, and adiponectin. RELEVANCE: Heart failure is a leading cause of mortality from diabetes and leads to prolonged hospital stays with frequent readmissions. Preliminary studies suggest that patients with worse diabetes control have higher mortality. The present study will address whether better early diabetes control improves hospital outcomes.