Heart failure, chronic kidney disease, and renin-angiotensin system inhibition

心力衰竭、慢性肾脏疾病和肾素-血管紧张素系统抑制

基本信息

批准号：
7625161
负责人：
ALI AHMED
金额：
$ 31.79万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-08-15 至 2012-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7625161
关键词：
Abbreviations Acute Admission activity African American Age Aging Alabama Aldosterone American American Heart Association Angiotensin II Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Angiotensin-Converting Enzyme Inhibitors Belief Cardiology Caring Cessation of life Chronic Chronic Kidney Failure Clinical Data Confidence Intervals Contracts Creatinine Data Data Files Data Set Diastolic heart failure Diet Modification Digitalis preparation Disease Drug usage EFRAC Educational process of instructing Elderly Enalapril End stage renal failure Enrollment Foundations Glomerular Filtration Rate Goals Guidelines Heart Heart failure Hospitalization Hospitals Inpatients Investigation Kidney Kidney Diseases Lead Left Left Ventricular Dysfunction Left Ventricular Ejection Fraction Life Long-Term Effects Management Information Systems Medicare National Heart, Lung, and Blood Institute Neurohormones New York Observational Study Odds Ratio Outcome Pathogenesis Patient Care Patient Representative Patients Perception Pharmaceutical Preparations Policies Population Prevalence Principal Investigator Property Provider Randomized Randomized Controlled Trials Renin-Angiotensin System Research Research Personnel Serum Severities Source Specialized Center Systolic heart failure Techniques Time United States Centers for Medicare and Medicaid Services United States National Institutes of Health Universities Ventricular Dysfunction Vital Status Woman base clinical practice cohort college cost design evidence base evidence based guidelines hazard health care quality high risk improved mortality outcome forecast programs quality assurance quality improvement organization receptor treatment effect young adult

项目摘要

DESCRIPTION (provided by applicant): Most heart failure (HF) patients suffer from chronic kidney disease (CKD). HF patients with CKD have one of the poorest prognoses, yet they are also least likely to receive life-saving medications such as angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ACEI/ARB). There have been no randomized controlled trials (RCT) of ACEI/ARB in HF-CKD patients to guide clinical practice, and none are likely to be conducted soon. Moreover, clinicians often perceive ACE/AB-associated rise in serum creatinine as an indication of renal damage. This belief and practice engrained in traditional teaching is unlikely to change without strong evidence of survival benefit of ACEI/ARB in HF-CKD patients. Our specific hypothesis is that ACEI/ARB would reduce mortality and hospitalization in HF patients with CKD. We base our hypothesis on the fact that activation of the renin-angiotensin system (RAS) forms the basis of the pathogenesis and progression of both HF and CKD, suppression of which forms the basis of cardio- and reno-protective properties of ACEI/ARB. Therefore, we postulate that patients with both HF and CKD will benefit from these drugs. Alabama HF Project (AHFP) is a large (8555 patients from 106 hospitals), recent (1998-2001), and rich dataset with -200 well-defined variables including serum creatinine, ejection fraction, and medications. The AHFP cohort closely resembles real-life HF patients in terms of age (mean 77 years) and diversity (>50% women, > 20% non-whites), allowing the assessment of patients often excluded from RCT. In addition, Studies of Left Ventricular Dysfunction (SOLVD) (N=2569; 83 hospitals; mean age 61 years, 20% women, 20% nonwhite) data will be use to study the effect of ACEI of ambulatory systolic HF patients with CKD. The specific aims of this study are to determine the effects of ACEI/ARB on mortality and hospitalization in systolic and diastolic HF patients with CKD, and the effect of ARB (versus ACEI) on mortality and hospitalization in HF-CKD patients using propensity score technique. Our long-term goal is to produce strong evidence, based on a rigorously designed and conducted non- randomized study, which will challenge existing clinical practice of nonuse/underuse of ACEI/ARB in HF- CKD patients, and improve quality and outcomes of HF care.

描述（由申请人提供）：大多数心力衰竭（HF）患者患有慢性肾病（CKD）。合并 CKD 的心力衰竭患者是预后最差的患者之一，但他们也最不可能接受血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂 (ACEI/ARB) 等救生药物。目前还没有针对 HF-CKD 患者的 ACEI/ARB 随机对照试验 (RCT) 来指导临床实践，而且短期内也不会进行此类试验。此外，临床医生经常将 ACE/AB 相关的血清肌酐升高视为肾损伤的征兆。如果没有强有力的证据证明 ACEI/ARB 对 HF-CKD 患者的生存有益，这种传统教学中根深蒂固的信念和实践不太可能改变。我们的具体假设是 ACEI/ARB 会降低 CKD 心衰患者的死亡率和住院率。我们的假设基于以下事实：肾素-血管紧张素系统 (RAS) 的激活构成了 HF 和 CKD 发病机制和进展的基础，对其抑制构成了 ACEI/ARB 的心脏和肾保护特性的基础。因此，我们假设同时患有 HF 和 CKD 的患者将从这些药物中受益。阿拉巴马心力衰竭项目 (AHFP) 是一个大型（来自 106 家医院的 8555 名患者）、最近（1998-2001 年）且丰富的数据集，包含 -200 个明确定义的变量，包括血清肌酐、射血分数和药物。 AHFP 队列在年龄（平均 77 岁）和多样性（> 50% 女性，> 20% 非白人）方面与现实生活中的心力衰竭患者非常相似，因此可以对经常被排除在 RCT 之外的患者进行评估。此外，左心室功能障碍研究 (SOLVD)（N=2569；83 家医院；平均年龄 61 岁，20% 女性，20% 非白人）数据将用于研究 ACEI 对 CKD 动态收缩性心力衰竭患者的影响。本研究的具体目的是利用倾向评分技术确定 ACEI/ARB 对 CKD 收缩期和舒张期 HF 患者死亡率和住院率的影响，以及 ARB（与 ACEI）对 HF-CKD 患者死亡率和住院率的影响。我们的长期目标是在严格设计和进行的非随机研究的基础上提供强有力的证据，这将挑战 HF-CKD 患者不使用/未充分使用 ACEI/ARB 的现有临床实践，并提高 HF 的质量和结果关心。