Identification of Patient Phenotypes Associated With Elevated Aldosterone Levels
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern Memorial Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion criteria:
- Male or female ≥ 18 years of age
- AHF is the primary working diagnosis for ER management and treatment Have received or will receive IV diuretic therapy
- Enrolled within 12 hours of initial diuretic dose order
Exclusion criteria:
- Serum Cr ≥ 2.5mg/dL (males) or 2.0mg/dL (females), or eGFR < 20 ml/min/1.73m2
- Serum potassium ≥ 5.5 mEq/L
- Transplant recipients of any kind
- Fever > 101.0
- Severe lung disease (required home O2 or daily oral steroids)
- Acute coronary syndrome within last 30 days
- Major surgery within last 30 days
- Known hypertrophic obstructive cardiomyopathy, pericardial constriction, or hemodynamically significant valvular disease
- Life expectancy less than 12 months for any reason
- Current treatment for any malignancy of any kind
- Cardiogenic shock and/or requiring IV inotropic therapy
- Pregnant or recently pregnant within last 90 days
- Known intolerance to aldosterone antagonist
- Inability to give appropriate written consent
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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There is no prespecified primary outcome as this is an exploratory study
大体时间:2 years
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2 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
There is no secondary outcome as this is an exploratory study
大体时间:2 years
|
2 years
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To prospectively examine the baseline and dynamic phenotype of AHFS patients in relation to aldosterone levels on initial presentation.
大体时间:two years
|
Hypothesis 2.1: The "high aldosterone" phenotypic profile identified in Aim 1 will be associated with high aldosterone levels on initial presentation to the ER in our prospective replication study. Hypothesis 2.2: AHFS patients with high aldosterone levels on presentation will have increased high-sensitivity troponin release and echocardiographic markers of increased myocardial and atrial fibrosis. Hypothesis 2.3: Repeat examination at 48 hours after initial presentation will demonstrate lack of improvement in laboratory and echocardiographic biomarkers of congestion, myocyte injury, and fibrosis in AHFS patients with high aldosterone levels, suggesting a time-sensitive component to aldosterone antagonism in AHFS. |
two years
|
合作者和调查者
调查人员
- 首席研究员:Peter S Pang, MD、Northwestern University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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