RAAS Optimization for Acute CHF Patients

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追踪信息

首次提交日期 ^ICMJE

September 19, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 3, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

January 1, 2021 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Serum Creatinine Levels[ Time Frame: Baseline, 24 hours, 48 hours, 72 hours ]

Change in serum creatinine from randomization. (AKI is defined as an increase in the serum creatinine level of more than 0.3 mg per deciliter over 48 hours)

Patient Global Assessment (well-being) over 72 hours[ Time Frame: 0 hours, 24 hours, 48 hours, 72 hours ]

Patient global assessments by modified scale (based on Borg and VAS) for 0, 24, 48, 72 hours. Scaled 1 - 10. A "1" means the patient feels the best they've ever felt and a "10" means the participant feels the worst they have ever felt. Following all time points collected, the area under the curve for global assessment over the first 72 hours will be a primary efficacy endpoint (AUC for PGA). For patient well-being (PGA) 1 Best I've ever felt 2 3 Feeling good 4 5 Feeling okay 6 7 Feeling bad 8 9 Feeling terrible 10 Worst I've ever felt

Dyspnea (shortness of breath) clinical change over 72 hours[ Time Frame: 0 hours, 24 hours, 48 hours, 72 hours ]

Patient dyspnea assessments by modified scale (based on Borg and VAS) for 0, 24, 48, 72 hours. Scaled 1 - 10. A "1" means no shortness of breath and a "10" means the patient can't breathe at all. Following all time points collected, the area under the curve for dyspnea assessment over the first 72 hours will be a primary efficacy endpoint (AUC for dyspnea). For shortness of breath (SOB) 1 No SOB at all 2 3 Slight SOB 4 5 Moderate SOB 6 7 Severe SOB 8 9 Extreme SOB 10 "I can't breathe!"

Kinetic EGFR Levels[ Time Frame: Baseline, 24 hours, 48 hours, 72 hours ]

Change in kinetic EGFR from baseline to 24, 48, and 72 hours.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Weight Change[ Time Frame: Baseline, 24 hours, 48 hours, 72 hours ]
Change in patient's weight over 3 day period.
Negative Fluid Balance[ Time Frame: Baseline, 24 hours, 48 hours, 72 hours ]
Changes in net fluid loss over 24, 48, 72 hours.
CHF Clinical Change[ Time Frame: Baseline, 72 hours ]
Change in signs and symptoms of congestion (defined as jugular venous pressure of <8 cm, with no orthopnea and with trace peripheral edema or no edema) from baseline to 24, 48, 72 hours.
Change in Renal Function[ Time Frame: Baseline, 48 hours ]
Renal biomarker (NephroCheck) levels at baseline and 48 hours. All patients receive baseline NephroCheck, and 48 hour re-assessment is limited to the first 100 patients.
Number of patients experiencing CHF Treatment Failure[ Time Frame: Over 72 hours ]
Persistent or worsening heart failure requiring additional interventions. Patients requiring other intravenous vasoactive medications for heart failure (inotropes, vasodilators, etc) for clinical reasons during the randomization period will meet the secondary endpoints of "worsening or persistent heart failure" and "treatment failure." Patients deemed to have a clinical need for additional diuretics during the study period will be permitted to receive diuretics. This will be captured as "rescue therapy" and will meet criteria for secondary endpoints of "worsening or persistent heart failure" and "treatment failure" endpoints. Conversely, patients may develop signs or symptoms of over-diuresis (such as hypotension) that will necessitate holding or discontinuing diuretics before completion of the randomization period. This will be captured as a "treatment failure" if it requires specific intervention beyond simply holding diuretics.
Hospitalization LOS[ Time Frame: Total stay during current admission ]
Length of inpatient stay
Cost Analysis[ Time Frame: Total stay during current admission ]
Cost of inpatient stay during admission.
Number of patient mortality[ Time Frame: 30 days ]
Death within 30 days of current inpatient stay (from first day of admission)
Number of patients readmitted or experiencing a ED visit[ Time Frame: 30 days ]
Readmission or ED visit at UF Health within 30 days of current inpatient stay (from first day of admission)
Number of patients readmitted over one year[ Time Frame: 1 year ]
Readmission at UF Health within 1 year of current inpatient stay (from first day of admission)

描述性信息

简略标题 ^ICMJE

RAAS Optimization for Acute CHF Patients

正式标题 ^ICMJE

Renin Angiotensin Aldosterone Optimization in Acute Decompensated Heart Failure

简要概况

Holding ACEI/ARBs during initial 72 hours of admission with acute decompensated heart failure may help preserve renal function with a lesser decline in GFR. This treatment modification will also allow the option of aggressive diuresis in volume overloaded CHF patients which should result in a lesser decline of AKI, length of stay, readmission rates, and cost associated with CHF treatment.

详细说明

The investigators hypothesize that worsening renal function can be mitigated by withholding ACEI/ARB during the initial phase of in-patient treatment with aggressive diuresis. This hypothesis will be tested by randomly allocating 360 admitted patients with ADHF on two treatment paths: 1) no ACEI/ARB administered for initial 72 hours of treatment during aggressive diuresis versus 2) full dose ACEI/ARB administered concurrently with aggressive diuresis in naïve patients/home dose, who are already on such therapy. The study team hopes to find that holding ACEI/ARBs during the initial 72 hours of admission with acute decompensated systolic heart failure will help preserve renal function, as demonstrated by a lesser decline in GFR. In addition, this treatment would allow the option of aggressive diuresis in volume overloaded CHF patients, resulting in a lesser decline of AKI, length of stay, readmission rates, and costs associated with CHF treatment. By understanding the complex interaction between holding ACEIs/ARBs and continued aggressive diuresis, the investigators intend to develop optimal dosing strategies for acute, decompensated CHF patients, further minimizing adverse events such as electrolyte issues and declining GFR/AKI.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述: The subjects will be randomized into a control group or variable group with an approximate 50/50 randomization. The control group will consist of subjects receiving ACEIs/ARBs. The variable group will consist of subjects that will not receive ACEI/ARBs during the first 72 hours of admission.
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Other: Change of treatment plan
Withholding ACEI/ARBs during initial 72 hours of admission with acute decompensated heart failure may help preserve renal function with a lesser decline in GFR. This treatment modification will also allow the option of aggressive diuresis in volume overloaded CHF patients which should result in a lesser decline of AKI, length of stay, readmission rates, and cost associated with CHF treatment.

研究工具

No Intervention: Full Dose ACEI/ARB or Home Dose Group
This group will receive the full dose of ACEI/ARBs.
Active Comparator: No ACEI/ARB Group
This group will not receive the full dose of ACEI/ARBs for the first 72 hours of hospitalization.

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

430

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

January 30, 2022

预计主要完成日期

January 1, 2021 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: Patients are eligible for enrollment if within the previous 24 hours they were treated with acute decompensated heart failure or diagnosed on the basis of the investigator's clinical diagnosis of heart failure, which needs to be supported by at least 2 the following criteria: - Elevated concentration of B-type natriuretic peptide (BNP) or N-terminal pro-BNP. (Elevated BNP" defined as >300 for sinus rhythm, >500 for patients will atrial fibrillation and elevated pro BNP defined as >1000 for sinus rhythm, >1600 for atrial fibrillation.) - Pulmonary edema on physical examination. - Radiologic pulmonary congestion or edema. - History of Chronic Heart Failure. Anticipated need for IV loop diuretics for at least 48 hours - Willingness to provide informed consent Exclusion Criteria: - Previously diagnosed end-stage renal disease; Serum Potassium >5.5 mmol/L - Cardiogenic Shock within 48 hours, ST-segment elevation myocardial infarction, ongoing ischemia. - Need for renal replacement therapy through dialysis or ultrafiltration - Myocardial infarction within 30 days of screening. - Patients with systolic blood pressure of less than 90 mm Hg. - Patients requiring Intravenous Vasodilators or inotropic agents (other than Digoxin) for heart failure - BNP less than 250 ng/ml and/or proBNP less than 1000 mg/ml - Pregnant women, prisoners, and institutionalized individuals - Severe stenotic valvular disease - Complex congenital heart disease - Need for mechanical hemodynamic support - Sepsis - Terminal illness (other than HF) with expected survival of less than one year - Previous adverse reaction to the study drugs - Use of IV iodinated radiocontrast material in last 72 hours or planned during hospitalization - Enrollment or planned enrollment in another randomized clinical trial during this hospitalization - Inability to comply with planned study procedures - Primary admission diagnosis other than acute heart failure

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：75 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

University of Florida

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Bhagwan Dass, MD University of Florida

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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