Adaptive Servo-Ventilation In Acute Heart Failure Patients Protecting the Heart
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in Renal Biomarkers
研究概览
简要总结
The primary hypothesis of this study is: the use of minute ventilation-adaptive servo-ventilation (MV-ASV) during hospitalization will mitigate deterioration in renal function and prevent kidney injury in patients admitted with acute heart failure (AHF) compared to those receiving usual care. We will validate and extend our pilot study by taking a deeper dive into the effects of ASV on diuretic dose, urine output and new and exciting biomarkers of renal function and kidney injury. If our hypothesis proves correct, it strongly suggests that ASV lessens injury to the kidney and could lead to a new paradigm for the treatment of AHF. When use of high dose of diuretics are anticipated or in whom chronic kidney disease (CKD) or acute kidney injury (AKI) is present on arrival to the Emergency Department, use of MV-ASV might decrease the amount of diuretics needed, allow for continued use of ACE inhibitors, and ultimately mitigate rises in creatinine and decreases in effective glomerular filtration. Since kidney injury is a major factor in those patients with early 30-day readmission following discharge, this therapy could become quite popular.
详细描述
OBJECTIVE(S): The main goal of this study is to evaluate the utility of a Minute Ventilation Adaptive Servo-ventilation (MV-ASV) device in mitigating deterioration in renal function and prevent kidney injury in patients admitted with acute heart failure compared to those receiving usual care. We will be assessing the effects of MV-ASV on diuretic dose, urine output and new and exciting biomarkers of renal function and kidney injury. If our hypothesis proves correct, it strongly suggests that ASV lessens hypoxia to the kidney and could lead to a new paradigm for the treatment of AHF. When use of high dose of diuretics are anticipated or in whom CKD or AKI is present on arrival to the Emergency Department, use of MV-ASV might decrease the amount of diuretics needed, allow for continued use of ACE inhibitors, and ultimately mitigate rises in creatinine and decreases in effective glomerular filtration. Since kidney injury is a major factor in those patients with early 30-day readmission following discharge, this therapy could become quite popular.
RESEARCH DESIGN: This is an interventional, principal investigator-initiated project with patient enrollment, cohort development and data analysis. We will recruit 66 patients with acute heart failure and evidence of volume overload and elevated BNP, since we anticipate a 10% dropout. Half will be pre-selected to have CKD with eGFR < 60 ml/min/1.73 m2. Randomization will be attempted within first six hours of hospital presentation. The participants will be randomized one of the following two groups: 1) those receiving only standard therapy or 2) those receiving standard therapy and adaptive servo-ventilation (ASV) therapy.
METHODOLOGY:
Methods:
- Consenting of patient: every attempt will be made to consent within six hours of evaluation, as we feel there is a good window for ASV here. Maximum time to consent is 24 hours.
- Sleep and breathing assessment: Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale, Pulmonary Sleep Lab Questionnaire, Sleep Diary, Likert Scale
- Blood Sample Collections:
- Two 10cc (20cc total) blood samples in standard collection tubes will be obtained via venipuncture or a peripheral IV line from each enrolled patient at the time of enrollment.
- One sample will be collected in a lithium heparin tube and the other sample will be collected in an EDTA tube. Initial blood samples will be collected after the initiation of standard medical therapy and stabilization for acute heart failure.
- The blood samples will be analyzed for cardiac biomarkers such as BNP, high sensitivity troponins (hsTnI), endothelin-1 (ET-1), kidney injury molecule-1 (KIM-1) by Singulex, and adrenomedullin (hADM) by Sphingotec.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older.
- •Admitted with a clinical diagnosis of acute heart failure.
- •Evidence of congestion (rales, JVP, CXR, edema).
- •BNP >300pg/mL
- •If BMI >35 kg/m2, then BNP >100 pg/ml.
- •Consent within 24 hours of admission, but every attempt will be made to consent within six hours.
- •Patients with known sleep disordered breathing (SDB) can be included.
- •One-half of patients in each group will have chronic kidney disease (CKD) with GFR less than 60.
排除标准
- •Age < 18 years.
- •Unable to provide informed consent within 24 hours of admission.
- •Current participation in a pharmaceutical or treatment-related clinical study.
- •Hypercarbic (ie. Acute Respiratory Acidosis) from reasons other than acute heart failure.
- •Cardiogenic shock.
- •Clinical diagnosis of COPD exacerbation as the primary reason for hospital admission.
- •History of non-compliance to medications and treatment.
- •Pregnant women.
结局指标
主要结局
Change in Renal Biomarkers
时间窗: 30 days post-discharge
Mean paired change in measured blood urea nitrogen (BUN), serum creatinine (\> 0.3 mg/dL increase in 48 hours), neutrophil gelatinase-associated lipocalin (NGAL), Pro-encephalin (Penkid), and endothelin
次要结局
- Change in Renal Biomarkers(up to 90 days post-discharge)
- Reduction in Decrease of eGFR(up to 90 days post-discharge)
- Disposition and post-discharge composite events(up to 90 days post-discharge)
- Other markers of renal function(up to 90 days post-discharge)
研究者
Nancy Gardetto, Ph.D
Research Scientist
Veterans Medical Research Foundation