Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure (AVOID-HF)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 224
- 试验地点
- 38
- 主要终点
- Time to First Heart Failure (HF) Event
研究概览
简要总结
The purpose of the research is to determine if patients have fewer Heart Failure (HF) events after receiving Aquapheresis (AQ) therapy compared to intravenous (IV) diuretics up to 90 days of discharge from the hospital. Heart Failure events are defined as returning to the hospital, clinic or emergency department (ED) for treatment of HF symptoms.
详细描述
The aim of the proposed AVOID-HF study is to confirm and expand the findings that fluid removal by AQ reduces HF rehospitalizations at 90 days as well as the length of these HF rehospitalizations. In the "Ultrafiltration Versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure" (UNLOAD) study, the 90 day HF re-hospitalizations were pre-specified secondary end-points. AVOID-HF is designed with a primary end-point to determine if AQ reduces the number of HF events (Rehospitalization or unscheduled outpatient or emergency room treatment for HF) after discharge from index hospitalization compared to IV loop diuretics. AVOID will also explore days alive and out of the hospital as a secondary end-point, which was not done in UNLOAD. In other words, the AVOID-HF study is going beyond studying only the amount of fluid removal and will explore whether the modality of fluid removal influences HF outcomes.
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
- •18 years of age or older
- •Male or non-pregnant female patients
- •Admitted to the hospital with a primary diagnosis of acute decompensated heart failure (ADHF)
- •On regularly scheduled oral loop diuretics prior to admission
- •Fluid overload manifested by at least two of the following:
- •Pitting edema (2+) of the lower extremities
- •Jugular venous distention > 8 cm
- •Pulmonary edema or pleural effusion on chest x-ray
- •Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea
- •Respiration rate ≥ 20 per minute.
- •Have received ≤ 2 IV loop diuretics doses before randomization
- •Must be able to be enrolled into the trial ≤ 24 hours of their admission to the hospital.
- •Provide written informed consent form as required by the local IRB (Institutional Review Board)
排除标准
- •Acute coronary syndromes
- •Renal insufficiency with a sCr ≥ 3.0 mg/dl or planned renal replacement therapies
- •Systolic blood pressure < 90 mmHg at time of enrollment
- •Pulmonary Arterial Hypertension not secondary to left heart disease
- •Contraindications to systemic anticoagulation
- •Hematocrit > 45%
- •Inability to obtain venous access
- •Hemodynamic instability severe enough to require IV positive inotropic agents, IV vasodilators or both
- •Use of iodinated radiocontrast material within the previous 72 hours or planned study requiring IV contrast during the current hospitalization
- •Severe concomitant disease expected to prolong hospitalization
- •Severe concomitant disease expected to cause death in ≤ 90 days
- •Sepsis or ongoing systemic infection
- •Severe uncorrected valvular stenosis
- •Active myocarditis
- •Hypertrophic obstructive cardiomyopathy
- •Constrictive pericarditis or restrictive cardiomyopathy
- •Liver cirrhosis
- •Previous solid organ transplant
- •Requirement for mechanical ventilatory support
- •Presence of a mechanical circulatory support device
- •Unwillingness or inability to complete follow up
- •Active drug or ETOH substance abuse
- •Participating in another interventional clinical trial
研究组 & 干预措施
Aquapheresis (AQ) - isolated veno-venous ultrafiltration
Excess fluid from the patient is removed by isolated veno-venous ultrafiltration treatment using the Aquadex Flex Flow System
干预措施: Isolated veno-venous ultrafiltration (AQ) (Device)
IV Loop Diuretics (LD)
Excess fluid from the patient is removed by IV (Intravenous) loop diuretic treatment
干预措施: IV Loop Diuretics (LD) (Drug)
结局指标
主要结局
Time to First Heart Failure (HF) Event
时间窗: 90 days after discharge from index HF hospitalization.
Time to first HF event within 90 days after discharge from index HF hospitalization. HF events are defined as * HF rehospitalization or * unscheduled outpatient or emergency room treatment with IV loop diuretics or * unscheduled outpatient Aquapheresis treatment
次要结局
- CLINICAL: Total Number of Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge(Within 30 days and 90 days after hospital discharge)
- EFFICACY: Net Fluid Removed During the Index Hospitalization(Index Hospitalization, an average of 8 days)
- EFFICACY: Total Fluid Removed During the Index Hospitalization(Index Hospitalization, an average of 8 days)
- EFFICACY: Changes in B-type Natriuretic Peptide (BNP) Levels Over Time(Baseline and at 72 hours from baseline, hospital discharge and at 90 days after hospital discharge)
- EFFICACY: Weight Loss at 72 Hours After Initiation of Treatment(72 hours after treatment initiation)
- Length of Stay (LOS) During the Index Hospitalization(Index hospitalization admission to index hospitalization discharge)
- CLINICAL: Total Number of Emergency Department (ED) or Unscheduled Office Visits at 30 and 90 Days After Discharge(Within 30 days and 90 days after hospital discharge)
- Quality of Life Assessed Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30, 60 and 90 Days After Discharge(Within 90 days after hospital discharge)
- SAFETY: Changes in Renal Function (Serum Creatinine) After Treatment up to 90 Days After Randomization(Within 90 days of randomization)
- SAFETY: Changes in Renal Function (Blood Urea Nitrogen) After Treatment up to 90 Days After Randomization(Within 90 days of randomization)
- SAFETY: Changes in Renal Function (Estimated Glomerular Filtration Rate) After Treatment up to 90 Days After Randomization(Within 90 days of randomization)
- EFFICACY: Total Weight Loss During the Index Hospitalization(Index Hospitalization, an average of 8 days)
- EFFICACY: Time to Freedom From Congestion(Index Hospitalization, an average of 8 days)
- EFFICACY: Freedom From Congestion(Index Hospitalization, an average of 8 days)
- CLINICAL: Total Number of Days Rehospitalized for Heart Failure (HF) at 30 and 90 Days After Discharge(Within 30 days and 90 days after hospital discharge)
- CLINICAL: Total Number of Heart Failure (HF) Rehospitalizations at 30 and 90 Days After Discharge(Within 30 days and 90 days after hospital discharge)
- CLINICAL: All Cause Rehospitalization Rates at 30 and 90 Days(Within 30 days and 90 days after hospital discharge)
- Days Alive and Out of Hospital at 30 and 90 Days After Discharge(Within 30 and 90 days after hospital discharge)
- CLINICAL: Total Number of Days for Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge(Within 30 days and 90 days after hospital discharge)
- Mortality Rates Within Index Hospitalization or Within 90 Days After Hospital Discharge.(Time from randomization to 90 days post-hospital discharge)
- SAFETY: Changes in Renal Function (Blood Urea Nitrogen/Serum Creatinine) After Treatment up to 90 Days After Randomization(Within 90 days of randomization)
- CLINICAL: Global Clinical Score at 30 and 90 Days After Discharge(Within 90 days after hospital discharge)