A Randomized Controlled Pilot Study for Assessment of Coronary Flow Reserve With Cardiac PET Imaging in Acute Decompensated Heart Failure Patients Treated With Diuretics Versus Ultrafiltration
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Myocardial Blood Flow
研究概览
简要总结
The purpose of this research study is to compare the effects (good and bad) of ultrafiltration treatment with standard intravenous (in your vein) diuretic therapy (furosemide, torsemide, bumetanide) on your heart function and blood flow.
详细描述
The standard of care to treat congestive heart failure is with a class of medication called diuretics, which remove the extra fluid from the body through urination. Another way to remove extra fluid in patients with heart failure is called ultrafiltration. Ultrafiltration may result in more rapid removal of excess fluid and more rapid improvement in your symptoms compared to standard diuretic treatment. Currently, it is unknown what effects these therapies (diuretics or ultrafiltration) have on the small blood vessels in your heart. These small blood vessels are important to supply blood and oxygen to your failing heart. Thus, the purpose of this research study is to compare the effects (good and bad) of ultrafiltration treatment with standard intravenous (in your vein) diuretic therapy on your heart function and blood flow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
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
- •males and non-pregnant female patients over 18 years admitted to the hospital or treated in an outpatient heart failure clinic with the primary diagnosis of acute decompensated heart failure.
- •evidence of fluid overload more than 8 kg above their dry weight, and conforming to definition of hypervolemia (at least two of the following findings: more than 1+ pitting edema of the lower extremities, jugular venous pressure more than 10 cm water, pulmonary edema or pleural effusion on chest radiograph consistent with ADHF, ascites, paroxysmal nocturnal dyspnea, or equal or more than 2 pillow orthopnea.
排除标准
- •acute coronary syndrome
- •documented ischemic cardiomyopathy
- •atrial fibrillation
- •serum creatinine more than 3.0 mg/dL
- •systolic blood pressure less than 90 mmHg
- •hematocrit > 45%
- •clinical instability likely to require intravenous vasopressors and/or intravenous vasoactive drugs (such as milrinone, dobutamine, nitroglycerin or nesiritide) during the present hospitalization
- •severe pulmonary hypertension or use of pulmonary hypertension drugs (such as sildenafil, bosentan or other endothelin inhibitors)
- •patients with documented hypertrophic obstructive cardiomyopathy or restrictive cardiomyopathy,
- •patients with severe valvular heart disease,
- •patients with recent cocaine use (within one month of presentation)
- •patients with heart transplant
- •patients with systemic infection
- •patients on hemodialysis
- •inability to obtain venous access
- •contraindications for anticoagulation
- •unable to lie flat for at least 20 minutes
- •pregnant and breast-feeding women.
研究组 & 干预措施
Ultrafiltration
Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics (loop diuretics: furosemide, bumetanide, and/or torsemide). Patients in this arm are randomized to ultrafiltration.
干预措施: Ultrafiltration (Other)
Diuretic Therapy
Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy ((loop diuretics: furosemide, bumetanide, and/or torsemide). The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy with either furosemide, bumetanide, and/or torsemide.
干预措施: Loop diuretics (furosemide, torsemide, bumetanide) (Drug)
结局指标
主要结局
Myocardial Blood Flow
时间窗: 1 - 5 days
Evaluate the effects of ultrafiltration (UF) compared to intravenous diuretic therapy on myocardial blood flow (MBF) and coronary flow reserve (CFR), as assessed by positron emission tomography (PET), in patients with acutely decompensated heart failure (ADHF).
次要结局
未报告次要终点
研究者
Myron C. Gerson
MD
University of Cincinnati