The Use of Nesiritide in the Management of Acute Diastolic Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 主要终点
- Effectiveness of nesiritide in improving symptoms, including pressure in heart and lungs, related to diastolic heart failure (condition where heart muscle is stiff and not able to relax completely, causing the pressures in heart to increase).
研究概览
简要总结
Primary objective is to assess the effect of nesiritide in decreasing left ventricular (LV) filling pressure, defined as pulmonary artery capillary wedge pressure (PCWP) in a group of patients admitted with acute diastolic heart failure.
Secondary objectives include: improvement in symptoms, exercise tolerance, improvement in Doppler diastolic filling parameters in patients with diastolic heart failure.
详细描述
Patients with diastolic heart failure often have high pressure in their heart and lungs and many symptoms such as shortness of breath, low energy, fluid retention, and fatigue. Decreasing the pressure in the heart and lungs may help these patients feel better. The drug nesiritide was designed to help treat heart failure. It has also been shown to help decrease the pressure in the lungs.
Before treatment starts, you will be asked questions about your medical history and about any medications you are currently taking. You will have a complete physical exam. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart) and routine blood tests (about 2 teaspoons). You will have an ultrasound on your heart called an echocardiogram to measure your heart function and the pressures in your lungs. Your ability to breathe will be evaluated. With the aid of the research nurse, you will have a 6-minute walk test. You may stop or sit down at any time during the test. This test is being done to evaluate your energy level. You will also be asked to complete a questionnaire about your symptoms. This questionnaire should take no more than 10 minutes to complete.
In order to measure the pressure in your heart and lungs, you will have a procedure called a "right heart catheterization". This is a procedure that may have been done as part of your standard of care even if you were not enrolled in this study. For this procedure, a small tube will be placed in a vein in your neck. A longer tube will be inserted into the first tube and fed through the vein and into your heart. This tube will be used to measure the pressure in your heart and lungs. After the pressures are measured, you will receive treatment with nesiritide during the right heart catheterization procedure.
Nesiritide will be given as a continuous infusion (for 48 hours) by vein. The pressures in your heart and lungs will be measured again at 15, 30, then 60 minutes after you begin to receive nesiritide. The tubes will then be removed from your heart. You will be awake during this procedure and lying flat on your back. An anesthetic will be used to numb the area of your neck where the tube is placed. The entire procedure (including treatment) should take no longer than 1 hour. You will have an ultrasound of your heart performed immediately before and after the right heart catheterization.
Within 15 minutes of the end of the procedure the echocardiogram, the 6-minute walk test, and the questionnaire about your symptoms will be repeated and your breathing will be re-evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 85 years old
- •Admitted with acute heart failure determined by: symptoms of fatigue; shortness of breath; edema; physical evidence of volume overload; and/or pulmonary edema by CXR
- •LVEF > or = 40% on recent (< or = 1 month) echo or MUGA
- •NYHA class III or IV on admission
- •Baseline systolic blood pressure > 90 mm Hg
- •Baseline BNP level > 100 pg/ml
- •Able to sign informed consent and return for follow-up assessments
排除标准
- •Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) <90 mm Hg)
- •Active infection/sepsis as defined by fever > 101.5 F, currently on IV antibiotics
- •Creatinine greater than 3.0 mg/dl
- •LV ejection fraction < 40% (must be done within the last 30 days prior to signing consent)
- •Significant valvular disease or constrictive cardiomyopathy
- •Severe Thrombocytopenia (as defined by platelets less than 20,000) or INR > 1.6
- •Hypersensitivity to nesiritide or any of its components.
- •Pulmonary capillary wedge pressure (PCWP) <16 mmHg
- •If patient is of child-bearing age, a pregnancy test will be performed, and the patient is excluded if pregnancy test is positive.
研究组 & 干预措施
1
Nesiritide
干预措施: Nesiritide (Drug)
结局指标
主要结局
Effectiveness of nesiritide in improving symptoms, including pressure in heart and lungs, related to diastolic heart failure (condition where heart muscle is stiff and not able to relax completely, causing the pressures in heart to increase).
时间窗: 2 Years
次要结局
未报告次要终点