Randomized Evaluation of Heart Failure With Preserved Ejection Fraction (HFpEF) Patients With Acute Heart Failure and Dopamine (ROPA-DOP) Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Percent Change in Serum Creatinine at 72 Hours - Dopamine vs No Dopamine
研究概览
简要总结
Heart Failure with preserved Ejection Fraction (HFPEF) accounts for 40-50% of all heart failure patients with a frequency of hospital admissions for acute decompensation and short and long term mortality similar to patients with heart failure with reduced ejection fraction (HFREF). Patients with HFPEF are often preload dependent and despite admission to the hospital for acute decompensated heart failure (ADHF), are typically difficult to diurese due to the development of acute kidney injury. No studies have been performed evaluating treatment strategies for these patients. The investigators hypothesize that changing the method of diuresis and/or the addition of low-dose dopamine for the treatment of ADHF in patients with HFPEF will reduce renal injury, resulting in a shorter length of stay, and decrease hospital readmissions over the ensuing year. This trial will randomize patients to either bolus or continuous infusion furosemide and then to either dopamine or no dopamine. The primary endpoint will be renal function at 72 hours as measured by change in Glomerular Filtration Rate (GFR). Secondary endpoints for readmission, functional capacity, quality of life, and amount of diuresis will also be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Admission to Johns Hopkins Hospital for acute decompensated heart failure.
- •Patient ≥18 years of age
- •Estimated GFR of > 15 milliliters/min/1.73m2 determined by the Modification of Diet in Renal Disease (MDRD) equation
- •Willingness to provide informed consent
- •Known ejection fraction by noninvasive testing of > 50% within 12 months of admission to the hospital with no interval myocardial infarction since inclusion transthoracic echo, by history, or by ECG.
- •Negative pregnancy test in a female of child bearing potential
- •Willingness of primary attending physician for patient to participate.
排除标准
- •Systolic BP <90 mmHg on admission
- •Hemoglobin (Hgb) < 8 g/dl
- •Known allergy or intolerance to furosemide or low dose dopamine.
- •Hemodynamically significant arrhythmias including ventricular tachycardia or defibrillator shock within 4 weeks
- •Acute coronary syndrome within 4 weeks
- •Cardiac diagnoses in addition to or other than HFpEF:
- •i. Active myocarditis ii. Hypertrophic obstructive cardiomyopathy iii. Severe valvular disease iv. Restrictive or constrictive cardiomyopathy, including known amyloidosis, sarcoidosis, hemachromatosis v. Complex congenital heart disease vi. Constrictive pericarditis vii. Severe pulmonary hypertension (RVSP ≥ 60), not secondary to HFpEF
- •Non-cardiac pulmonary edema
- •Clinical evidence of digoxin toxicity
- •Received IV vasoactive treatment or ultra-filtration therapy for heart failure since initial presentation
- •Anticipated need for IV vasoactive treatment or ultra-filtration for heart failure during this hospitalization
- •History of temporary or permanent renal replacement therapy or ultrafiltration
- •History of renal artery stenosis > 50%
- •Need for mechanical hemodynamic support
- •Terminal illness (other than HF) with expected survival of less than 1 year
- •Previous adverse reaction to the study drugs
- •Use of IV iodinated contrast material/dye 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
- •Pregnancy or nursing mothers
研究组 & 干预措施
Bolus furosemide and no dopamine
If the patient is not on a prior diuretic dose, a standard dose of furosemide 40mg IV every 12 hrs, with total dose of 80 mg IV over 24 hrs will be initiated.
If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose every 12 hrs. (i.e if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose will be furosemide 80mg IV twice daily).
干预措施: Furosemide (Drug)
Continuous infusion furosemide and no dopamine
If the patient is not on a prior diuretic dose, a standard dose of furosemide 80mg IV over 24 hrs, will be initiated.
If the patient is already on a prescribed diuretic dose, their outpatient dose will be doubled and administered as the equivalent IV dose continuously over 24 hrs. . (i.e. if the prescribed dose is furosemide 80mg by mouth twice daily, the inpatient treatment dose would be furosemide 160mg IV to be administered continuously over 24 hrs).
干预措施: Furosemide (Drug)
Bolus furosemide plus dopamine
Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min
干预措施: Furosemide (Drug)
Bolus furosemide plus dopamine
Intermittent furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min
干预措施: Dopamine (Drug)
Continuous furosemide plus dopamine
Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min
干预措施: Furosemide (Drug)
Continuous furosemide plus dopamine
Continuous furosemide diuretic therapy as outlined with the addition of dopamine at 3 µg/kg/min
干预措施: Dopamine (Drug)
结局指标
主要结局
Percent Change in Serum Creatinine at 72 Hours - Dopamine vs No Dopamine
时间窗: 72 hours
Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation by dopamine strategy
Percent Change in Serum Creatinine at 72 Hours - Continuous vs Intermittent Diuretic
时间窗: 72 hours
Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation by diuretic strategy
Percent Change in Serum Creatinine at 72 Hours.
时间窗: 72 hours
Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation.
次要结局
未报告次要终点