Assessment of Clinical Effect and Treatment Quality of Rapid Release Carvedilol Versus SLOW Release Carvedilol-SR in HEART FAILURE Patient (SLOW-HF): A Prospective Randomized, Open-label, Multicenter Study
试验速览
- 阶段
- 4 期
- 入组人数
- 320
- 试验地点
- 13
- 主要终点
- NT-proBNP
研究概览
简要总结
Assessment of clinical effect and treatment quality of immediate release carvedilol (IR) versus slow release carvedilol (SR) in patients with HFrEF
详细描述
The SLOW-HF trial is a phase 4, randomized, open label, multicenter study to evaluate the therapeutic efficacy of carvedilol-SR compared to carvedilol-IR in patients with heart failure with reduced ejection fraction. Patients with stable HFrEF will be randomly assigned (1:1) to carvedilol SR group (160 patients) and carvedilol IR group (160 patients).
After randomization, patients will be followed for 6 months. The primary endpoint is the change in NT-proBNP level from baseline to the study end. The secondary endpoints include the frequency of NT-proBNP increment >10% from baseline, composite of all-cause mortality and readmission, mortality rate, readmission rate, changes in blood pressure, quality of life, and drug compliance.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Systolic blood pressure at sitting position < 90mmHg or resting heart rate < 50 /min at screening
- •Patient has a contraindication to β-blockers
- •Patient who are expected to take another β-blocker after randomization
- •Cardiovascular diseases
- •Ischemic heart disease (unstable angina, myocardial infarction) within 1 month
- •Hypertrophic cardiomyopathy
- •Cor pulmonale
- •Hemodynamically significant stenosis of aorta, aortic valve, or mitral valve
- •any acute myocardial infarction with complication
- •Severe cerebrovascular accident (for example, ischemic stroke or cerebral hemorrhage) pre-analytical within 6 months
- •Glottis edema, allergic rhinitis, respiratory diseases with bronchospasm such as asthma and chronic obstructive lung disease
- •Peripheral vascular disease (for example, Raynaud syndrome, intermittent claudication)
- •Patients who need vasopressor due to prominent volume retention/overload
- •Moderate to Severe retinopathy (for example, retinal hemorrhage, visual disturbance, retinal microaneurysm within 6 months)
- •Impaired renal function (Serum creatinine ≥ 2.5 mg/dL) or hepatic function (AST or ALT ≥ 3 x ULM)
- •Patients in clinical status that can significantly influence on absorption, distribution, metabolism, and secretion of drugs for clinical trial
- •history of major gastrointestinal surgery, such as gastrectomy or gastric bypass surgery
- •inflammatory bowel disease within 12 months
- •current gastric ulcer, pancreatic function abnormality including pancreatitis, gastrointestinal/rectal bleeding which demand treatment
- •current urologic stenosis or obstruction which demand treatment
- •Confirmed or suspected drug/alcohol abuse within 6 months
- •Pregnant or lactating women, suspected pregnant women or lactating women
- •Chronic inflammatory diseases which demand anti-inflammatory treatment
- •Hypersensitivity to carvedilol
- •Malignant disease including lymphoma and leukemia within 5 years
- •Patients who were prescribed other medication for any clinical trials pre-analytical within 28 days
- •Patients who are predicted to have prolonged hospital days due to other medical problems other than chronic heart failure (for example, femur neck fracture)
- •Patients who are considered as inappropriate to participate in the clinical trial by testers
研究组 & 干预措施
Carvedilol IR (Immediate Release)
Carvedilol IR 3.125mg, 6.25mg, 12.5mg, 25mg twice daily p.o. for 6 months
干预措施: Carvedilol IR (Immediate Release) (Drug)
CarVeDilol-SR (Slow Release)
CarVeDilol-SR 8mg, 16mg, 32mg, 64mg once daily p.o. for 6 months
干预措施: CarVeDilol-SR (Slow Release) (Drug)
结局指标
主要结局
NT-proBNP
时间窗: 6 months
Change of NT-proBNP from baseline to 6 months after randomization
次要结局
- Dyspnea(6 months)
- All-cause Death(6 months)
- Hospitalization(6 months)
- Blood Pressure(6 months)
- Drug compliance(6 months)
研究者
Dong-Ju Choi
Professor, MD, PhD
Seoul National University Bundang Hospital