Immediate Release Versus Slow Release Carvedilol in Heart Failure
- Conditions
- Heart Failure With Reduced Ejection Fraction
- Interventions
- Drug: CarVeDilol-SR (Slow Release)
- Registration Number
- NCT03209180
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Assessment of clinical effect and treatment quality of immediate release carvedilol (IR) versus slow release carvedilol (SR) in patients with HFrEF
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 320
Not provided
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carvedilol IR (Immediate Release) Carvedilol IR (Immediate Release) Carvedilol IR 3.125mg, 6.25mg, 12.5mg, 25mg twice daily p.o. for 6 months CarVeDilol-SR (Slow Release) CarVeDilol-SR (Slow Release) CarVeDilol-SR 8mg, 16mg, 32mg, 64mg once daily p.o. for 6 months
- Primary Outcome Measures
Name Time Method NT-proBNP 6 months Change of NT-proBNP from baseline to 6 months after randomization
- Secondary Outcome Measures
Name Time Method Dyspnea 6 months Differences in dyspnea measured with visual analogue scale between the groups during clinical follow-up
All-cause Death 6 months Difference in all-cause deaths between the groups during clinical follow-up
Hospitalization 6 months Difference in hospitalization for heart failure between the groups during clinical follow-up
Blood Pressure 6 months Difference in blood pressure change between the groups during clinical follow-up
Drug compliance 6 months Differences in drug compliance measured with 'pill-count' between the groups during clinical follow-up
Trial Locations
- Locations (13)
Korea Univ. Guro Hospital
🇰🇷Seoul, Guro, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Il-won, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Songpa, Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Sejong Hospital
🇰🇷Gyeonggi-do, Bucheon, Korea, Republic of
Gangdong Sacred Heart Hospital
🇰🇷Seoul, Gangdong, Korea, Republic of
Korea Univ. Anam Hospital
🇰🇷Seoul, Seongbuk, Korea, Republic of
Ajou Univ. Medical Center
🇰🇷Suwon-si, Yeong-tong, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Seoul Medical Center
🇰🇷Seoul, Jungnang, Korea, Republic of