Assessment of clinical effect and treatment quality of immediate release carvedilol (IR) versus slow release carvedilol (SR) in patients with HFrEF
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
320
patients will receive slow-release carvedilol (SR) once daily
patients will receive immediate release carvedilol (IR) twice daily
Sejong Hospital
Gyeonggi-do, Bucheon, South Korea
RECRUITINGGangdong Sacred Heart Hospital
Seoul, Gangdong, South Korea
NT-proBNP
Change of NT-proBNP from baseline to 6 months after randomization
Time frame: 6 months
All-cause Death
Difference in all-cause deaths between the groups during clinical follow-up
Time frame: 6 months
Hospitalization
Difference in hospitalization for heart failure between the groups during clinical follow-up
Time frame: 6 months
Blood Pressure
Difference in blood pressure change between the groups during clinical follow-up
Time frame: 6 months
Dyspnea
Differences in dyspnea measured with visual analogue scale between the groups during clinical follow-up
Time frame: 6 months
Drug compliance
Differences in drug compliance measured with 'pill-count' between the groups during clinical follow-up
Time frame: 6 months
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Korea Univ. Guro Hospital
Seoul, Guro, South Korea
RECRUITINGSamsung Medical Center
Seoul, Il-won, South Korea
RECRUITINGSeoul Medical Center
Seoul, Jungnang, South Korea
RECRUITINGKorea Univ. Anam Hospital
Seoul, Seongbuk, South Korea
RECRUITINGAsan Medical Center
Seoul, Songpa, South Korea
RECRUITINGAjou Univ. Medical Center
Suwon, Yeong-tong, South Korea
RECRUITINGSeoul National University Bundang Hospital
Seongnam, South Korea
RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITING...and 3 more locations