The purpose of this study is to determine if udenafil improves exercise tolerance in patients with systolic heart failure.
Udenafil (Zydena), a newly developed PDE-5 inhibitor, has been proved to have similar efficacy and safety profile, compared with other PDE-5 inhibitors. Also, laboratory data showed that udenafil inhibits ventricular hypertrophy and fibrosis in rat heart failure model. Based on these results, the investigators hypothesized that udenafil would improve symptom, exercise capacity and hemodynamic status in patients with systolic heart failure. In this 12-week, randomized, double-blind, placebo-controlled trial, patients with systolic heart failure will be enrolled according to the eligibility criteria. After randomization, study participants will be assigned to receive either 50mg of udenafil or placebo two times a day for 4 weeks, and then the dosage will be doubled to 100mg two times a day for next 8 weeks. Participants will attend study visits at baseline and weeks 4 and 12. Physical examination, medical history review, blood sample collection and electrocardiogram will be conducted on each study visits. At baseline and week 12, participants will undergo cardiopulmonary exercise test and exercise echocardiography. At every study visits,researchers will collect health information.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
41
Capsule, appears identical with udenafil, will be provided by Dong-A pharmaceutical company. Patients will receive 50 mg of placebo drug two times a day for 4 weeks, and then the dosage will be escalated to 100 mg two times a day for next 8 weeks
Udenafil (Zydena), a newly developed PDE-5 inhibitor by Dong-A pharmaceutical company, will be administered to patients in this group, 50 mg two times a day for 4 weeks, and then the dosage will be escalated to 100 mg two times a day for next 8 weeks.
Seoul National University Hospital
Seoul, South Korea
VO2max with cardiopulmonary exercise test
VO2 max was defined as cardiopulmonary exercise capacity Comparison between groups and within groups
Time frame: Baseline and 12th weeks
The changes of left ventricle ejection fraction
comparison between groups and within groups
Time frame: baseline and 12 th week
serum BNP level
Comparison between groups and within groups
Time frame: Baseline, 4th week, and 12th week
Change of ventilator efficiency (VE/VCO2 slope) in cardiopulmonary exercise test
Comparison between groups and within groups
Time frame: Baseline and 12th week
Change of symptomatic status expressed as New York Heart Association (NYHA) functional class
Comparison between groups and within groups
Time frame: Baseline, 4th week, and 12th week
Change of pulmonary artery systolic pressure (PASP) in echocardiography at rest and during exercise
Comparison between groups and within groups.
Time frame: Baseline and 12th week
Safety endpoint
Safety endpoint during 12 week follow-up, is defined as follows: 1. Development of facial flushing, febrile sensation, eyeball pain, visual disturbance, headache, penile erection. 2. Intolerance or development of other adverse drug reactions related with study drug.
Time frame: 12th week
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Change of symptomatic status expressed as Borg dyspnea index
Comparison between groups and within groups.
Time frame: baseline, 4 weeks and 12 weeks