A Phase 3 interventional study of Placebo and Udenafil (Zydena) in Systolic Heart Failure, sponsored by Seoul National University Hospital. Terminated at 1 site in Korea, Republic of. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-04-24.
Sponsored by Seoul National University Hospital · Phase 3, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 41 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Capsule that is identically appearing with udenafil will be administered to patients in placebo group. For the first 4 weeks, patients will receive 50 mg of placebo drug two times a day, and then the dosage will be doubled to 100 mg two times a day for next 8 weeks.
Drug: Placebo
Patients will receive 50 mg of udenafil two times a day, and then the dosage will be doubled to 100 mg two times a day for next 8 weeks.
Drug: Udenafil (Zydena)
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.
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
Change of symptomatic status expressed as Borg dyspnea index
Comparison between groups and within groups.
Time frame: baseline, 4 weeks and 12 weeks
All cause death, cardiac death, and heart failure-related admission and their composite
All cause death, cardiac death, and heart failure-related admission and their composite
Time frame: 12 week
This study is terminated, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital