Systolic Heart Failure
Conditions
Keywords
systolic heart failure, udenafil, exercise capacity
Brief summary
The purpose of this study is to determine if udenafil improves exercise tolerance in patients with systolic heart failure.
Detailed description
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.
Interventions
DRUGPlacebo
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.
Sponsors
Dong-A Pharmaceutical Co., Ltd.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years of age, LV EF \< 40%
Exclusion criteria
* long-term use of medications that inhibit cytochrome P450 3A4. * inability patients with exercise test * primary pulmonary artery hypertension * severe hypotension (\< 90/50mmHg) or severe hypertension (\> 170/100mmHg)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO2max with cardiopulmonary exercise test | Baseline and 12th weeks | VO2 max was defined as cardiopulmonary exercise capacity Comparison between groups and within groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes of left ventricle ejection fraction | baseline and 12 th week | comparison between groups and within groups |
| serum BNP level | Baseline, 4th week, and 12th week | Comparison between groups and within groups |
| Change of ventilator efficiency (VE/VCO2 slope) in cardiopulmonary exercise test | Baseline and 12th week | Comparison between groups and within groups |
| Change of pulmonary artery systolic pressure (PASP) in echocardiography at rest and during exercise | Baseline and 12th week | Comparison between groups and within groups. |
| Safety endpoint | 12th week | 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. |
| Change of symptomatic status expressed as Borg dyspnea index | baseline, 4 weeks and 12 weeks | Comparison between groups and within groups. |
| Change of symptomatic status expressed as New York Heart Association (NYHA) functional class | Baseline, 4th week, and 12th week | Comparison between groups and within groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| All cause death, cardiac death, and heart failure-related admission and their composite | 12 week | All cause death, cardiac death, and heart failure-related admission and their composite |
Countries
South Korea
Outcome results
None listed