Udenafil Therapy to Improve Symptomatology, Exercise Tolerance and Hemodynamics in Patients With Chronic Systolic Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- VO2max with cardiopulmonary exercise test
研究概览
简要总结
The purpose of this study is to determine if udenafil improves exercise tolerance in patients with systolic heart failure.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age, LV EF < 40%
排除标准
- •long-term use of medications that inhibit cytochrome P450 3A
- •inability patients with exercise test
- •primary pulmonary artery hypertension
- •severe hypotension (< 90/50mmHg) or severe hypertension (> 170/100mmHg)
研究组 & 干预措施
placebo arm
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.
干预措施: Placebo (Drug)
Udenafil
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.
干预措施: Udenafil (Zydena) (Drug)
结局指标
主要结局
VO2max with cardiopulmonary exercise test
时间窗: Baseline and 12th weeks
VO2 max was defined as cardiopulmonary exercise capacity Comparison between groups and within groups
次要结局
- serum BNP level(Baseline, 4th week, and 12th week)
- The changes of left ventricle ejection fraction(baseline and 12 th week)
- Change of ventilator efficiency (VE/VCO2 slope) in cardiopulmonary exercise test(Baseline and 12th week)
- Change of symptomatic status expressed as New York Heart Association (NYHA) functional class(Baseline, 4th week, and 12th week)
- Change of pulmonary artery systolic pressure (PASP) in echocardiography at rest and during exercise(Baseline and 12th week)
- Safety endpoint(12th week)
- Change of symptomatic status expressed as Borg dyspnea index(baseline, 4 weeks and 12 weeks)
研究者
Hyung-Kwan Kim
Associate Professor
Seoul National University Hospital