ULTIMATE-SHF: Udenafil Therapy to Improve Symptomatology, Exercise Tolerance and Hemodynamics in Patients With Chronic Systolic Heart Failure
Study Details
Study Description
Brief Summary
The purpose of this study is to determine if udenafil improves exercise tolerance in patients with systolic heart failure.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: 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. |
Drug: Placebo
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
|
| Active Comparator: 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. |
Drug: Udenafil (Zydena)
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.
|
Outcome Measures
Primary Outcome Measures
- VO2max with cardiopulmonary exercise test [Baseline and 12th weeks]
VO2 max was defined as cardiopulmonary exercise capacity Comparison between groups and within groups
Secondary Outcome Measures
- 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 symptomatic status expressed as New York Heart Association (NYHA) functional class [Baseline, 4th week, 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: Development of facial flushing, febrile sensation, eyeball pain, visual disturbance, headache, penile erection. 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.
Other Outcome Measures
- 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
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of | 110-744 |
Sponsors and Collaborators
- Seoul National University Hospital
- Dong-A Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-1102-063-352