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Substantial benefit was observed in the active treatment group
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| Name | Class |
|---|---|
| Dong-A Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo arm | Placebo Comparator | 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. |
|
| Udenafil | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| VO2max with cardiopulmonary exercise test | VO2 max was defined as cardiopulmonary exercise capacity Comparison between groups and within groups | Baseline and 12th weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of left ventricle ejection fraction | comparison between groups and within groups | baseline and 12 th week |
| serum BNP level | Comparison between groups and within groups |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 week |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23799908 | Derived | Kim KH, Kim HK, Hwang IC, Lee SP, Cho HJ, Kang HJ, Kim YJ, Sohn DW. ULTIMATE-SHF trial (UdenafiL Therapy to Improve symptoMAtology, exercise Tolerance and hEmodynamics in patients with chronic systolic heart failure): study protocol for a randomized, placebo-controlled, double-blind trial. Trials. 2013 Jun 22;14:188. doi: 10.1186/1745-6215-14-188. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 20, 2015 | |
| Reset | Jun 5, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 20, 2015 | Jun 5, 2015 |
| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C419664 | udenafil |
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| Udenafil (Zydena) | Drug | 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. |
|
| Baseline, 4th week, and 12th week |
| Change of ventilator efficiency (VE/VCO2 slope) in cardiopulmonary exercise test | Comparison between groups and within groups | Baseline and 12th week |
| Change of symptomatic status expressed as New York Heart Association (NYHA) functional class | Comparison between groups and within groups | 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. | Baseline and 12th week |
| Safety endpoint | Safety endpoint during 12 week follow-up, is defined as follows:
| 12th week |
| Change of symptomatic status expressed as Borg dyspnea index | Comparison between groups and within groups. | baseline, 4 weeks and 12 weeks |