Systolic Heart FailurePhase 3ULTIMATE-SHFNCT01646515
Udenafil Therapy to Improve Symptomatology, Exercise Tolerance and Hemodynamics in Patients With Chronic Systolic Heart Failure
A Phase 3 study testing Udenafil (Zydena) in people with Systolic Heart Failure, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine if udenafil improves exercise tolerance in patients with systolic heart failure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Systolic Heart Failure
- What is being tested?
- Udenafil (Zydena)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Jan 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age, LV EF < 40%
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if udenafil improves exercise tolerance in patients with systolic heart failure.
Read the 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.
- Conditions
- Systolic Heart Failure
- Being tested
- Placebo, Udenafil (Zydena)
- Keywords
- systolic heart failure, udenafil, exercise capacity
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Placebo |
| 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. Receives: Drug: Udenafil (Zydena) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max with cardiopulmonary exercise test
VO2 max was defined as cardiopulmonary exercise capacity
Comparison between groups and within groups
Measured: Baseline and 12th weeks
Secondary outcomes (7)
The changes of left ventricle ejection fraction
comparison between groups and within groups
Measured: baseline and 12 th week
serum BNP level
Comparison between groups and within groups
Measured: Baseline, 4th week, and 12th week
Change of ventilator efficiency (VE/VCO2 slope) in cardiopulmonary exercise test
Comparison between groups and within groups
Measured: Baseline and 12th week
Change of symptomatic status expressed as New York Heart Association (NYHA) functional class
Comparison between groups and within groups
Measured: 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.
Measured: Baseline and 12th week
Safety endpoint
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.
Measured: 12th week
Change of symptomatic status expressed as Borg dyspnea index
Comparison between groups and within groups.
Measured: baseline, 4 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startDec 2011
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Substantial benefit was observed in the active treatment group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systolic Heart FailureStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Hyung-Kwan Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646515
- Sponsor's protocol ID
- H-1102-063-352
- Acronym
- ULTIMATE-SHF
- Status last verified
- Apr 2014
- First submitted
- 13 Jun 2012
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23799908
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Udenafil Therapy to Improve Symptomatology, Exercise Tolerance and Hemodynamics in Patients With Chronic Systolic Heart Failure
- ClinicalTrials.gov ID
- NCT01646515
- Acronym / sponsor ID
- ULTIMATE-SHF / H-1102-063-352
- Conditions
- Systolic Heart Failure
- Keywords
- systolic heart failure, udenafil, exercise capacity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Substantial benefit was observed in the active treatment group
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Dong-A Pharmaceutical Co., Ltd.
- Study start
- Dec 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo arm | Placebo comparator | Drug: PlaceboCapsule 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 | Drug: Udenafil (Zydena)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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥ 18 years of age, LV EF < 40%
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboCapsule, 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 | Drug | placebo arm |
| 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. | Drug | Udenafil |
Primary outcome
VO2max with cardiopulmonary exercise test
Time frame: Baseline and 12th weeks
VO2 max was defined as cardiopulmonary exercise capacity Comparison between groups and within groups
7 secondary outcomes
The changes of left ventricle ejection fraction
Time frame: baseline and 12 th week
serum BNP level
Time frame: Baseline, 4th week, and 12th week
Change of ventilator efficiency (VE/VCO2 slope) in cardiopulmonary exercise test
Time frame: Baseline and 12th week
Change of symptomatic status expressed as New York Heart Association (NYHA) functional class
Time frame: Baseline, 4th week, and 12th week
Change of pulmonary artery systolic pressure (PASP) in echocardiography at rest and during exercise
Time frame: Baseline and 12th week
Safety endpoint
Time frame: 12th week
Change of symptomatic status expressed as Borg dyspnea index
Time frame: baseline, 4 weeks and 12 weeks
Results and safety
The study was stopped early (reason given: Substantial benefit was observed in the active treatment group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
- Derived from this study: PubMed 23799908Kim 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Udenafil (Zydena) in people with Systolic Heart Failure, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Substantial benefit was observed in the active treatment group). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2max with cardiopulmonary exercise test (time frame: Baseline and 12th weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01646515, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.