A Phase 3 interventional study of Placebo and Udenafil (Zydena) in Diastolic Heart Failure, sponsored by Seoul National University Hospital. Status unknown at 2 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-31.
Sponsored by Seoul National University Hospital · Phase 3, Interventional, and Treatment
The investigators hypothesized that udenafil, a newly developed phosphodiesterase type 5 inhibitor, would improve symptom, exercise capacity and hemodynamic status in patients with heart failure with preserved ejection fraction (HFpEF).
Heart failure with preserved ejection fraction (HFpEF) had been considered as a milder form of heart failure until 1990's. However, the prevalence and the prognosis of HFpEF were found to be similar to that of heart failure with reduced ejection fraction (HFrEF) and it is widely accepted that HFpEF is a separate entity of heart failure, substantially different from HFrEF. The pathophysiology of HFpEF can be contracted to the increased stiffness and impaired relaxation of left ventricle (LV), causing increased LV end-diastolic pressure and pulmonary venous pressure. These may lead to dyspnea, limited exercise capacity, and pulmonary congestion in patients.
Current guidelines on treatment of HFpEF include appropriate blood pressure control, rate control in those with atrial fibrillation, and use of diuretics for pulmonary or peripheral edema. But there has been no evidence-based effective treatment strategy for HFpEF. Recently, phosphodiesterase type 5 (PDE-5) inhibitors (eg. sildenafil, vardenafil, tadalafil) have shown promising effects on heart failure, reducing pulmonary vascular resistance, improving LV systolic and diastolic function, exercise capacity and quality of life. These results infer that PDE-5 inhibitors might be beneficial in patients with HFpEF.
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, we hypothesized that udenafil would improve symptom, exercise capacity and hemodynamic status in patients with HFpEF.
In this 12-week, randomized, double-blind, placebo-controlled trial, patients with HFpEF 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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 52 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Has experienced at least one of the following in the 12 months before study entry
Exclusion Criteria:
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
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)
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.
Also known as: The same placebo drug of NCT01553721.
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.
Also known as: DA-8159 (CAS No 268203-93-6)
Change of maximal VO2 in cardiopulmonary exercise test
Comparison between groups and within groups.
Time frame: Baseline and 12th weeks
Change of ventilator efficiency (VE/VCO2 slope) in cardiopulmonary exercise test
Comparison between groups and within groups.
Time frame: Baseline and 12th week
Change of symptomatic status expressed as New York Heart Association (NYHA) functional class
Comparison between groups and within groups.
Time frame: Baseline, 4th week, and 12th week
Change of symptomatic status expressed as Borg dyspnea index
Comparison between groups and within groups.
Time frame: 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.
Time frame: Baseline and 12th week
Change of left ventricular systolic function expressed as ejection fraction (EF), fractional shortening (FS) in echocardiography
Comparison between groups and within groups.
Time frame: Baseline and 12th week
Change of left ventricular diastolic function expressed as E velocity, E' velocity, E/E' ratio, E/A ratio
Comparison between groups and within groups.
Time frame: Baseline and 12th week
Change of left atrial volume
Comparison between groups and within groups.
Time frame: Baseline and 12th week
Change of plasma concentration of BNP
Comparison between groups and within groups.
Time frame: Baseline, 4th week, and 12th week
All-cause death
The occurrence of all-cause mortality during 12 week follow-up
Time frame: 12th week
Cardiac death
The occurrence of cardiac death including sudden cardiac death during 12 week follow-up
Time frame: 12th week
Admission for heart failure
Admission due to congestive heart failure during 12 week follow-up
Time frame: 12th week
Composite clinical endpoints
Composite clinical endpoints during 12 week follow-up, are defined as follows: 1. Composite of all-cause death and admission for heart failure 2. Composite of cardiac death and admission for heart failure
Time frame: 12th week
Safety endpoint
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.
Time frame: 12th week
This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Seoul National University Hospital