Clinical trial NCT01646515: Udenafil Therapy to Improve Symptomatology, Exercise Tolerance and Hemodynamics in Patients With Chronic Systolic Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Systolic Heart Failure
Keywords: systolic heart failure
udenafil
exercise capacity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Dong-A Pharmaceutical Co., Ltd.
First posted: 2012-07-20
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility 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)

Primary outcomes:
measure: VO2max with cardiopulmonary exercise test
timeFrame: Baseline and 12th weeks
Secondary outcomes:
measure: The changes of left ventricle ejection fraction
timeFrame: baseline and 12 th week
measure: serum BNP level
timeFrame: Baseline, 4th week, and 12th week
measure: Change of ventilator efficiency (VE/VCO2 slope) in cardiopulmonary exercise test
timeFrame: Baseline and 12th week
measure: Change of symptomatic status expressed as New York Heart Association (NYHA) functional class
timeFrame: Baseline, 4th week, and 12th week
measure: Change of pulmonary artery systolic pressure (PASP) in echocardiography at rest and during exercise
timeFrame: Baseline and 12th week
measure: Safety endpoint
timeFrame: 12th week
measure: Change of symptomatic status expressed as Borg dyspnea index
timeFrame: baseline, 4 weeks and 12 weeks
Other outcomes:
measure: All cause death, cardiac death, and heart failure-related admission and their composite
timeFrame: 12 week
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: 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.