Udenafil Therapy to Improve Symptomatology, Exercise Tolerance and Hemodynamics in Patients With Chronic Systolic Heart Failure

Phase 3

Terminated

• Conditions: Systolic Heart Failure
• Interventions: Drug: Placebo; Drug: Udenafil (Zydena)

• Registration Number: NCT01646515
• Lead Sponsor: Seoul National University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-20
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-22
• Last Update Posted: 2014-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• ≥ 18 years of age, LV EF < 40%

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo arm	Placebo	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	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
serum BNP level	Baseline, 4th week, and 12th week	Comparison between groups and within groups
The changes of left ventricle ejection fraction	baseline and 12 th 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: 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.
Change of symptomatic status expressed as Borg dyspnea index	baseline, 4 weeks and 12 weeks	Comparison between groups and within groups.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of