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

Systolic Heart Failure Clinical Trial

— ULTIMATE-SHF  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01646515
• Other study ID #: H-1102-063-352
• Status: Terminated
• Phase: Phase 3
• First received: June 13, 2012
• Last updated: April 22, 2014
• Start date: December 2011
• Est. completion date: January 2014

Study information

• Verified date: April 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if udenafil improves exercise tolerance in patients with systolic heart failure.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Systolic Heart Failure

Intervention

Drug:
• Placebo
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)
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Dong-A Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	VO2max with cardiopulmonary exercise test	VO2 max was defined as cardiopulmonary exercise capacity; Comparison between groups and within groups	Baseline and 12th weeks
Secondary	The changes of left ventricle ejection fraction	comparison between groups and within groups	baseline and 12 th week
Secondary	serum BNP level	Comparison between groups and within groups	Baseline, 4th week, and 12th week
Secondary	Change of ventilator efficiency (VE/VCO2 slope) in cardiopulmonary exercise test	Comparison between groups and within groups	Baseline and 12th week
Secondary	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
Secondary	Change of pulmonary artery systolic pressure (PASP) in echocardiography at rest and during exercise	Comparison between groups and within groups.	Baseline and 12th week
Secondary	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.	12th week
Secondary	Change of symptomatic status expressed as Borg dyspnea index	Comparison between groups and within groups.	baseline, 4 weeks and 12 weeks