NCT01646515

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

2.1 years

First QC Date

June 13, 2012

Last Update Submit

April 22, 2014

Conditions

Systolic Heart Failure

Keywords

systolic heart failureudenafilexercise capacity

Outcome Measures

Primary Outcomes (1)

  • VO2max with cardiopulmonary exercise test

    VO2 max was defined as cardiopulmonary exercise capacity Comparison between groups and within groups

    Baseline and 12th weeks

Secondary Outcomes (7)

  • The changes of left ventricle ejection fraction

    baseline and 12 th week

  • serum BNP level

    Baseline, 4th week, and 12th week

  • Change of ventilator efficiency (VE/VCO2 slope) in cardiopulmonary exercise test

    Baseline and 12th week

  • Change of symptomatic status expressed as New York Heart Association (NYHA) functional class

    Baseline, 4th week, and 12th week

  • Change of pulmonary artery systolic pressure (PASP) in echocardiography at rest and during exercise

    Baseline and 12th week

  • +2 more secondary outcomes

Other Outcomes (1)

  • All cause death, cardiac death, and heart failure-related admission and their composite

    12 week

Study Arms (2)

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.

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.

Drug: Udenafil (Zydena)

Interventions

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

placebo arm
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.

Udenafil

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age, LV EF \< 40%

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 23799908DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic

Interventions

udenafil

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 13, 2012

First Posted

July 20, 2012

Study Start

December 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations

KR(1)