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Trial · NCT01646515

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

NCT01646515, Phase 3, Terminated, Seoul National University Hospital

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Udenafil Therapy to Improve Symptomatology, Exercise Tolerance and Hemodynamics in Patients With Chronic Systolic Heart Failure. Trials, record NCT01646515. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01646515

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Udenafil Therapy to Improve Symptomatology, Exercise Tolerance and Hemodynamics in Patients With Chronic Systolic Heart Failure
NCT number
NCT01646515
Status
Terminated
Phases
Phase 3
Enrollment
41 participants, actual
Lead sponsor
Seoul National University Hospital
Conditions
Systolic Heart Failure
Interventions
Placebo, Udenafil (Zydena)
First posted
2012-07-20
Last updated
2014-04-24

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryVO2max with cardiopulmonary exercise testBaseline and 12th weeksVO2 max was defined as cardiopulmonary exercise capacity Comparison between groups and within groups
SecondaryThe changes of left ventricle ejection fractionbaseline and 12 th weekcomparison between groups and within groups
Secondaryserum BNP levelBaseline, 4th week, and 12th weekComparison between groups and within groups
SecondaryChange of ventilator efficiency (VE/VCO2 slope) in cardiopulmonary exercise testBaseline and 12th weekComparison between groups and within groups
SecondaryChange of symptomatic status expressed as New York Heart Association (NYHA) functional classBaseline, 4th week, and 12th weekComparison between groups and within groups
SecondaryChange of pulmonary artery systolic pressure (PASP) in echocardiography at rest and during exerciseBaseline and 12th weekComparison between groups and within groups.
SecondarySafety endpoint12th 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.
SecondaryChange of symptomatic status expressed as Borg dyspnea indexbaseline, 4 weeks and 12 weeksComparison between groups and within groups.
OtherAll cause death, cardiac death, and heart failure-related admission and their composite12 weekAll cause death, cardiac death, and heart failure-related admission and their composite

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
23799908DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01646515

GET https://conductscience.org/api/trials/v1/NCT01646515/registered