ULTIMATE-SHF trial (UdenafiL Therapy to Improve symptoMAtology, exercise Tolerance and hEmodynamics in patients with chronic systolic heart failure): study protocol ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2013-06-22

AUTHORS

Kyung-Hee Kim, Hyung-Kwan Kim, In-Chang Hwang, Seung-Pyo Lee, Hyun-Jai Cho, Hyun-Jae Kang, Yong-Jin Kim, Dae-Won Sohn

ABSTRACT

BACKGROUND: Over the last few years, the use of phosphodiesterase type 5 (PDE5) inhibitors has been expanded to management of various cardiovascular disorders beyond pulmonary arterial hypertension. This study is designed to investigate the ability of udenafil, a newly developed long-acting PDE5 inhibitor, to improve functional capacity and hemodynamic status in a cohort of chronic systolic heart failure (SHF) patients. METHODS/DESIGN: Stable, chronic SHF patients will be randomly assigned to placebo (26 patients) or udenafil at a dose of 50 mg twice per day (26 patients) for the first 4 weeks followed by 100 mg twice daily for the next 8 weeks. Eligibility criteria will be age ≥ 18 years, clinical diagnosis of chronic SHF with current New York Heart Association class II to IV symptoms, left ventricular ejection fraction ≤ 40%, and experience of at least one of following during the 12 months prior to study entry: hospitalization for decompensated heart failure, acute treatment with intravenous loop diuretics or hemofiltration, or pulmonary artery systolic pressure ≥ 40 mmHg on transthoracic echocardiography. Pharmacological therapy for SHF will be optimized in all patients at least 30 days before study entry. The primary outcome will be the change of maximal oxygen uptake, assessed by cardiopulmonary exercise testing. Secondary outcomes will include changes in ventilatory efficiency (minute ventilation/carbon dioxide production slope), left ventricular systolic and diastolic parameters, pulmonary artery systolic pressure, plasma concentration of brain natriuretic peptide, occurrence of mortality or hospitalization for heart failure, and the occurrence of any adverse event. CLINICAL TRIAL REGISTRATION: Unique identifier: NCT01646515. More... »

PAGES

188-188

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/1745-6215-14-188

DOI

http://dx.doi.org/10.1186/1745-6215-14-188

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1009023989

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/23799908


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108 outcomes
109 oxygen uptake
110 parameters
111 patients
112 peptides
113 pharmacological therapy
114 phosphodiesterase type 5 inhibitors
115 plasma concentrations
116 pressure
117 primary outcome
118 protocol
119 pulmonary arterial hypertension
120 pulmonary artery systolic pressure
121 status
122 study
123 study entry
124 symptoms
125 systolic
126 systolic heart failure patients
127 systolic pressure
128 testing
129 therapy
130 transthoracic echocardiography
131 treatment
132 trials
133 type 5 inhibitors
134 unique identifiers
135 uptake
136 use
137 ventilatory efficiency
138 ventricular ejection fraction
139 ventricular systolic
140 weeks
141 years
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