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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.T

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.

Authors+Show Affiliations

Department of Internal Medicine, Seoul National University College of Medicine, Seoul 110-744, Korea.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23799908

Citation

Kim, Kyung-Hee, et al. "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, vol. 14, 2013, p. 188.
Kim KH, Kim HK, Hwang IC, et al. 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;14:188.
Kim, K. H., Kim, H. K., Hwang, I. C., Lee, S. P., Cho, H. J., Kang, H. J., Kim, Y. J., & Sohn, D. W. (2013). 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, 14, 188. https://doi.org/10.1186/1745-6215-14-188
Kim KH, et al. 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. PubMed PMID: 23799908.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Kim,Kyung-Hee, AU - Kim,Hyung-Kwan, AU - Hwang,In-Chang, AU - Lee,Seung-Pyo, AU - Cho,Hyun-Jai, AU - Kang,Hyun-Jae, AU - Kim,Yong-Jin, AU - Sohn,Dae-Won, Y1 - 2013/06/22/ PY - 2013/03/24/received PY - 2013/06/06/accepted PY - 2013/6/27/entrez PY - 2013/6/27/pubmed PY - 2013/10/18/medline SP - 188 EP - 188 JF - Trials JO - Trials VL - 14 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/23799908/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_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-188 DB - PRIME DP - Unbound Medicine ER -