The investigators hypothesized that udenafil, a newly developed phosphodiesterase type 5
inhibitor, would improve symptom, exercise capacity and hemodynamic status in patients with
heart failure with preserved ejection fraction (HFpEF).
Drug: Udenafil (Zydena)
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Full eligibility criteria for NCT01599117
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Previous clinical diagnosis of heart failure with preserved ejection fraction (or diastolic heart failure) with current New York Heart association (NYHA) class II-IV symptoms
Left ventricular ejection fraction (LVEF) greater than or equal to 50%, as determined by echocardiography in the 12 months before study entry
Has experienced at least one of the following in the 12 months before study entry
Hospitalization for decompensated heart failure
Acute treatment with intravenous loop diuretics or hemofiltration
E/E' ratio greater than or equal to 15 measured by echocardiography
E/E' ratio greater than or equal to 8, and left atrial volume index (LAVI) greater than or equal to 40 ml/m2 measured by echocardiography
E/E' ratio greater than or equal to 8 measured by echocardiography, and plasma BNP concentration greater or equal to 200 pg/ml
History of reduced LVEF (less than 50%)
Valve disease (greater than mild stenosis or regurgitation)
Infiltrative or inflammatory myocardial disease
Obstructive or restrictive lung disease
Primary pulmonary arteriopathy
Has neuromuscular, orthopedic, or other non-cardiac condition that prevents individual from exercise testing
Has experienced myocardial infarction or unstable angina, or has undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 60 days before study entry
Non-cardiac illness with estimated life expectancy less than 1 year at the time of study entry, based on the judgment of the physician
Current use of nitrate therapy
Current use of other phosphodiesterase 5 inhibitors (ie. sildenafil, vardenafil, tadalafil) for treatment of impotence or pulmonary artery hypertension
Current use of cytochrome P450 3A4 inhibitors (ie. ketoconazole, itraconazole, erythromycin, saquinavir, cimetidine, protease inhibitors for HIV)
Severe hypotension (systolic blood pressure [SBP] less than 90mmHg or diastolic blood pressure [DBP] less than 50mmHg) or uncontrolled hypertension (SBP greater than 180mmHg or DBP greater than 100mmHg)
Resting heart rate (HR) greater than 100bpm
Known severe renal dysfunction (estimated glomerular filtration rate [GFR] less than 30ml/min/1.73m2 by modified modification of diet in renal disease [MDRD] equation)
Known severe liver disease (alanine transaminase [ALT] or aspartate aminotransferase
[AST] level greater than three times the upper normal limit, alkaline phosphatase
[ALP] or total bilirubin greater than two times the upper normal limit)
History of leukemia, multiple myeloma or penile deformities that increase the risk for priapism (eg. Peyronie's disease)
History of proliferative diabetic retinopathy, retinitis pigmentosa, nonischemic optic neuropathy, or unexplained visual disturbance
Female patients currently pregnant or women of childbearing age who were not using contraception
Tris trial is registered with FDA with number: NCT01599117. The sponsor of the trial is Seoul National University Hospital and it is looking for 52 volunteers for the current phase.
Official trial title: Udenafil Therapy to Improve Symptomatology, Exercise Tolerance and Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction: Phase III, Randomized, Double-blind, Placebo-controlled Trial [ULTIMATE-HFpEF Trial]
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