A Randomized Trial of Udenafil Therapy in Patients With Heart Failure With Preserved Ejection Fraction [ULTIMATE-HFpEF]

• Status: Unknown status
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Dong-A Pharmaceutical Co., Ltd.; Seoul National University Bundang Hospital
• Treatments: Udenafil

Criteria

Inclusion Criteria:

• 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

1. Hospitalization for decompensated heart failure

2. Acute treatment with intravenous loop diuretics or hemofiltration

3. E/E' ratio greater than or equal to 15 measured by echocardiography

4. 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

5. E/E' ratio greater than or equal to 8 measured by echocardiography, and plasma BNP concentration greater or equal to 200 pg/ml

Exclusion Criteria:

• History of reduced LVEF (less than 50%)

• Valve disease (greater than mild stenosis or regurgitation)

• Hypertrophic cardiomyopathy

• Infiltrative or inflammatory myocardial disease

• Pericardial 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

• Listed for heart transplantation