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Table 1 Eligibility criteria

From: 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

Inclusion criteria Exclusion criteria
1. Able to provide written informed consent 1. FEV1 <80% of predicted value or FEV1/FVC <70% on spirometry at screening
2. Men and women ≥18 years old 2. Other valve diseases greater than mild stenosis and/or regurgitation
3. Established clinical diagnosis of chronic systolic heart failure with NYHA class II to IV symptoms currently 3. Neuromuscular, orthopedic, or other noncardiac conditions that prevent completion of a maximal exercise testing
4. Left ventricular ejection fraction ≤40%, as determined by echocardiography at the baseline echocardiographic examination 4. Infiltrative/ inflammatory myocardial or pericardial disease
5. Primary pulmonary arteriopathy
5. Have experienced at least one of the following criteria in the 12 months before study entry: 6. Current use of nitrate preparation therapy (will be deleted) or other PDE5 inhibitors (that is, sildenafil, vardenafil, tadalafil) or cytochrome P450 3A4 inhibitors (ketoconazole, itraconazole, erythromycin)
- Hospitalization for decompensated heart failure  
- Acute treatment with intravenous loop diuretics or hemofiltration 7. Severe hypotension (SBP <90 mmHg or DBP <50 mmHg) or uncontrolled hypertension (SBP >180 mmHg or DBP >100 mmHg)
- Pulmonary artery systolic pressure ≥40 mmHg by echocardiography 8. Noncardiac illness with estimated life expectancy <1 year at the time of study entry, based on the judgment of the attending physician
6. Stable medical therapy for 1 month before study entry – no addition or removal or change in major class of medication dosage; that is, renin–angiotensin–aldosterone inhibitors, β-blockers 9. Known severe renal dysfunction (GFR <30 ml/minute/1.73 m2 by MDRD equation)
10. Known severe liver disease (ALT or AST level >3 times the upper normal limit, alkaline phosphatase or total bilirubin >2 times the upper normal limit)
11. Actively involved in any physical training program for at least 6 months before study entry
  12. Listed for heart transplantation
  1. ALT, alanine aminotransferase; AST, aspartate aminotransferase; DBP, diastolic blood pressure; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; GFR, glomerular filtration rate; MDRD, Modification of Diet in Renal Disease; NYHA, New York Heart Association; SBP, systolic blood pressure.