Table 1.
Eligibility criteria
| 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 |
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.