Heart failure Circulatory System Heart failure
Conditions
Interventions
200 mg Pycnogenol (standardized extract of French maritime pine bark) or placebo for 12 weeks. Patients receiving diuretics before enrollment should continue usage and not change dose/intake intervals
Sponsors
Kyoto University (Japan)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients over 40 years of age with chronic congestive heart failure (NYHA class II), known for at least 6 months which were previously untreated or treated with a diuretic and/or a low dose of an ACE inhibitor. Patients must have an exercise capacity of at least 75 watts as assessed by seated bicycle ergometry.
Exclusion criteria
Exclusion criteria: 1. NYHA status I, III or IV 2. Treatment with digitalis within the previous 6 months 3. Exercise capacity of >75 W for 2 min at the test during run-in 4. Unstable angina or myocardial infarction within the last 6 months 5. Atrial fibrillation or ventricular arrhythmia greater than or equal to Lown III 6. Cardiac valvular disease or hypertrophic cardiomyopathy 7. Significant hypertension or hypotension ( 175 mmHg systolic) 8. Electrolyte disturbances, hyperuricemia, hypovolemia 9. Impaired renal function (creatinine >1.8 mg/dL) or hepatic function 10. Obstructive airways disease 11. Insulin-dependent diabetes 12. Malignant or other serious disease 13. Hypersensitivity to study drug 14. Pregnancy, unreliable contraception, breast-feeding mothers 15. Participation in another clinical trial within the last 6 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients undergo tests for maximal workload and pressure-heart product at 0, 4, 8, and 12 weeks after enrollment. Maximal workload: As determined by a symptom-limited bicycle exercise test in the seated position. Pressure-heart rate product: Immediately after 2 min work at 50 W, systolic blood pressure and heart rate are recorded. Pressure-heart rate product is calculated by units of systolic blood pressure (mmHg) x heart rate per minute divided by 100. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patients will report scores for dyspnea and fatigue for the foregoing 4 weeks upon enrollment (baseline) and repeat evaluation at 4, 8, and 12 weeks after enrollment. Symptom scores will be evaluated by asking patients about the severity of the following symptoms: 1. Early fatigability 2. Dyspnea 3. General capability 4. Lassitude 5. Feeling depressed 6. Anxiety Scores range from 0 = not present, 1 = occasionally mild, 2 = frequently mild, 3 = moderate, 4 = severe. Blood analysis: Routine clinical chemistry in addition to the assays of BNP (NT-proBNP), C-Reactive Protein and troponin T. | — |
Countries
Japan
Outcome results
None listed