Pilot study for the treatment of heart failure with Pycnogenol

Kyoto University (Japan)0 个研究点目标入组 30 人开始时间: 2007年12月6日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•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.

•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 (< 60 mmHg or greater than or equal to 105 mmHg diastolic or < 90 mmgH or > 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

发起方

Kyoto University (Japan)