ISRCTN22412590
Completed
Not Applicable
Pilot study for the treatment of heart failure with Pycnogenol
Kyoto University (Japan)0 sites30 target enrollmentDecember 6, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart failure
- Sponsor
- Kyoto University (Japan)
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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