Pilot study for the treatment of heart failure with Pycnogenol

Completed

Conditions: Heart failure
Circulatory System

Registration Number: ISRCTN22412590

Lead Sponsor: Kyoto University (Japan)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

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
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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients undergo tests for maximal workload and pressure-heart product at 0, 4, 8, and 12 weeks after enrollment. <br><br>Maximal workload: As determined by a symptom-limited bicycle exercise test in the seated position. <br>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 Outcome Measures

Name	Time	Method
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: <br>1. Early fatigability<br>2. Dyspnea<br>3. General capability<br>4. Lassitude<br>5. Feeling depressed<br>6. Anxiety<br> <br>Scores range from 0 = not present, 1 = occasionally mild, 2 = frequently mild, 3 = moderate, 4 = severe.<br>Blood analysis: Routine clinical chemistry in addition to the assays of BNP (NT-proBNP), C-Reactive Protein and troponin T.