Condition category
Circulatory System
Date applied
06/08/2007
Date assigned
06/12/2007
Last edited
06/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Akira Matsumori

ORCID ID

Contact details

Kyoto University Graduate School of Medicine
Department of Cardiovascular Medicine
54 Kawahara-cho Shogoin
Sakyo-ku
Kyoto
606 8507
Japan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HF2007AM

Study information

Scientific title

Acronym

Study hypothesis

Pycnogenol, standardized French maritime pine bark extract, has shown beneficial effects on various cardiovascular health parameters such as blood pressure and cholesterol levels in both preclinical as well as clinical trials. The aim of this study is to investigate the effect of 200 mg daily of Pycnogenol on objective and subjective symptoms in patients with heart failure New York Heart Association (NYHA) status II.

Ethics approval

Approved by the Ethics Committee at Okuizumo Hospital in Shimane prefecture, Japan, on 24 May 2007

Study design

12 week randomised, double-blind placebo-controlled matched pairs study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Heart failure

Intervention

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. Drug intake will be controlled and any unwanted effect reported at each visit.

Intervention type

Drug

Phase

Not Specified

Drug names

Pycnogenol

Primary outcome measures

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 outcome measures

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.

Overall trial start date

10/08/2007

Overall trial end date

31/07/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

10/08/2007

Recruitment end date

31/07/2008

Locations

Countries of recruitment

Japan

Trial participating centre

Kyoto University Graduate School of Medicine
Kyoto
606 8507
Japan

Sponsor information

Organisation

Kyoto University (Japan)

Sponsor details

c/o Dr Akira Matsumori
Kyoto University Graduate School of Medicine
Department of Cardiovascular Medicine
54 Kawahara-cho Shogoin
Sakyo-ku
Kyoto
6068507
Japan

Sponsor type

University/education

Website

http://www.kyoto-u.ac.jp/index-e.html

Funders

Funder type

University/education

Funder name

Kyoto University, Cardiomyopathy and Myocarditis Research Fund (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes