Pilot study for the treatment of heart failure with Pycnogenol
| ISRCTN | ISRCTN22412590 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22412590 |
| Secondary identifying numbers | HF2007AM |
- Submission date
- 06/08/2007
- Registration date
- 06/12/2007
- Last edited
- 06/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Akira Matsumori
Scientific
Scientific
Kyoto University Graduate School of Medicine
Department of Cardiovascular Medicine
54 Kawahara-cho Shogoin
Sakyo-ku
Kyoto
606 8507
Japan
Study information
| Study design | 12 week randomised, double-blind placebo-controlled matched pairs study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| 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(s) | Approved by the Ethics Committee at Okuizumo Hospital in Shimane prefecture, Japan, on 24 May 2007 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Pycnogenol |
| Primary outcome measure | 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 study start date | 10/08/2007 |
| Overall study end date | 31/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| 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 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
Study participating centre
Kyoto University Graduate School of Medicine
Kyoto
606 8507
Japan
606 8507
Japan
Sponsor information
Kyoto University (Japan)
University/education
University/education
c/o Dr Akira Matsumori
Kyoto University Graduate School of Medicine
Department of Cardiovascular Medicine
54 Kawahara-cho Shogoin
Sakyo-ku
Kyoto
6068507
Japan
| Website | http://www.kyoto-u.ac.jp/index-e.html |
|---|---|
"ROR" |
https://ror.org/02kpeqv85 |
Funders
Funder type
University/education
Kyoto University, Cardiomyopathy and Myocarditis Research Fund (Japan)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
