Effects of Pycnogenol on Cardiac Fibrosis and Diastolic Dysfunction in Aged Hypertensive Subjects
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Cardiac Fibrosis, Diastolic Dysfunction
In brief
The purpose of this study is to determine whether Pycnogenol, a natural pine bark extract, is effective in modifying the age-dependent process of cardiac fibrosis and diastolic function in aged hypertensive subjects.
Key facts
- Study ID
- NCT00952627
- Run by
- University of Arizona
- People needed
- 9
- Starts
- 2009-07-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2013-12-17
Who can join
Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The subjects will consist of ambulatory males and females, 50-75 years of age, of any race, diagnosed with hypertension (diagnosis made over 6 months), and echocardiographic evidence of grade I or II diastolic dysfunction.
- There is no need for standardization of hypertension treatment, as we select only patients who have diastolic dysfunction during treatment.
You may not qualify if…
- Unstable angina or myocardial infarction in the past 3 months.
- Biochemical evidence of renal or hepatic failure.
- Severe anemia: defined as hemoglobin level less than 7 g/dL.
- Current cancer or other major illness not associated with the heart.
- Bleeding disorders.
- Taking anticoagulants including low dose aspirin.
- Diabetes.
- Known allergy to Pycnogenol.
- Being pregnant or breastfeeding.
- Systolic blood pressure over 180 mmHg or less than 100 mmHg, and Diastolic blood pressure over 110 mmHg or less than 50 mmHg.
- Current smoking.
- Having breast implants.
- Taking any of the following: birth control products, Diethylstilbestrol, Ephedra, ephedrine, or pseudoephedrine (except where used in prescription products), hormone replacement products, Isotretinoin, any product containing mercury, Phentermine in combination with fenfluramine (including but not limited to Pondimin) or dexfenfluramine (Redux).
Where it is running
- University of Arizona, Sarver Heart Center — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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