Status:
TERMINATED
Effects of Pycnogenol on Cardiac Fibrosis and Diastolic Dysfunction in Aged Hypertensive Subjects
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
Horphag Research
Conditions:
Cardiac Fibrosis
Diastolic Dysfunction
Eligibility:
All Genders
50-75 years
Phase:
PHASE2
Brief Summary
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 hypert...
Detailed Description
Diastolic heart failure without left ventricular systolic dysfunction comprises 30% to 50% of heart failure in clinical practice, and hypertensive heart disease is a major cause of this type of heart ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00952627
Start Date
July 1 2009
End Date
July 1 2011
Last Update
December 17 2013
Active Locations (1)
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1
University of Arizona, Sarver Heart Center
Tucson, Arizona, United States, 85724