Diastolic Dysfunction Clinical Trial
Official title:
Mechanism of the Anti-remodeling Activity of the Over-the-counter Dietary Supplement, Pycnogenol, on Age-dependent Process of Cardiac Fibrosis in Aged Hypertensive Subjects With Echocardiographic Evidence of Grade I/II Diastolic Dysfunction
Verified date | December 2013 |
Source | University of Arizona |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 9 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Arizona, Sarver Heart Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona | Horphag Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cardiac fibrosis (by measuring the serum markers of myocardial fibrosis and collagen turnover) and diastolic dysfunction (by transthoracic echocardiogram) | at baseline and at 4 months | No | |
Secondary | liver and kidney function tests | at baseline and at 4 months | Yes | |
Secondary | Immunological measurements including the cytokine profile in serum (interleukin (IL)-4, IL-10, interferon-gamma, C-reactive protein). | baseline and at 4 months | No |
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