Effects of Pycnogenol on Cardiac Fibrosis and Diastolic Dysfunction in Aged Hypertensive Subjects

NCT00952627 | Terminated Phase 2

• 1 other identifier: UofAFRS 439130
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 hypertensive subjects.

Conditions

Cardiac Fibrosis; Diastolic Dysfunction

Keywords

Cardiac fibrosis; Diastolic dysfunction; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• liver and kidney function tests

  at baseline and at 4 months

• Immunological measurements including the cytokine profile in serum (interleukin (IL)-4, IL-10, interferon-gamma, C-reactive protein).

  baseline and at 4 months

Study Arms (2)

Pycnogenol

EXPERIMENTAL

200 mg/day

Dietary Supplement: Pycnogenol

Control

PLACEBO COMPARATOR

placebo

Dietary Supplement: Placebo

Interventions

Pycnogenol DIETARY_SUPPLEMENT

50 mg tablet, 200 mg/day, 4 tablets/day

Pycnogenol

Placebo DIETARY_SUPPLEMENT

Control

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of Arizona: lead
• Horphag Research: collaborator

Study Sites (1)

University of Arizona, Sarver Heart Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

pycnogenols

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ronald R Watson, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 6, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

US (1)