Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00952627
Other study ID # UofAFRS 439130
Secondary ID
Status Terminated
Phase Phase 2
First received August 3, 2009
Last updated December 14, 2013
Start date July 2009
Est. completion date July 2011

Study information

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

Clinical Trial 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.


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 failure. The complication of myocardial fibrosis should be avoided in hypertensive heart disease, because increasing ventricular stiffness caused by myocardial fibrosis leads to the development of diastolic dysfunction of the heart. Diastolic dysfunction in patients with prolonged hypertension is often associated with myocardial fibrosis in addition to muscular hypertrophy as a final feature of hypertensive heart disease. The high risk of developing maladaptive cardiac remodeling during hypertension, and failure of pharmacological treatments to limit or even reverse this progressive stiffening of the myocardium, has led to the study of effects of Pycnogenol, a bioflavonoid-rich pine bark extract, with pleiotropic actions on cardiovascular system. Pycnogenol prevents adverse hypertension-induced myocardial remodeling in mice, through modulation of gene expression and activity of enzyme matrix metalloproteinases and their tissue inhibitors, affecting myocardial collagen degradation rate. Despite the mounting evidence suggesting the anti-remodeling effect of Pycnogenol in animal models, the clinical efficacy of Pycnogenol in hypertension-induced diastolic dysfunction is unreported. This leads to our central hypothesis that Pycnogenol reverses the hypertension-induced cardiac fibrosis and diastolic dysfunction in hypertensive patients. Therefore in this clinical investigation, we will investigate the effects of Pycnogenol in modifying hypertension-induced cardiac fibrosis (by measuring the serum markers of myocardial fibrosis and collagen turnover) and diastolic dysfunction (by transthoracic echocardiogram). We expect to improve diastolic function and ameliorate myocardial fibrosis with the nutritional supplement Pycnogenol, by modulation of MMPs and TIMPs enzyme activities.


Recruitment information / eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Pycnogenol
50 mg tablet, 200 mg/day, 4 tablets/day
Placebo


Locations

Country Name City State
United States University of Arizona, Sarver Heart Center Tucson Arizona

Sponsors (2)

Lead Sponsor Collaborator
University of Arizona Horphag Research

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT04558450 - Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN) N/A
Recruiting NCT02499601 - CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD) N/A
Completed NCT01775865 - Targeting Inflammation to Treat Cardiovascular Aging Phase 2
Terminated NCT01188369 - Effects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy Phase 4
Recruiting NCT05552521 - Diastolic Dysfunction in Septic Shock and Cardiomyopathy Genetic Variants
Recruiting NCT05438030 - Diastolic Function Assessment With Cardiac Magnetic Resonance Imaging N/A
Completed NCT04128735 - Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery
Completed NCT00689819 - Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients N/A
Recruiting NCT04149990 - Angiotensin-Neprilysin Inhibition in Diastolic Dysfunction After AMI Phase 2
Completed NCT03768752 - Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients
Completed NCT02932436 - Effects of Empagliflozin on Left Ventricular Diastolic Function Compared to Usual Care in Type 2 Diabetics Phase 4
Recruiting NCT05847244 - The Effect of Addition of Metformin In Obese Non- Diabetic Patients With Heart Failure With Preserved Ejection Fraction Phase 2
Enrolling by invitation NCT04190420 - The Transition From Hypertension to Hypertensive Heart Disease and Heart Failure, the PREFERS Hypertension Study
Completed NCT04114474 - Pre-operative Focused Transthoracic Echocardiography for Prediction of Post-operative Cardiac Complications
Not yet recruiting NCT06131008 - Diastology-Guided Management of Decompensated Heart Failure N/A
Completed NCT03110614 - Diastolic Dysfunction and Pauci-inflammatory Acute Exacerbations of COPD
Not yet recruiting NCT02285309 - Perioperative Measurements of Diastolic Function in Cardiac Surgery N/A
Completed NCT01761318 - Effect of Liraglutide on Cardiovascular Endpoints in Diabetes Mellitus Type 2 Patients Phase 4
Completed NCT00907439 - Study of the Effect of Inhaled Anesthetics on Diastolic Heart Function Using a Doppler-derived Efficiency Index N/A
Completed NCT00804518 - Effect of Exercise on Heart Function in Healthy Elderly People N/A