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Completed

NCT Number: NCT01185067

Physiological Effects of Grape Seed Extract in Diastolic Heart Failure

Diastolic heart failure (also known as "heart failure with normal ejection fraction" or "heart failure with preserved ejection fraction") occurs even though the heart muscle's pumping function is normal. In many cases diastolic heart failure is related to stiffening of the heart and blood vessels in people who have high blood pressure. Current guidelines suggest that patients should limit the salt content of their diet, as too much salty food can cause fluid retention and other problems in diastolic heart failure. Studies in animals with diastolic heart failure suggest that antioxidant chemicals found in grapes can block some of the harmful effects of salty diets. Because it is often difficult for patients with diastolic heart failure to maintain a low salt diet, the investigators are researching the effects of the antioxidant properties of grape seed extract, a natural supplement made from grape seeds. The investigators hypothesize that supplementing the diet with grape seed extract (GSE) can decrease the levels of harmful chemicals and improve heart and blood vessel function in patients with diastolic heart failure and a history of high blood pressure.

The University of Michigan research group plans to enroll 25 patients with a history of high blood pressure and diastolic heart failure in a research study. The study will assess the effects of GSE on hormones and other chemicals that can cause heart and blood vessel damage. The investigators will also study the effects of GSE on the ability of the blood vessels and heart muscles to relax at the proper time and speed. Finally, the investigators will observe how GSE affects participants' overall ability to exercise, quality of life, and blood pressure control. Study participants will be randomly assigned to take either GSE or placebo (looks like but does not contain GSE) capsules twice a day for six weeks. After a two-week break, all subjects will cross over to the opposite group of capsules for an additional six-week period. At the start of the study and at the end of each six-week time period study participants will have non-invasive heart and blood vessel testing, blood work and urine tests, and blood pressure monitoring.

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Key information

Conditions

Diastolic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure With Preserved Ejection Fraction Heart Failure, Diastolic Hypertension Hypertensive Heart Disease Oxidative Stress Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion:

  • Signs and symptoms of heart failure
  • Left ventricular ejection fraction ≥ 50% (contrast ventriculography, echocardiography, nuclear scintigraphy, MRI or CT imaging)
  • Diastolic dysfunction on previous echocardiogram/catheterization, or indeterminate diastolic function with supporting evidence of heart failure (HF) (as per European Society of Cardiology guidelines)
  • History of systemic hypertension
  • Age ≥ 50 years
  • Willing to adhere to prescribed course of supplementation
  • Informed consent

Exclusion criteria

  • Daily intake of antioxidant supplements or vitamins beyond that provided in a standard daily multivitamin (e.g. high-dose vitamin E or vitamin C)
  • NYHA Class IV heart failure symptoms (except during previous hospitalization)
  • Hospitalization for decompensated heart failure within past one month
  • Severely uncontrolled hypertension (SBP ≥ 180 and.or DBP ≥ 100 at rest, on current antihypertensive regimen
  • Uncontrolled diabetes mellitus (hemoglobin A1C > 9%)
  • Severe renal (estimated GFR < 30 ml/min) or hepatic disease/failure
  • Severe anemia (Hgb < 9)
  • Primary exercise limitation due to severe pulmonary disease
  • Unacceptably poor echocardiographic images for analysis
  • Worse than moderate mitral or aortic stenosis or insufficiency.
  • Non-hypertensive cause of HFpEF (e.g. valvular disease, congenital heart disease, amyloidosis, sarcoidosis, constrictive pericardial syndromes)
  • Myocardial infarction or unstable angina, including new or worsening anginal syndrome, within the past three months
  • Uncontrolled arrhythmia (including non rate-controlled atrial fibrillation)
  • Terminal illness expected to result in death within six months or active solid-organ cancer
  • Psychiatric disorder (or dementia) with potential to compromise adherence
  • Changes in medical regimen for heart disease or hypertension within past 1 month (except diuretic dose adjustment)

Treatment and study plan

grape seed extract (MegaNatural BP, Polyphenolics, Inc.)

Drug

Subjects will be randomized in double-blind fashion to either grape seed extract (GSE) or maltodextrin placebo capsules for for 6 weeks. Patient will take 300 mg GSE/placebo twice a day for 6 weeks. Patient will have a 2 week washout period and then cross over to the opposite group for an additional 6 weeks.

Other names: grapes, wine, polyphenols, resveratrol, quercetin, anthocyanins, flavonoids, flavanols, flavonols, antioxidants

Primary outcomes

  1. Brachial artery flow-mediated dilation (FMD)

    Time frame: Pre-six weeks of investigational drug and placebo intervention

    Ultrasound measure of conduit artery endothelial function

  2. Brachial artery flow-mediated dilation (FMD)

    Time frame: Post-six weeks of investigational drug and placebo intervention

    Ultrasound measure of conduit artery endothelial function

Secondary outcomes

  1. 24-hour blood pressure

    Time frame: Pre-six weeks of investigational drug and placebo intervention

    Mean and diurnal variation

  2. EndoPAT arterial endothelial function

    Time frame: Pre-six weeks of investigational drug and placebo intervention

    Plethysmographic measure of resistance arterial endothelial function

  3. Carotid-femoral pulse wave velocity

    Time frame: Pre-six weeks of investigational drug and placebo intervention

  4. Maximal exercise capacity and oxygen consumption

    Time frame: Pre-six weeks of investigational drug and placebo intervention

  5. Resting and post-exercise ventricular systolic and diastolic function

    Time frame: Pre-six weeks of investigational drug and placebo intervention

    Standard and novel echocardiographic measures including strain/strain rate

  6. Urinary 8-isoprostanes

    Time frame: Pre-six weeks of investigational drug and placebo intervention

    Measure of oxidative stress

  7. Heart failure related quality of life

    Time frame: Pre-six weeks of investigational drug and placebo intervention

    Minnesota Living With Heart Failure Questionnaire

  8. 24-hour blood pressure

    Time frame: Post-six weeks of investigational drug and placebo intervention

    Mean and diurnal variation

  9. EndoPAT arterial endothelial function

    Time frame: Post-six weeks of investigational drug and placebo intervention

    Plethysmographic measure of resistance arterial endothelial function

  10. Carotid-femoral pulse wave velocity

    Time frame: Post-six weeks of investigational drug and placebo intervention

  11. Maximal exercise capacity and oxygen consumption

    Time frame: Post-six weeks of investigational drug and placebo intervention

  12. Resting and post-exercise ventricular systolic and diastolic function

    Time frame: Post-six weeks of investigational drug and placebo intervention

    Standard and novel echocardiographic measures including strain/strain rate

  13. Urinary 8-isoprostanes

    Time frame: Post-six weeks of investigational drug and placebo intervention

    Measure of oxidative stress

  14. Heart failure related quality of life

    Time frame: Post-six weeks of investigational drug and placebo intervention

    Minnesota Living With Heart Failure Questionnaire

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

GRAPe Seed Extract and Ventriculovascular Investigation in Normal Ejection-Fraction Heart Failure

Acronym: GRAPEVINE-HF

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Aug 19, 2010
Registry last updated
Jun 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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