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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
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.
University of Michigan
Ann Arbor, Michigan, United States
Brachial artery flow-mediated dilation (FMD)
Ultrasound measure of conduit artery endothelial function
Time frame: Pre-six weeks of investigational drug and placebo intervention
Brachial artery flow-mediated dilation (FMD)
Ultrasound measure of conduit artery endothelial function
Time frame: Post-six weeks of investigational drug and placebo intervention
24-hour blood pressure
Mean and diurnal variation
Time frame: Pre-six weeks of investigational drug and placebo intervention
EndoPAT arterial endothelial function
Plethysmographic measure of resistance arterial endothelial function
Time frame: Pre-six weeks of investigational drug and placebo intervention
Carotid-femoral pulse wave velocity
Time frame: Pre-six weeks of investigational drug and placebo intervention
Maximal exercise capacity and oxygen consumption
Time frame: Pre-six weeks of investigational drug and placebo intervention
Resting and post-exercise ventricular systolic and diastolic function
Standard and novel echocardiographic measures including strain/strain rate
Time frame: Pre-six weeks of investigational drug and placebo intervention
Urinary 8-isoprostanes
Measure of oxidative stress
Time frame: Pre-six weeks of investigational drug and placebo intervention
Heart failure related quality of life
Minnesota Living With Heart Failure Questionnaire
Time frame: Pre-six weeks of investigational drug and placebo intervention
24-hour blood pressure
Mean and diurnal variation
Time frame: Post-six weeks of investigational drug and placebo intervention
EndoPAT arterial endothelial function
Plethysmographic measure of resistance arterial endothelial function
Time frame: Post-six weeks of investigational drug and placebo intervention
Carotid-femoral pulse wave velocity
Time frame: Post-six weeks of investigational drug and placebo intervention
Maximal exercise capacity and oxygen consumption
Time frame: Post-six weeks of investigational drug and placebo intervention
Resting and post-exercise ventricular systolic and diastolic function
Standard and novel echocardiographic measures including strain/strain rate
Time frame: Post-six weeks of investigational drug and placebo intervention
Urinary 8-isoprostanes
Measure of oxidative stress
Time frame: Post-six weeks of investigational drug and placebo intervention
Heart failure related quality of life
Minnesota Living With Heart Failure Questionnaire
Time frame: Post-six weeks of investigational drug and placebo intervention
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