Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT01185067
Status:
COMPLETED
Last Update Posted:
2017-06-06
First Post:
2010-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physiological Effects of Grape Seed Extract in Diastolic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054144', 'term': 'Heart Failure, Diastolic'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056604', 'term': 'Grape Seed Extract'}, {'id': 'C000605877', 'term': 'grp protein, Drosophila'}, {'id': 'D014920', 'term': 'Wine'}, {'id': 'D059808', 'term': 'Polyphenols'}, {'id': 'D000077185', 'term': 'Resveratrol'}, {'id': 'D011794', 'term': 'Quercetin'}, {'id': 'D000872', 'term': 'Anthocyanins'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D044948', 'term': 'Flavonols'}, {'id': 'D000975', 'term': 'Antioxidants'}], 'ancestors': [{'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000434', 'term': 'Alcoholic Beverages'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000088082', 'term': 'Fermented Beverages'}, {'id': 'D000074421', 'term': 'Fermented Foods'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000081225', 'term': 'Stilbestrols'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020011', 'term': 'Protective Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2014-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-02', 'studyFirstSubmitDate': '2010-08-02', 'studyFirstSubmitQcDate': '2010-08-18', 'lastUpdatePostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brachial artery flow-mediated dilation (FMD)', 'timeFrame': 'Pre-six weeks of investigational drug and placebo intervention', 'description': 'Ultrasound measure of conduit artery endothelial function'}, {'measure': 'Brachial artery flow-mediated dilation (FMD)', 'timeFrame': 'Post-six weeks of investigational drug and placebo intervention', 'description': 'Ultrasound measure of conduit artery endothelial function'}], 'secondaryOutcomes': [{'measure': '24-hour blood pressure', 'timeFrame': 'Pre-six weeks of investigational drug and placebo intervention', 'description': 'Mean and diurnal variation'}, {'measure': 'EndoPAT arterial endothelial function', 'timeFrame': 'Pre-six weeks of investigational drug and placebo intervention', 'description': 'Plethysmographic measure of resistance arterial endothelial function'}, {'measure': 'Carotid-femoral pulse wave velocity', 'timeFrame': 'Pre-six weeks of investigational drug and placebo intervention'}, {'measure': 'Maximal exercise capacity and oxygen consumption', 'timeFrame': 'Pre-six weeks of investigational drug and placebo intervention'}, {'measure': 'Resting and post-exercise ventricular systolic and diastolic function', 'timeFrame': 'Pre-six weeks of investigational drug and placebo intervention', 'description': 'Standard and novel echocardiographic measures including strain/strain rate'}, {'measure': 'Urinary 8-isoprostanes', 'timeFrame': 'Pre-six weeks of investigational drug and placebo intervention', 'description': 'Measure of oxidative stress'}, {'measure': 'Heart failure related quality of life', 'timeFrame': 'Pre-six weeks of investigational drug and placebo intervention', 'description': 'Minnesota Living With Heart Failure Questionnaire'}, {'measure': '24-hour blood pressure', 'timeFrame': 'Post-six weeks of investigational drug and placebo intervention', 'description': 'Mean and diurnal variation'}, {'measure': 'EndoPAT arterial endothelial function', 'timeFrame': 'Post-six weeks of investigational drug and placebo intervention', 'description': 'Plethysmographic measure of resistance arterial endothelial function'}, {'measure': 'Carotid-femoral pulse wave velocity', 'timeFrame': 'Post-six weeks of investigational drug and placebo intervention'}, {'measure': 'Maximal exercise capacity and oxygen consumption', 'timeFrame': 'Post-six weeks of investigational drug and placebo intervention'}, {'measure': 'Resting and post-exercise ventricular systolic and diastolic function', 'timeFrame': 'Post-six weeks of investigational drug and placebo intervention', 'description': 'Standard and novel echocardiographic measures including strain/strain rate'}, {'measure': 'Urinary 8-isoprostanes', 'timeFrame': 'Post-six weeks of investigational drug and placebo intervention', 'description': 'Measure of oxidative stress'}, {'measure': 'Heart failure related quality of life', 'timeFrame': 'Post-six weeks of investigational drug and placebo intervention', 'description': 'Minnesota Living With Heart Failure Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Endothelial function', 'Antioxidants', 'Oxidative stress', 'Grapes', 'Polyphenols', 'Resveratrol', 'Quercetin', 'Anthocyanins', 'Flavanols', 'Flavonols', 'Congestive heart failure', 'Heart failure with normal ejection fraction', 'Heart failure with preserved systolic function', 'HFNEF', 'HFPSF', 'HFPEF', 'DHF'], 'conditions': ['Diastolic Heart Failure', 'Hypertensive Heart Disease', 'Heart Failure With Preserved Ejection Fraction', 'Hypertension', 'Oxidative Stress']}, 'referencesModule': {'references': [{'pmid': '18948553', 'type': 'BACKGROUND', 'citation': 'Seymour EM, Singer AA, Bennink MR, Parikh RV, Kirakosyan A, Kaufman PB, Bolling SF. Chronic intake of a phytochemical-enriched diet reduces cardiac fibrosis and diastolic dysfunction caused by prolonged salt-sensitive hypertension. J Gerontol A Biol Sci Med Sci. 2008 Oct;63(10):1034-42. doi: 10.1093/gerona/63.10.1034.'}, {'pmid': '17513948', 'type': 'BACKGROUND', 'citation': 'Ma L, Gao HQ, Li BY, Ma YB, You BA, Zhang FL. Grape seed proanthocyanidin extracts inhibit vascular cell adhesion molecule expression induced by advanced glycation end products through activation of peroxisome proliferators-activated receptor gamma. J Cardiovasc Pharmacol. 2007 May;49(5):293-8. doi: 10.1097/FJC.0b013e31803c5616.'}, {'pmid': '19608210', 'type': 'BACKGROUND', 'citation': 'Sivaprakasapillai B, Edirisinghe I, Randolph J, Steinberg F, Kappagoda T. Effect of grape seed extract on blood pressure in subjects with the metabolic syndrome. Metabolism. 2009 Dec;58(12):1743-6. doi: 10.1016/j.metabol.2009.05.030. Epub 2009 Jul 15.'}, {'pmid': '19646193', 'type': 'BACKGROUND', 'citation': 'Kar P, Laight D, Rooprai HK, Shaw KM, Cummings M. Effects of grape seed extract in Type 2 diabetic subjects at high cardiovascular risk: a double blind randomized placebo controlled trial examining metabolic markers, vascular tone, inflammation, oxidative stress and insulin sensitivity. Diabet Med. 2009 May;26(5):526-31. doi: 10.1111/j.1464-5491.2009.02727.x.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion:\n\n* Signs and symptoms of heart failure\n* Left ventricular ejection fraction ≥ 50% (contrast ventriculography, echocardiography, nuclear scintigraphy, MRI or CT imaging)\n* Diastolic dysfunction on previous echocardiogram/catheterization, or indeterminate diastolic function with supporting evidence of heart failure (HF) (as per European Society of Cardiology guidelines)\n* History of systemic hypertension\n* Age ≥ 50 years\n* Willing to adhere to prescribed course of supplementation\n* Informed consent\n\nExclusion Criteria:\n\n* Daily intake of antioxidant supplements or vitamins beyond that provided in a standard daily multivitamin (e.g. high-dose vitamin E or vitamin C)\n* NYHA Class IV heart failure symptoms (except during previous hospitalization)\n* Hospitalization for decompensated heart failure within past one month\n* Severely uncontrolled hypertension (SBP ≥ 180 and.or DBP ≥ 100 at rest, on current antihypertensive regimen\n* Uncontrolled diabetes mellitus (hemoglobin A1C \\> 9%)\n* Severe renal (estimated GFR \\< 30 ml/min) or hepatic disease/failure\n* Severe anemia (Hgb \\< 9)\n* Primary exercise limitation due to severe pulmonary disease\n* Unacceptably poor echocardiographic images for analysis\n* Worse than moderate mitral or aortic stenosis or insufficiency.\n* Non-hypertensive cause of HFpEF (e.g. valvular disease, congenital heart disease, amyloidosis, sarcoidosis, constrictive pericardial syndromes)\n* Myocardial infarction or unstable angina, including new or worsening anginal syndrome, within the past three months\n* Uncontrolled arrhythmia (including non rate-controlled atrial fibrillation)\n* Terminal illness expected to result in death within six months or active solid-organ cancer\n* Psychiatric disorder (or dementia) with potential to compromise adherence\n* Changes in medical regimen for heart disease or hypertension within past 1 month (except diuretic dose adjustment)'}, 'identificationModule': {'nctId': 'NCT01185067', 'acronym': 'GRAPEVINE-HF', 'briefTitle': 'Physiological Effects of Grape Seed Extract in Diastolic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'GRAPe Seed Extract and Ventriculovascular Investigation in Normal Ejection-Fraction Heart Failure', 'orgStudyIdInfo': {'id': 'HUM00029626'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'grape seed extract capsule', 'description': 'Grape seed extract (MegaNatural BP, Polyphenolics, Inc.) 300 milligram capsules twice daily for six weeks', 'interventionNames': ['Drug: grape seed extract (MegaNatural BP, Polyphenolics, Inc.)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'maltodextrin capsule', 'description': 'Maltodextrin capsules (matched for appearance and taste to grape seed extract capsules) twice daily for six weeks', 'interventionNames': ['Drug: grape seed extract (MegaNatural BP, Polyphenolics, Inc.)']}], 'interventions': [{'name': 'grape seed extract (MegaNatural BP, Polyphenolics, Inc.)', 'type': 'DRUG', 'otherNames': ['grapes', 'wine', 'polyphenols', 'resveratrol', 'quercetin', 'anthocyanins', 'flavonoids', 'flavanols', 'flavonols', 'antioxidants'], 'description': '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.', 'armGroupLabels': ['grape seed extract capsule', 'maltodextrin capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Scott L Hummel, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Scott L. Hummel', 'investigatorAffiliation': 'University of Michigan'}}}}