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NCT01185067 · ClinicalTrials.gov registry record · Phase 1
Physiological Effects of Grape Seed Extract in Diastolic Heart Failure
A Phase 1 study of Hypertension and Heart Failure With Preserved Ejection Fraction, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT01185067 is a Phase 1 study of Hypertension and Heart Failure With Preserved Ejection Fraction that has completed, run by University of Michigan. The registered enrollment target is 15 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01185067, a Phase 1 study of Hypertension and Heart Failure With Preserved Ejection Fraction, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
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-we
Conditions Studied
Interventions
- DRUG grape seed extract (MegaNatural BP, Polyphenolics, Inc.)
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-02-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01185067
The ClinicalTrials.gov registry entry for NCT01185067 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (100% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which grape seed extract (MegaNatural BP, Polyphenolics, Inc.) is the first listed.
NCT01185067 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT01185067 about?
NCT01185067 is a clinical study titled "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...
What is the current status of trial NCT01185067?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2010-10. Estimated completion is 2014-02-24.
What conditions does trial NCT01185067 study?
This clinical trial studies the following conditions: Hypertension, Heart Failure With Preserved Ejection Fraction, Oxidative Stress, Diastolic Heart Failure, Hypertensive Heart Disease.
What interventions are being tested in trial NCT01185067?
The interventions under investigation include: grape seed extract (MegaNatural BP, Polyphenolics, Inc.) (DRUG).
Who is sponsoring clinical trial NCT01185067?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01185067 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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