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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: Completed Phase 1 study of Hypertension and Heart Failure With Preserved Ejection Fraction, sponsored by University of Michigan.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Ultrasound measure of conduit artery endothelial function

Conditions Studied

Hypertension Heart Failure With Preserved Ejection Fraction Oxidative Stress Diastolic Heart Failure Hypertensive Heart Disease

Interventions

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

Study Locations (1)

Michigan

  • University of Michigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2010-10
Est. Completion 2014-02-24
Phase Phase 1
University of Michigan

1,327 total trials

What the finished NCT01185067 record still lists

NCT01185067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (100% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01185067's enrollment target sits among peer trials

15 453rd of 470 higher than 17 of 470 other Hypertension trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01185067, the US trial registry maintained by the National Library of Medicine. NCT01185067 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.