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Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

NCT01331486•University of North Carolina, Chapel Hill

Summary

Prehypertension and mild hypertension affect an estimated 157 million U.S. adults. Cardiovascular disease (CVD) risk and associated mortality is elevated in this population. Treatment options are limited consisting of lifestyle modification, which is often ineffective, or drug therapy, which carries risk of side effects. Highly safe, efficacious, and acceptable treatment options for this population are needed. Hawthorn standardized extract (HSE) is approved for use in Europe to treat heart failure, and preliminary evidence suggests it may have a blood pressure lowering effect. However, prior trials of hawthorn have based dosage recommendations on animal studies. Therefore, the investigators propose a dose-finding study to measure the pharmacodynamic effect of three doses of standardized hawthorn extract and placebo.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Recent ambulatory daytime systolic BP average between 120 - 155 mmHg or diastolic BP between 80-95 mmHg
•2. Age 18 years and older.
•3. Ability to speak English

Exclusion Criteria

•1. Any antihypertensive medication use (ACE inhibitors, ARB, beta-blockers, calcium channel blockers, diuretics, alpha agonists or antagonists, nitrates, direct vasodilators such as hydralazine, aldosterone antagonists, direct renin inhibitors, endothelin antagonists)
•2. Current tobacco use.
•3. Diagnosed with diabetes, known coronary artery disease, severe aortic stenosis, idiopathic hypertrophic subaortic stenosis (IHSS), or upper extremity vascular obstruction.
•4. Pregnancy or breast feeding.
•5. Using estrogen-containing birth control methods.
•6. Unwillingness to forgo vitamins C and E, fish oil, niacin, arginine, OTC decongestants, and NSAIDs such as advil, motrin, and nuprin during the study period.
•7. Unwillingness to forgo use of phosphodiesterase inhibitors (sildenafil - 36 hours, vardenafil - 36 hours, tadalafil - 96 hours) prior to study visits.
•8. Unwillingness to refrain from vigorous exercise on the morning of study visits.
•9. Women with childbearing potential who do not agree to practice effective birth control (condom, diaphragm, cervical cap, copper IUD, abstinence).

Locations (1)

UNC Department of Family Medicine

Chapel Hill, North Carolina, United States

Key Dates

Start Date

May 1, 2010

Primary Completion Date

June 1, 2011

Completion Date

June 1, 2011

Last Updated

February 7, 2013

Enrollment

ACTUAL participants

Conditions

PrehypertensionMild Hypertension

Interventions

Hawthorn

DIETARY_SUPPLEMENT

Placebo capsule

DIETARY_SUPPLEMENT

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ENROLLING_BY_INVITATIONNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

Inclusion Criteria

Exclusion Criteria

Evaluation of Physical Fitness and Hemodynamics Across a Diverse Population

Pranayama and Jacobson's Progressive Muscle Relaxation Technique in Pre-hypertensive Patients

Project WHADE: A Partner-Based Physical Activity Program for Women

Effect of Aerobic Exercise with Blood Flow Restriction on Post-exercise Hypotension in Young Adults: the Role of Histamine Receptors

Effect of 7 Days of Grape Seed Extract Supplementation on Cold Pressor Test and Muscle Metaboreflex in Individuals With Elevated and Stage 1 Hypertension

Potassium Supplementation to Reduce Blood Pressure