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OpenTrials
Completed

NCT Number: NCT01331486

Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

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.

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Key information

Conditions

Prehypertension Cardiovascular Diseases Mild Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UNC Department of Family Medicine

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • Current tobacco use.
  • Diagnosed with diabetes, known coronary artery disease, severe aortic stenosis, idiopathic hypertrophic subaortic stenosis (IHSS), or upper extremity vascular obstruction.
  • Pregnancy or breast feeding.
  • Using estrogen-containing birth control methods.
  • 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.
  • Unwillingness to forgo use of phosphodiesterase inhibitors (sildenafil - 36 hours, vardenafil - 36 hours, tadalafil - 96 hours) prior to study visits.
  • Unwillingness to refrain from vigorous exercise on the morning of study visits.
  • Women with childbearing potential who do not agree to practice effective birth control (condom, diaphragm, cervical cap, copper IUD, abstinence).

Treatment and study plan

Hawthorn

Dietary Supplement

Hawthorn standardized extract liquid capsule

Other names: Gaia Hawthorn Supreme

placebo capsule

Dietary Supplement

Matched placebo liquid capsule

Primary outcomes

  1. FMD Max

    Time frame: 7d

    Brachial artery flow mediated dilation max (%)

Secondary outcomes

  1. BP

    Time frame: 7d

    Blood pressure

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 8, 2011
Registry last updated
Feb 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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