Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract - Full Text View

Purpose

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.

Condition	Intervention	Phase
Prehypertension Mild Hypertension	Dietary Supplement: Hawthorn Dietary Supplement: Placebo capsule	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title:	Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Nitric oxide

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

FMD Max [ Time Frame: 7d ] [ Designated as safety issue: No ]
Brachial artery flow mediated dilation max (%)

Secondary Outcome Measures:

BP [ Time Frame: 7d ] [ Designated as safety issue: No ]
Blood pressure

Enrollment:	24
Study Start Date:	May 2010
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo capsule	Dietary Supplement: Placebo capsule Matched placebo liquid capsule
Active Comparator: Low dose	Dietary Supplement: Hawthorn Hawthorn standardized extract liquid capsule Other Name: Gaia Hawthorn Supreme
Active Comparator: Mid dose	Dietary Supplement: Hawthorn Hawthorn standardized extract liquid capsule Other Name: Gaia Hawthorn Supreme
Active Comparator: High dose	Dietary Supplement: Hawthorn Hawthorn standardized extract liquid capsule Other Name: Gaia Hawthorn Supreme

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331486

Locations

United States, North Carolina
UNC Department of Family Medicine
Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Investigators

Principal Investigator:

Gary N Asher, MD, MPH

UNC

More Information

Publications:

Asher GN, Viera AJ, Weaver MA, Dominik R, Caughey M, Hinderliter AL. Effect of hawthorn standardized extract on flow mediated dilation in prehypertensive and mildly hypertensive adults: a randomized, controlled cross-over trial. BMC Complement Altern Med. 2012 Mar 29;12:26.

Responsible Party:	University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT01331486 History of Changes
Other Study ID Numbers:	09-2279
Study First Received:	April 6, 2011
Last Updated:	February 6, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:

Prehypertension
Mild hypertension
Flow mediated dilation
Hawthorn

Additional relevant MeSH terms:

Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents

Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013