Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01331486
First received: April 6, 2011
Last updated: February 6, 2013
Last verified: December 2011
  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:


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:

  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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Cardiovascular Diseases
Vascular Diseases
Nitric Oxide
Anti-Asthmatic Agents
Antioxidants
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Endothelium-Dependent Relaxing Factors
Free Radical Scavengers
Gasotransmitters
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014