Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

Prehypertension Clinical Trial

Official title:

Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331486
• Other study ID #: 09-2279
• Status: Completed
• Phase: Phase 1
• First received: April 6, 2011
• Last updated: February 6, 2013
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Mild Hypertension
• Prehypertension

Intervention

Dietary Supplement:
• Hawthorn
Hawthorn standardized extract liquid capsule
• Placebo capsule
Matched placebo liquid capsule

Locations

Country	Name	City	State
United States	UNC Department of Family Medicine	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FMD Max	Brachial artery flow mediated dilation max (%)	7d	No
Secondary	BP	Blood pressure	7d	No