NCT01331486

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

February 7, 2013

Status Verified

December 1, 2011

Enrollment Period

1.1 years

First QC Date

April 6, 2011

Last Update Submit

February 6, 2013

Conditions

PrehypertensionMild Hypertension

Keywords

PrehypertensionMild hypertensionFlow mediated dilationHawthorn

Outcome Measures

Primary Outcomes (1)

  • FMD Max

    Brachial artery flow mediated dilation max (%)

    7d

Secondary Outcomes (1)

  • BP

    7d

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo capsule

Dietary Supplement: Placebo capsule

Low dose

ACTIVE COMPARATOR
Dietary Supplement: Hawthorn

Mid dose

ACTIVE COMPARATOR
Dietary Supplement: Hawthorn

High dose

ACTIVE COMPARATOR
Dietary Supplement: Hawthorn

Interventions

HawthornDIETARY_SUPPLEMENT

Hawthorn standardized extract liquid capsule

Also known as: Gaia Hawthorn Supreme
High doseLow doseMid dose
Placebo capsuleDIETARY_SUPPLEMENT

Matched placebo liquid capsule

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Department of Family Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Related 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. 2012 Mar 29;12:26. doi: 10.1186/1472-6882-12-26.

    PMID: 22458601RESULT

MeSH Terms

Conditions

Prehypertension

Interventions

crataegus extract

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Gary N Asher, MD, MPH

    UNC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2011

First Posted

April 8, 2011

Study Start

May 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

February 7, 2013

Record last verified: 2011-12

Locations

US(1)