Nitric Oxide Mediated Vasodilatory Response to Hawthorn S... | NCT01331486

Studies
Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

NCT01331486

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Feb 7, 2013Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Prehypertension
Mild Hypertension

Interventions

Hawthorn
Placebo capsule

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Apr 6, 2011

First Submission Date that Met QC Criteria

Apr 7, 2011

First Posted Date

Apr 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2013

Last Update Posted Date

Feb 7, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Hawthorn	Dietary Supplement	Hawthorn standardized extract liquid capsule	High dose Low dose Mid dose

Measure	Description	Time Frame
FMD Max	Brachial artery flow mediated dilation max (%)	7d

Measure	Description	Time Frame
BP	Blood pressure	7d

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Gary N Asher, MD, MPH	UNC	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UNC Department of Family Medicine		Chapel Hill	North Carolina	27599	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22458601	Result	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.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases