The Effect of Statin Use on Vascular Function in Hypertensive Subjects

NCT00181181 | Terminated Phase 4

• 1 other identifier: HBV03-03-03-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to find if treatment with atorvastatin, a drug that reduces cholesterol, improves the function of blood vessels among people with high blood pressure. Adults with mildly high blood pressure, or who are taking medication for high blood pressure but are otherwise healthy may join, with the approval of their health care provider. The study period is 14-17 weeks. Approximately 50 to 60 subjects will take part in the study.

Conditions

Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

• To investigate the effect of statin therapy on vascular function,on coronary microvascular function, on markers of inflammation and NO metabolites ,and on skin cholesterol of hypertensive subjects.

  microvascular function by echo doppler of coronary flow

  3 months

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

Atorvastatin for 3 months

Drug: atorvastatin

Placebo

PLACEBO COMPARATOR

Other: placebo

Interventions

atorvastatin DRUG

Atorvastatin 80 mg daily for 3 months

Atorvastatin

placebo OTHER

placebo daily

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 20-75 years of age.
• The subjects will have a sitting systolic blood pressure measurement of 140-159 mm Hg (measured using JNC VI procedures) OR a prescription verified history of the use of stable (for 3 months) antihypertensive medication (certain drugs are excluded below). Potential subjects not on therapy who have a systolic BP of 140-159 mmHg will be advised on diet and lifestyle changes according to JNC VI guidelines prior to study participation.
• They must be able to give informed consent.

You may not qualify if:

• Subjects currently using lipid-lowering medication such as statins, niacin or gemfibrozil.
• Systolic BP \> 159 mmHg or diastolic BP \> 99 mmHg despite anti-hypertensive medication. Subjects who have blood pressure readings above these values will be given a trial of antihypertensive therapy for two weeks using the drugs hydrochlorthiazide and/or metoprolol with permission from them and their primary healthcare provider. If controlled, they will be allowed to enroll.
• Subjects on clonidine. Subjects on clonidine who express interest in the study will be considered if their primary health care provider permits the investigators to change them on to allowed antihypertensive medication, i.e., hydrochlorthiazide or metoprolol, and they meet enrollment criteria after two weeks of therapy.
• Subjects on ACE inhibitors or calcium channel blockers who express interest in the study will be considered if their primary health care provider permits the investigators to change them on to allowed antihypertensive medication, i.e., hydrochlorthiazide or metoprolol, and they meet enrollment criteria after two weeks of therapy. If beta-blocker/diuretic treatment is not effective or not tolerated, or if advised by the subject's primary health care provider, subjects may remain in the study on ACE inhibitors or calcium channel blockers.
• Subjects being treated with antifungal agents or the antibiotic erythromycin.
• Women using oral contraceptive drugs.
• Diabetic patients that are not on antihypertensive medication.
• Subjects who have EKG abnormalities during the screening visit, ischemic EKG abnormalities on stress testing, or history of prior diagnosis of ischemic heart disease, or use of digoxin, nitroglycerine/anti-anginal agents, theophylline-like drugs or antiarrhythmic medication.
• Subjects with a history of chronic obstructive airway disease, or evidence of such disease at clinical examination during the screening visit. (x) Persons who are current smokers.
• Subjects with abnormal liver and renal function tests at screening visit. - Women who are pregnant (by history or pregnancy test) or are planning pregnancy during the study period, or are nursing infants.
• Persons with severe obesity defined as BMI \> 40 kg/m2.

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Heart Association: collaborator
• Procris Pharmaceuticals: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Pamela Ouyang, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: May 1, 2003
• Primary Completion: June 1, 2006
• Study Completion: April 1, 2007
• Last Updated: May 28, 2010

Record last verified: 2006-09

Locations

US (1)