The Effect of Statin Use on Vascular Function in Hypertensive Subjects

This study has been terminated.
(Coronary flow by echo Doppler was obtainable in about 50% of subjects. The study was stopped early because of insufficient sample size to achieve adequate power)
Sponsor:
Collaborators:
American Heart Association
Procris Pharmaceuticals
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181181
First received: September 13, 2005
Last updated: May 27, 2010
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: atorvastatin
Other: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Statin Use on Vascular Function in Hypertensive Subjects

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    microvascular function by echo doppler of coronary flow


Enrollment: 24
Study Start Date: May 2003
Study Completion Date: April 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atorvastatin
Atorvastatin for 3 months
Drug: atorvastatin
Atorvastatin 80 mg daily for 3 months
Placebo Comparator: Placebo Other: placebo
placebo daily

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  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: NCT00181181

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
American Heart Association
Procris Pharmaceuticals
Investigators
Principal Investigator: Pamela Ouyang, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Pamela Ouyang MBBS, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00181181     History of Changes
Other Study ID Numbers: HBV03-03-03-02
Study First Received: September 13, 2005
Last Updated: May 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014