The Effect of Lipitor on Aortic Stenosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by The Cleveland Clinic.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00590135
First received: December 26, 2007
Last updated: January 9, 2008
Last verified: May 2007
  Purpose

The purpose of this study is to find out if an approved medicine that is used to lower cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve in patients with a condition called aortic stenosis. Patients who have aortic stenosis who volunteer for this study will take Lipitor for 2 years and will undergo a brief exam by a physician, labwork to measure cholesterol, and a routine heart ultrasound (sound picture of the heart) at the start of the study and every 6 months, stopping at 2 years.


Condition Intervention Phase
Aortic Valve Stenosis
Drug: atorvastatin (Lipitor)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Statin Therapy (Atorvastatin) on the Progression of Calcific Valvular Aortic Stenosis

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Rate of change in the aortic valve area as measured by transthoracic echocardiography [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of change in the aortic valve area measured by transthoracic echocardiography compared to that of historical controls [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Rate of change in aortic valve area as measured by transthoracic echocardiography compared to standard of care group [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change in the mean and peak gradients across the aortic valve as measured by transthoracic echocardiography in the treated group compared to historical control group. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: August 2000
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AS
Patients with mild to moderate calcific aortic stenosis
Drug: atorvastatin (Lipitor)
atorvastatin 40 mg by mouth once daily
Other Name: Lipitor

Detailed Description:

This is a prospective, single-center study assessing the effect of atorvastatin 40 mg/day (Lipitor, Pfizer) on the progression of calcific aortic stenosis in approximately 70 patients with mild to moderate calcific AS of a tricuspid or bicuspid aortic valve. As a control population, published data on historical AS cohorts will be used, employing the accepted rate of progression of a decrease in aortic valve area of 0.1 cm²/year. Additionally, also for comparison, we will prospectively study a registry of AS patients who meet our entry criteria but are either currently already being treated with or refuse to take an HMG-CoA reductase inhibitor (referred to as the "standard care" group).

All patient visits, laboratory studies, and echocardiograms will be performed at the Cleveland Clinic Foundation in Cleveland, Ohio with the exception of the 12-week visit ALT measurement which may be done at the patient's local doctor's office and the results faxed to Imaging Research. The 12-week follow-up assessment may be completed over the phone to establish any change in patient status since baseline, study medication compliance, concomitant medication use and to ascertain whether or not the appropriate laboratory test was obtained. Over a 2-year period, assessments will be conducted at baseline, 6, 12, 18, and 24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate calcific AS of a tricuspid or bicuspid aortic valve
  • Echocardiographic derived mean pressure gradient >10 mmHg and an aortic valve area of 0.9 to 1.7 cm2 by continuity equation.
  • Laboratory evidence of LDL-c>70 mg/dl within 12 months prior to recruitment.

Exclusion Criteria:

  • Left ventricular ejection fraction <50%
  • Valvular area of 0.9 cm2 and a mean gradient >30 mmHg
  • Rheumatic heart disease
  • >Moderate (2+) aortic insufficiency
  • Prior statin therapy to include: >10 mg of atorvastatin (Lipitor) or >20 mg of other HMG-CoA Reductase Inhibitors (statins)
  • End-stage renal disease (ESRD)
  • History of thoracic radiation
  • Unable or unwilling to sign informed consent
  • Unable to unwilling to return for follow-up
  • Other clinically important renal, pulmonary, hepatic, neurological, endocrine, or hematological disorders, vasculitis, or any other situation or medical condition that, in the investigator's opinion, would make survival for the duration of the study unlikely, or would otherwise interfere with optimal participation in the study or produce a significant risk to the patient
  • Severe pulmonary hypertension (>55 mmHg)
  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: NCT00590135

Locations
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Pfizer
Investigators
Principal Investigator: Brian P Griffin, M.D. The Cleveland Clinic
  More Information

Publications:

Responsible Party: Brian P. Griffin, M.D., The Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT00590135     History of Changes
Other Study ID Numbers: IRB 3516
Study First Received: December 26, 2007
Last Updated: January 9, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
calcific aortic valve stenosis
echocardiography, transthoracic

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical
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 28, 2014