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The Effect of Lipitor on Aortic Stenosis

This study has been terminated.
(Poor Reducibility - primary endpoint measure not obtainable)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00590135
First Posted: January 10, 2008
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
The Cleveland Clinic
  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: Intervention Model: Single Group Assignment
Masking: None (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:
  • Aortic Stenosis [ Time Frame: 2 years ]
    aortic valve area as measured by transthoracic echocardiography was not obtained due to poor reproducibility


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 ]
    Rate of change in the aortic valve area measured by transthoracic echocardiography compared to that of historical controls was not obtained. Primary outcome measurement was not obtainable, thus comparison to historic controls was not possible.

  • Rate of Change in the Aortic Valve Area Measured by TEE Compared to That of Historical Controls [ Time Frame: 2 years ]
    Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in primary measure not being obtained. As the outcome measurement was not obtained, comparison to historical controls was not possible.

  • Rate of Change in Aortic Valve Area as Measured by TEE Compared to Standard of Care Group [ Time Frame: 2 years ]
    Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. Thus, comparison to the stand of care group was not possible.

  • Change in Mean and Peak Gradients Across the Aortic Valve as Measured by TEE in the Treated Group Compared to Historical Control Group. [ Time Frame: 2 years ]
    Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. This secondary measurement was not obtained as it was deemed not relevant in the absence of the primary outcome measurement and other secondary outcome measurements.


Enrollment: 59
Actual Study Start Date: August 2000
Study Completion Date: April 26, 2010
Primary Completion Date: April 26, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AORTIC STENOSIS PATIENTS
Atorvastatin (Lipitor) 40mg by mouth daily is administered to patients with 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00590135     History of Changes
Other Study ID Numbers: IRB 3516
First Submitted: December 26, 2007
First Posted: January 10, 2008
Results First Submitted: April 18, 2017
Results First Posted: July 26, 2017
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors