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Adult Trials: 18+ Years
- 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.
- 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)
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- Cleveland, Ohio
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | The Effect of Lipitor on Aortic Stenosis | |||
| Official Title ICMJE | The Effect of Statin Therapy (Atorvastatin) on the Progression of Calcific Valvular Aortic Stenosis | |||
| Brief Summary | 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. | |||
| 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. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Aortic Valve Stenosis | |||
| Intervention ICMJE | Drug: atorvastatin (Lipitor)
atorvastatin 40 mg by mouth once daily Other Name: Lipitor | |||
| Study Arms ICMJE | Experimental: AORTIC STENOSIS PATIENTS
Atorvastatin (Lipitor) 40mg by mouth daily is administered to patients with aortic stenosis Intervention: Drug: atorvastatin (Lipitor) | |||
| Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Actual Enrollment ICMJE | 59 | |||
| Original Actual Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | April 26, 2010 | |||
| Actual Primary Completion Date | April 26, 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00590135 | |||
| Other Study ID Numbers ICMJE | IRB 3516 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE |
| |||
| Responsible Party | The Cleveland Clinic | |||
| Study Sponsor ICMJE | The Cleveland Clinic | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | The Cleveland Clinic | |||
| Verification Date | July 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||