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The Effect of Lipitor on Aortic Stenosis

Information source: The Cleveland Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Aortic Valve Stenosis

Intervention: atorvastatin (Lipitor) (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: The Cleveland Clinic

Official(s) and/or principal investigator(s):
Brian P Griffin, M.D., Principal Investigator, Affiliation: The Cleveland Clinic

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.

Clinical Details

Official title: The Effect of Statin Therapy (Atorvastatin) on the Progression of Calcific Valvular Aortic Stenosis

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Rate of change in the aortic valve area as measured by transthoracic echocardiography

Secondary outcome:

Rate of change in the aortic valve area measured by transthoracic echocardiography compared to that of historical controls

Rate of change in aortic valve area as measured by transthoracic echocardiography compared to standard of care group

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.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

The Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States
Additional Information

Related publications:

Passik CS, Ackermann DM, Pluth JR, Edwards WD. Temporal changes in the causes of aortic stenosis: a surgical pathologic study of 646 cases. Mayo Clin Proc. 1987 Feb;62(2):119-23.

Walton KW, Williamson N, Johnson AG. The pathogenesis of atherosclerosis of the mitral and aortic valves. J Pathol. 1970 Jul;101(3):205-20.

Otto CM, Kuusisto J, Reichenbach DD, Gown AM, O'Brien KD. Characterization of the early lesion of 'degenerative' valvular aortic stenosis. Histological and immunohistochemical studies. Circulation. 1994 Aug;90(2):844-53.

Kawaguchi A, Miyatake K, Yutani C, Beppu S, Tsushima M, Yamamura T, Yamamoto A. Characteristic cardiovascular manifestation in homozygous and heterozygous familial hypercholesterolemia. Am Heart J. 1999 Mar;137(3):410-8.

O'Brien KD, Reichenbach DD, Marcovina SM, Kuusisto J, Alpers CE, Otto CM. Apolipoproteins B, (a), and E accumulate in the morphologically early lesion of 'degenerative' valvular aortic stenosis. Arterioscler Thromb Vasc Biol. 1996 Apr;16(4):523-32.

Chan KL, Ghani M, Woodend K, Burwash IG. Case-controlled study to assess risk factors for aortic stenosis in congenitally bicuspid aortic valve. Am J Cardiol. 2001 Sep 15;88(6):690-3.

Hofmann T, Kasper W, Meinertz T, Spillner G, Schlosser V, Just H. Determination of aortic valve orifice area in aortic valve stenosis by two-dimensional transesophageal echocardiography. Am J Cardiol. 1987 Feb 1;59(4):330-5.

Stoddard MF, Arce J, Liddell NE, Peters G, Dillon S, Kupersmith J. Two-dimensional transesophageal echocardiographic determination of aortic valve area in adults with aortic stenosis. Am Heart J. 1991 Nov;122(5):1415-22.

Otto CM, Pearlman AS, Gardner CL. Hemodynamic progression of aortic stenosis in adults assessed by Doppler echocardiography. J Am Coll Cardiol. 1989 Mar 1;13(3):545-50.

Roger VL, Tajik AJ, Bailey KR, Oh JK, Taylor CL, Seward JB. Progression of aortic stenosis in adults: new appraisal using Doppler echocardiography. Am Heart J. 1990 Feb;119(2 Pt 1):331-8.

Faggiano P, Ghizzoni G, Sorgato A, Sabatini T, Simoncelli U, Gardini A, Rusconi C. Rate of progression of valvular aortic stenosis in adults. Am J Cardiol. 1992 Jul 15;70(2):229-33.

Peter M, Hoffmann A, Parker C, Lüscher T, Burckhardt D. Progression of aortic stenosis. Role of age and concomitant coronary artery disease. Chest. 1993 Jun;103(6):1715-9.

Starting date: August 2000
Last updated: January 9, 2008

Page last updated: August 23, 2015

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