The Effect of Lipitor on Aortic Stenosis

NCT00590135 | Terminated Phase 4 Results

• 1 other identifier: IRB 3516
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Keywords

calcific aortic valve stenosis; echocardiography, transthoracic

Outcome Measures

Primary Outcomes (1)

• Aortic Stenosis

  aortic valve area as measured by transthoracic echocardiography was not obtained due to poor reproducibility

  2 years

Secondary Outcomes (4)

• Rate of Change in the Aortic Valve Area Measured by Transthoracic Echocardiography Compared to That of Historical Controls

  2 years

• Rate of Change in the Aortic Valve Area Measured by TEE Compared to That of Historical Controls

  2 years

• Rate of Change in Aortic Valve Area as Measured by TEE Compared to Standard of Care Group

  2 years

• Change in Mean and Peak Gradients Across the Aortic Valve as Measured by TEE in the Treated Group Compared to Historical Control Group.

  2 years

Study Arms (1)

AORTIC STENOSIS PATIENTS

EXPERIMENTAL

Atorvastatin (Lipitor) 40mg by mouth daily is administered to patients with aortic stenosis

Drug: atorvastatin (Lipitor)

Interventions

atorvastatin (Lipitor) DRUG

atorvastatin 40 mg by mouth once daily

Also known as: Lipitor

AORTIC STENOSIS PATIENTS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Pfizer: collaborator

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (12)

• 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. doi: 10.1016/s0025-6196(12)61880-1.

  PMID: 3807436 BACKGROUND

• Walton KW, Williamson N, Johnson AG. The pathogenesis of atherosclerosis of the mitral and aortic valves. J Pathol. 1970 Jul;101(3):205-20. doi: 10.1002/path.1711010302. No abstract available.

  PMID: 4098425 BACKGROUND

• 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. doi: 10.1161/01.cir.90.2.844.

  PMID: 7519131 BACKGROUND

• 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. doi: 10.1016/s0002-8703(99)70485-0.

  PMID: 10047619 BACKGROUND

• 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. doi: 10.1161/01.atv.16.4.523.

  PMID: 8624774 BACKGROUND

• 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. doi: 10.1016/s0002-9149(01)01820-3. No abstract available.

  PMID: 11564401 BACKGROUND

• 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. doi: 10.1016/0002-9149(87)90808-3.

  PMID: 3812284 BACKGROUND

• 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. doi: 10.1016/0002-8703(91)90585-6.

  PMID: 1951006 BACKGROUND

• 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. doi: 10.1016/0735-1097(89)90590-1.

  PMID: 2918158 BACKGROUND

• 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. doi: 10.1016/s0002-8703(05)80024-9.

  PMID: 2301222 BACKGROUND

• 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. doi: 10.1016/0002-9149(92)91280-h.

  PMID: 1626512 BACKGROUND

• Peter M, Hoffmann A, Parker C, Luscher T, Burckhardt D. Progression of aortic stenosis. Role of age and concomitant coronary artery disease. Chest. 1993 Jun;103(6):1715-9. doi: 10.1378/chest.103.6.1715.

  PMID: 8404089 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Brian Griffin MD
• Organization: Cleveland Clinic

Griffib@ccf.org

216-444-6812

Study Officials

• Brian P Griffin, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: August 1, 2000
• Primary Completion: April 26, 2010
• Study Completion: April 26, 2010
• Last Updated: July 26, 2017
• Results First Posted: July 26, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)