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Aortic Valve StenosisPhase 4NCT00590135

The Effect of Lipitor on Aortic Stenosis

A Phase 4 study testing atorvastatin (Lipitor) in people with Aortic Valve Stenosis, run by The Cleveland Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
atorvastatin (Lipitor)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteUnited States
Study dates
Aug 2000to 26 Apr 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 11Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
atorvastatin (Lipitor)
Keywords
calcific aortic valve stenosis, echocardiography, transthoracic
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • atorvastatin (Lipitor)Drug

    Also called Lipitor

    atorvastatin 40 mg by mouth once daily

Study groups in NCT00590135
Study groupRoleWhat they receive
AORTIC STENOSIS PATIENTSExperimentalAtorvastatin (Lipitor) 40mg by mouth daily is administered to patients with aortic stenosis
Receives: Drug: atorvastatin (Lipitor)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aortic Stenosis

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

    Measured: 2 years

Secondary outcomes (4)

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

    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.

    Measured: 2 years

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

    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.

    Measured: 2 years

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

    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.

    Measured: 2 years

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

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2008 (estimated)
  2. Study startAug 2000
  3. Primary completion26 Apr 2010
  4. Study completion26 Apr 2010

Why it stopped: Poor Reducibility - primary endpoint measure not obtainable

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00590135
Sponsor's protocol ID
IRB 3516
Status last verified
Jul 2017
First submitted
26 Dec 2007
Last updated
26 Jul 2017
Data monitoring committee
No
Individual data sharing
No

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

    PubMed 3807436

  • 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.

    PubMed 4098425

  • 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.

    PubMed 7519131

  • 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.

    PubMed 10047619

  • 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.

    PubMed 8624774

  • 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.

    PubMed 11564401

  • 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.

    PubMed 3812284

  • 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.

    PubMed 1951006

  • 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.

    PubMed 2918158

  • 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.

    PubMed 2301222

  • 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.

    PubMed 1626512

  • 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.

    PubMed 8404089

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing atorvastatin (Lipitor) in people with Aortic Valve Stenosis, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aortic Stenosis (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00590135, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.

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