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Hypertrophic CardiomyopathyPhase 3NCT00317967

Study to Determine if Atorvastatin Reduces Size and Stiffness of Muscle in the Left Ventricle of the Heart

A Phase 3 study testing Atorvastatin in people with Hypertrophic Cardiomyopathy, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if a drug called atorvastatin will reduce the size and stiffness of the muscle in the left ventricle of the heart. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertrophic Cardiomyopathy
What is being tested?
Atorvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
1 siteCanada
Study dates
Apr 2007to Nov 2010
Phase
Phase 3
Are there results?
None posted in the registry

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

  • 18 years and over with HCM in the absence of another cardiac or systemic disease capable of producing a prespecified wall thickening

Who cannot join

  • Required use of statin therapy or intolerance
  • A clinical diagnosis of hypertension
  • Indication for statin therapy for primary or secondary prevention of coronary artery disease
  • Current or anticipated indication in ≤ 1 year for implantable cardioverter defibrillators or other metallic devices preventing cardiac magnetic resonance imaging (MRI).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Calgary, Faculty of Medicine

    Calgary, Alberta, T2N 4N1

Other trials in Canada

About this study

Official title: Statin Induced Regression of Cardiomyopathy Trial - SirCat

The purpose of this study is to determine if a drug called atorvastatin will reduce the size and stiffness of the muscle in the left ventricle of the heart.

Read the detailed description

Hypertrophic cardiomyopathy (HCM) is a primary disorder of the heart characterized by a thickened, fibrotic myocardium, with or without a dynamic left ventricular outflow tract gradient. It is a common heritable cardiovascular disease, with a population prevalence of 0.1% to 0.2%. Symptoms of congestive heart failure are extremely common in patients with HCM. Progression to disabling and debilitating symptoms [New York Heart Association (NYHA) class III and IV] is relatively common, occurring in 15% to 20% of unselected populations. The rate of progression to NYHA class III or IV or death from heart failure or stroke is high, with a relative risk 2.7. Management of symptoms can be very challenging, involve multiple medications, and 5% of patients may develop drug refractory heart failure, requiring invasive intervention. HCM is the most common cause of sudden death among young competitive athletes. Ventricular tachyarrhythmias appear to be the primary mechanism; however, other arrhythmias involved include asystole, rapid atrial fibrillation, and electrical mechanical dissociation. Patients may develop progressive myocardial wall thinning, a reduction in systolic performance, and an increase in left ventricular dimensions. Progressive wall thinning may be especially common in patients with initially severe hypertrophy. There is no cure for this condition. There is now evidence from both animal and human studies of a treatment that promises to reverse hypertrophy - HMG CoA reductase inhibitors. Clearly, studies of treatments that might cause regression of hypertrophy are timely and important.

Being tested
Atorvastatin, Placebo
Keywords
Hypertrophic cardiomyopathy, Statin therapy, Regression, Heart failure, Arrhythmias, Sudden cardiac death
Medical subject headings
Cardiomyopathy, Hypertrophic, Heart Failure, Arrhythmias, Cardiac, Death, Sudden, Cardiac

What participants receive

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

  • AtorvastatinDrug

    80 mg pills daily

  • PlaceboDrug

    80 mg pills daily

Study groups in NCT00317967
Study groupRoleWhat they receive
1ExperimentalAtorvastatin
Receives: Drug: Atorvastatin
2Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

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

  1. Change in left ventricular mass at 12 months from baseline

    Measured: 12 months

Secondary outcomes (5)

  1. a decrease in maximal ventricular wall cross sectional width

    Measured: 12 months

  2. a decrease in the incidence of nonsustained ventricular tachycardia

    Measured: 12 months

  3. a decrease in T-wave alternans

    Measured: 12 months

  4. a decrease in the volume of dense myocardial fibrosis

    Measured: 12 months

  5. parameters of diastolic function

    Measured: 12 months

Timeline

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

  1. First posted25 Apr 2006 (estimated)
  2. Study startApr 2007
  3. Primary completionOct 2010
  4. Study completionNov 2010

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00317967
Sponsor's protocol ID
1-Sheldon
Status last verified
Dec 2013
First submitted
24 Apr 2006
Last updated
9 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Hersi A, Giannoccaro JP, Howarth A, Exner D, Weeks S, Eitel I, Herman RC, Duff H, Ritchie D, Mcrae M, Sheldon R. Statin Induced Regression of Cardiomyopathy Trial: A Randomized, Placebo-controlled Double-blind Trial. Heart Views. 2016 Oct-Dec;17(4):129-135. doi: 10.4103/1995-705X.201784.

    PubMed 28400935

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atorvastatin in people with Hypertrophic Cardiomyopathy, run by University of Calgary at 1 site in Canada.

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 1 inclusion and 4 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: finished, as of the sponsor's last update on 9 Dec 2013. 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 Canada. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in left ventricular mass at 12 months from baseline (time frame: 12 months). 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 NCT00317967, which also lists 1 linked publication.

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 9 Dec 2013.

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