NCT00317967

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2006

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 9, 2013

Status Verified

December 1, 2013

Enrollment Period

3.5 years

First QC Date

April 24, 2006

Last Update Submit

December 5, 2013

Conditions

Hypertrophic Cardiomyopathy

Keywords

Hypertrophic cardiomyopathyStatin therapyRegressionHeart failureArrhythmiasSudden cardiac death

Outcome Measures

Primary Outcomes (1)

  • Change in left ventricular mass at 12 months from baseline

    12 months

Secondary Outcomes (5)

  • a decrease in maximal ventricular wall cross sectional width

    12 months

  • a decrease in the incidence of nonsustained ventricular tachycardia

    12 months

  • a decrease in T-wave alternans

    12 months

  • a decrease in the volume of dense myocardial fibrosis

    12 months

  • parameters of diastolic function

    12 months

Study Arms (2)

1

EXPERIMENTAL

Atorvastatin

Drug: Atorvastatin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AtorvastatinDRUG

80 mg pills daily

1
PlaceboDRUG

80 mg pills daily

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary, Faculty of Medicine

Calgary, Alberta, T2N 4N1, Canada

Location

Related Publications (1)

  • 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.

    PMID: 28400935DERIVED

MeSH Terms

Conditions

Cardiomyopathy, HypertrophicHeart FailureArrhythmias, CardiacDeath, Sudden, Cardiac

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart ArrestDeath, SuddenDeath

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Robert S. Sheldon, MD, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiac Sciences, Medicine and Medical Genetics

Study Record Dates

First Submitted

April 24, 2006

First Posted

April 25, 2006

Study Start

April 1, 2007

Primary Completion

October 1, 2010

Study Completion

November 1, 2010

Last Updated

December 9, 2013

Record last verified: 2013-12

Locations

CA(1)