Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00180258

Purpose

The purpose of this study is to determine whether combined mortality and hospitalization in heart failure patients receiving optimal pharmacologic therapy can be reduced by combining optimal pharmacologic therapy and 1) biventricular pacing therapy alone or 2) biventricular pacing with defibrillation.

Condition	Intervention	Phase
Congestive Heart Failure	Device: Cardiac Resynchronization Therapy with & without defibrillator	Phase II Phase III

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Combination of all-cause mortality and first hospitalization (time to first event), where all-cause mortality is defined as death from all causes.

Secondary Outcome Measures:

Total survival for both the CONTAK CD and CONTAK TR CHFDs when used in conjunction with pharmacologic therapy.

Estimated Enrollment:	2200
Study Start Date:	January 2000
Estimated Study Completion Date:	December 2002

Detailed Description:

Evaluation of new therapies for the treatment of heart failure should address mortality, morbidity, hospitalization, and cardiac symptoms and function when compared to standard pharmacologic therapy. The COMPANION trial is designed to address all of these objectives. This clinical investigation is an open-label, prospective, multi-center, randomized clinical trial. Every patient enrolled in the study is to be prescribed to optimal pharmacologic heart failure therapy, as tolerated, regardless of randomization.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Moderate or severe heart failure, defined as symptomatic heart failure for at least six months with NYHA Class III or IV symptoms at the time of enrollment, AND at least one of the following events in the previous 12 months:
Hospitalization for heart failure management
Outpatient visit in which intravenous (IV) inotropes or vasoactive infusion were administered continuously for at least 4 hours
Emergency room visit of at least twelve hours duration in which IV heart failure medications were administered (including diuretics)
QRS > or = 120 ms and PR interval > 150 ms from any two leads of a 12-lead ECG
Left ventricular ejection fraction < or = 35%
Left ventricular end diastolic dimension > or = 60 mm (required only if LVEF measured by echo) or > 3.0 cm/m2 [The cm/m2 is calculated by LVEDD (in cm) divided by BSA (body surface area)].
Age > or = 18 years
Optimal pharmacologic therapy for heart failure

Exclusion Criteria:

Unable or unwilling to undergo device implant and follow-up testing
Meet the general indications for an implantable cardioverter defibrillator
Meet the general indications for antibradycardia pacing
Expected to receive a heart transplant in the next six months
Chronic, medically refractory atrial tachyarrhythmias
Unexplained syncope
Myocardial infarction within 60 days of randomization
History of non-compliance with oral heart failure therapy
Progressive or unstable angina
Uncontrolled blood pressure: Systolic BP > 160 mm Hg or < 85 mm Hg or diastolic BP > 90 mm Hg
Patients with a hypersensitivity to a 0.7 mg nominal dose of dexamethasone acetate
Surgically uncorrected primary valvular heart disease
Coronary artery disease (CAD) in which surgical or percutaneous correction is recent (within 60 days of randomization)
Women who are pregnant or not using medically acceptable birth control
Hypertrophic obstructive cardiomyopathy
Amyloid disease
Hospitalization for heart failure or IV inotropic or vasoactive therapy in excess of 4 hours in the 30 days prior to enrollment
Have a tricuspid prosthesis
Involved in any other investigational studies
Life expectancy < 6 months due to any other medical conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180258

Locations

United States, Minnesota
Multiple locations in the US
St. Paul, Minnesota, United States

Sponsors and Collaborators

Boston Scientific Corporation

More Information

Publications of Results:

Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350(21):2140-50.

Study ID Numbers:	Clinicals0002
Study First Received:	September 9, 2005
Last Updated:	January 23, 2007
ClinicalTrials.gov Identifier:	NCT00180258
Health Authority:	United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:

Cardiac Resynchronization Therapy (CRT)
Heart Failure
Defibrillator
Pacemaker

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009