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Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00180258
First received: September 9, 2005
Last updated: January 23, 2007
Last verified: January 2007
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00180258     History of Changes
Other Study ID Numbers: Clinicals0002
Study First Received: September 9, 2005
Last Updated: January 23, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Cardiac Resynchronization Therapy (CRT)
Heart Failure
Defibrillator
Pacemaker

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014