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CompletedNCT00180258Updated Jan 25, 2007

Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure

A Phase 2/3 interventional study of Cardiac Resynchronization Therapy with & without defibrillator in Congestive Heart Failure, sponsored by Boston Scientific Corporation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-01-25.

Sponsored by Boston Scientific Corporation · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
2,200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

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Conditions studied

  • Congestive Heart Failure

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Keywords

  • Cardiac Resynchronization Therapy (CRT)
  • Heart Failure
  • Defibrillator
  • Pacemaker
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 2,200 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,200 participants

Interventions

  • DeviceCardiac Resynchronization Therapy with & without defibrillator
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What researchers measure

Primary outcomes

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

Secondary outcomes

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

07

Study locations

1 site
  • Multiple locations in the US
    St. Paul, Minnesota, United States
08

References and documents

Publications

  • 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. doi: 10.1056/NEJMoa032423. PubMed 15152059 ↗
  • Cleland JGF, Bristow MR, Freemantle N, Olshansky B, Gras D, Saxon L, Tavazzi L, Boehmer J, Ghio S, Feldman AM, Daubert JC, de Mets D. The effect of cardiac resynchronization without a defibrillator on morbidity and mortality: an individual patient data meta-analysis of COMPANION and CARE-HF. Eur J Heart Fail. 2022 Jun;24(6):1080-1090. doi: 10.1002/ejhf.2524. Epub 2022 May 22. PubMed 35490339 ↗
  • Anand IS, Carson P, Galle E, Song R, Boehmer J, Ghali JK, Jaski B, Lindenfeld J, O'Connor C, Steinberg JS, Leigh J, Yong P, Kosorok MR, Feldman AM, DeMets D, Bristow MR. Cardiac resynchronization therapy reduces the risk of hospitalizations in patients with advanced heart failure: results from the Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure (COMPANION) trial. Circulation. 2009 Feb 24;119(7):969-77. doi: 10.1161/CIRCULATIONAHA.108.793273. Epub 2009 Feb 9. PubMed 19204305 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00180258
Lead sponsor
Boston Scientific Corporation
First posted
Sep 16, 2005
Start date
Jan 2000
Completion
Dec 2002
Last update
Jan 25, 2007
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.

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