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Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT) (BENEFIT)

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ClinicalTrials.gov Identifier: NCT00996086
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
Northwestern University
VA Pittsburgh Healthcare System
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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Brief Summary:
This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients.

Condition or disease Intervention/treatment
Heart Failure Ventricular Arrhythmias Device: CRT device implant

Detailed Description:

The purpose of the study is two-fold. First, to determine if an algorithm can be developed based on pre-implant clinical variables to predict response to CRT-D therapy. Second, the study aims to determine in patients implanted with CRT-D if the combined use of cTnT and BNP can further predict and risk-stratify HF improvement and all-cause mortality. Additionally, novel biochemical markers defining cardiac mortality in high risk patients detected by plasma proteomic analysis in the CRT-D patients will be evaluated.

This study represents a combination of previous CRT studies that evaluated these variables independently. Data from this study will be pooled with data from previous studies to build a more complete picture of CRT therapy.

Study Design
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Study Type : Observational
Actual Enrollment : 154 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Risk Stratification and Benefits With Cardiac Resynchronization Therapy
Study Start Date : February 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012
Groups and Cohorts
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Group/Cohort Intervention/treatment
CRT device-recipients Device: CRT device implant
CRT device-recipients


Outcome Measures
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Primary Outcome Measures :
  1. Change in 6-minute hall walk distance between baseline and subsequent follow-up [ Time Frame: 12 months ]
  2. Composite endpoint a. 6-minute hall walk distance b. NYHA Classification c. Quality of Life (Minnesota Living with Heart Failure, DASS, SF-36) [ Time Frame: 12 months ]
  3. The occurrence of either death (all-cause) or first HF hospitalization. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 12 months ]
  2. Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index [ Time Frame: 12 months ]
  3. Cause-specific mortality [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
There is a genetic substudy that will evaluate the presence of certain protein markers.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who undergo implantation of a market-approved St. Jude Medical CRT defibrillator (CRT-D) and a compatible lead system may be included in the study.
Criteria

Inclusion Criteria:

  • Meets current clinical indications for CRT-D therapy
  • Patient is 18 years old or older
  • Ability to independently comprehend and complete all QOL questionnaires
  • Patient has the ability to perform the 6-minute Hall Walk Test (6-MHW) with the only limiting factor being fatigue or shortness-of-breath
  • Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up

Exclusion Criteria:

  • Inability to successfully implant an intravascular lead and CRT-D device. (i.e. exclude epicardial leads) within 30 days of initial procedure.
  • Myocardial infarction in the last 3 weeks
  • Unstable angina in the last 3 weeks
  • Status 1 classification for cardiac transplantation
  • Currently participating in a clinical trial that includes an active treatment arm
  • Life expectancy of less than 12 months.
  • Recent (within 1 week) administration of Nesiritide™ or inotropes
  • Patients in whom revascularization is expected
  • Patient is pregnant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996086


Locations
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United States, New York
Touro College
New York, New York, United States, 10010
United States, Pennsylvania
Veterans' Adminstration Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
Abbott Medical Devices
Northwestern University
VA Pittsburgh Healthcare System
Investigators
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Principal Investigator: Alan Kadish, M.D. Northwestern University
Principal Investigator: Alaa Shalaby, M.D. VA Pittsburgh Healthcare System
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00996086    
Other Study ID Numbers: CRD 480
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases