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

This study has been completed.
Sponsor:
Collaborators:
Northwestern University
VA Pittsburgh Healthcare System
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00996086
First received: October 14, 2009
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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 Intervention
Heart Failure
Ventricular Arrhythmias
Device: CRT device implant

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Risk Stratification and Benefits With Cardiac Resynchronization Therapy

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Change in 6-minute hall walk distance between baseline and subsequent follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The occurrence of either death (all-cause) or first HF hospitalization. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cause-specific mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

There is a genetic substudy that will evaluate the presence of certain protein markers.


Enrollment: 154
Study Start Date: February 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CRT device-recipients Device: CRT device implant
CRT device-recipients

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00996086

Locations
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
St. Jude Medical
Northwestern University
VA Pittsburgh Healthcare System
Investigators
Principal Investigator: Alan Kadish, M.D. Northwestern University
Principal Investigator: Alaa Shalaby, M.D. VA Pittsburgh Healthcare System
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00996086     History of Changes
Other Study ID Numbers: CRD 480
Study First Received: October 14, 2009
Last Updated: July 17, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014