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

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

Tracking Information

• First Submitted Date: October 14, 2009
• First Posted Date: October 16, 2009
• Last Update Posted Date: February 4, 2019
• Study Start Date: February 2010
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 15, 2009)

• Change in 6-minute hall walk distance between baseline and subsequent follow-up [ Time Frame: 12 months ]
• 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 ]
• The occurrence of either death (all-cause) or first HF hospitalization. [ Time Frame: 12 months ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 15, 2009)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)
• Official Title: Risk Stratification and Benefits With Cardiac Resynchronization Therapy
• 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.

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 Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

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

• 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.

Condition

• Heart Failure
• Ventricular Arrhythmias

Intervention

Device: CRT device implant

CRT device-recipients

Study Groups/Cohorts

CRT device-recipients

Intervention: Device: CRT device implant

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 17, 2013): 154
• Original Estimated Enrollment (submitted: October 15, 2009): 150
• Actual Study Completion Date: September 2012
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00996086
• Other Study ID Numbers: CRD 480
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Abbott Medical Devices
• Study Sponsor: Abbott Medical Devices

Collaborators

• 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

• PRS Account: Abbott Medical Devices
• Verification Date: February 2019