Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT) (BENEFIT)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Risk Stratification and Benefits With Cardiac Resynchronization Therapy|
- 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 ]
- 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.
|Study Start Date:||February 2010|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Device: CRT device implant
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996086
|United States, New York|
|New York, New York, United States, 10010|
|United States, Pennsylvania|
|Veterans' Adminstration Pittsburgh Healthcare System|
|Pittsburgh, Pennsylvania, United States, 15240|
|Principal Investigator:||Alan Kadish, M.D.||Northwestern University|
|Principal Investigator:||Alaa Shalaby, M.D.||VA Pittsburgh Healthcare System|