Status:
COMPLETED
RISK Stratification Using a Combination of Cardiac Troponin T and Brain Natriuretic Peptide in Patients Receiving CRT-D
Lead Sponsor:
Abbott Medical Devices
Collaborating Sponsors:
VA Pittsburgh Healthcare System
Conditions:
Heart Failure
Eligibility:
All Genders
18-90 years
Brief Summary
The purpose of the study is to identify if the combined use of cardiac troponin enzyme (cTnT) and brain natriuretic peptide (BNP) can predict Heart Failure (HF)improvement and all-cause mortality in p...
Detailed Description
Primary Endpoint The primary endpoint is the occurrence of either death or first HF hospitalization. HF hospitalizations must satisfy both of the following criteria: 1. Admission to hospital for \>2...
Eligibility Criteria
Inclusion
- Referred for implantation of CRT-D according to currently accepted guidelines.
- 18 years or older
- Ability to independently comprehend and complete a QOL questionnaire
- Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up
- Has stable conventional medications at least one month prior to enrollment
Exclusion
- Inability to successfully implant an intravascular lead CRT-D device. (i.e. exclude epicardial leads)
- Myocardial infarction or unstable angina in the last 3 weeks
- Chronic atrial fibrillation (continuous AF lasting \> 1 Month) within 1 year prior to enrollment or having undergone cardioversion for AF in the past month
- Status 1 classification for cardiac transplantation
- Currently participating in a clinical trial that includes an active treatment arm
- Life expectancy of less than 6 months.
- Recent (within 24 hours) administration of Nesiritide™
Key Trial Info
Start Date :
November 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT00453622
Start Date
November 1 2005
End Date
August 1 2012
Last Update
February 4 2019
Active Locations (1)
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1
Veterans' Adminstration Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240