RISK Stratification Using a Combination of Cardiac Troponin T and Brain Natriuretic Peptide in Patients Receiving CRT-D

Completed

Conditions studied: Heart Failure

In brief

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 patients implanted with cardiac pacemaker-defibrillation devices (CRT-D). Novel biochemical markers identifying patients with high risk cardiac mortality detected by plasma protein analysis will also be evaluated. Hypothesis #1: The combined use of cTnT and BNP at just before implant will predict and risk stratify all cause mortality or HF hospitalization up to 12 months. Hypothesis #2: The change in levels of said biomarkers at different points of follow-up can predict response to CRT through 12 months. Hypothesis #3: The levels of a panel of novel inflammatory mediators, namely chemokines, will be correlated with improvement in 6-minute walk testing, quality of life, and left ventricular ejection fraction in CRT patients.

Key facts

Study ID

NCT00453622

Run by

Abbott Medical Devices

People needed

222

Starts

2005-11-01

Expected to finish

2012-08-01

Last updated by the study team

2019-02-04

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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™

Where it is running

• Veterans' Adminstration Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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