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

Primary Endpoint

The primary endpoint is the occurrence of either death or first HF hospitalization. HF hospitalizations must satisfy both of the following criteria:

• Admission to hospital for >24 hours with at least one of the following HF worsening symptoms:

• Increased CHF class
• Orthopnea
• Paroxysmal nocturnal dyspnea
• Edema
• Dyspnea on exertion, or
• Gastrointestinal (GI) symptoms attributable to HF
• Placement on the Status I heart transplant list

AND

• One or more of the following intensive treatment(s) for HF within 24 hours of admission:

• Intravenous (IV) diuresis
• IV inotropic medications prescribed during the hospitalization, or
• Increasing frequency of dialysis for patients with chronic renal failure

2.3 Secondary Endpoints

Secondary endpoints include:

• Cause of death
• Change in NYHA functional class
• Number of HF related hospitalizations
• Performance on a standard 6-minute hall walk test
• Quality of Life as measured by the Minnesota Living with Heart Failure (MLWHFQ) questionnaire
• Patient global clinical assessment
• Left ventricular ejection fraction (LVEF) measured by echocardiography
• LV volume measured by echocardiography
• LV lead placement position
• QRS duration at baseline and with CRT
• Number of AT/AF, VT/VF episodes
• Frequency of appropriate/inappropriate ICD therapy
• % Atrial and Ventricular Pacing
• Antiarrhythmic drug utilization
• Study related complications

2.3.1 Response to CRT

• A positive response to CRT is defined by the following: Improvement in NYHA functional class by at least one grade
• Improvement in echocardiographic LVEF & left ventricular end diastolic index (LVEDI)
• Improvement in patient global clinical assessment
• Improvement in 6-minute hall walk by 10%

Inclusion criteria

• 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 criteria

• 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™