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%