User Manual Part 3

B-10
CLINICAL STUDY - COMPANION
INCLUSION/EXCLUSION CRITERIA
The study population consisted of patients with moderate to severe heart
failure, N ew York Heart A ssociation Classification III or IV, left ventricular
ejection fraction ≤ 35%, and QRS width ≥ 120 ms due to ischemic or
non-ischemic cardiomyopathy.
All patients were required to have been treated with a stable dose of
beta-blocker, ACE inhibitor or ARB, diuretic, and aldosterone antagonist. A
stable dose was defined as 30 days for all drugs except beta-blocker, which
required 90 days stabilization from last up titratio n p rio r to rand o mization.
Diuretic dosage could be adjusted any time by the investigator using medical
discretion.
Patients enrolled in the study were required to meet the following inclusion
criteria:
• Moderate or severe heart failure, defined as symptomatic heart failure
for at least six months with NYHA class III or IV symptoms at the time of
enrollment, and at least one of the following events in the previous 12
months:
– Hospitalization for heart failure management
– Outpatient visit in which intravenous (IV) inotropes or vasoactive
infusion were administered continuously for a t least 4 hours
– Emergency room visit of at least twelve hours duration in which IV
heart failure medication s we re administered (including diuretics)
•QRS≥ 120 ms and PR interval > 150 ms from any two leads of a 12–lead
ECG
• Left ventricular ejection fraction ≤ 35%
• Left v entricular end diastolic dime nsion ≥ 60 mm (required only if LVEF
measured by echo) o r > 3.0 cm/m
2
(The cm/m
2
is calculated by LVEDD [in
cm] divided by BSA [body surface area])
•Age≥ 18 years
• Optimal pharmacologic therapy for heart failure (beta blocker, ACE inhibitor,
diuretics, and spironolactone)
- DRAFT -