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Australia-New Zealand Heart failure Research Collaborative Group Carvedilol Trial - ANZ-Carvedilol
Description:
Carvedilol for LV function and symptoms in stable ischemic heart failure.
Hypothesis:
Carvedilol, a beta blocker with vasodilating effects (alpha blocking properties), would ameliorate heart failure symptoms and decrease heart size.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 442
NYHA Class: I=(30%), II=(54%), III=(6%)
Mean Follow Up: 6 months
Mean Patient Age: 67
Female: 20
Mean Ejection Fraction: 28%
Patient Populations:
Chronic stable heart failure due to ischemic heart disease
Ejection fraction < 45%
NYHA class II-III or previous class II-IV
Exclusions:
NYHA class IV
Heart rate < 50 beats per minutes
Sick sinus syndrome
Second or third degree heart block
Blood pressure < 90 mm Hg systolic
Blood pressure > 160/100 mm Hg
Treadmill exercise duration < 2 minutes or > 18 minutes
Recent coronary event
Unstable angina, CABG, PTCA within four weeks of trial entry
Primary Endpoints:
Symptoms of heart failure and use of angina drugs
Secondary Endpoints:
Combinations of primary endpoints
Drug/Procedures Used:
Carvedilol 3.125mg administered initially and progressively escalated to a target dose of 25mg bid.
Concomitant Medications:
Not explicitly stated
Principal Findings:
At 12 months, LVEF increased by 5.2% (p < 0.0001) in patients receiving carvedilol (n=207) compared to placebo (n=208). The left ventricular end-diastolic volume index was 14 ml/m2 less in the carvedilol than in the placebo group (p = 0.0015); and the left ventricular end-systolic volume index was 15.3 ml/m2 less (p = 0.0001).
At 12 months, there was no significant change in treadmill exercise duration, six minute walk distance, NYHA class, or SAS score.
At 19 months, there was a significant reduction in composite death or hospitalization for the carvedilol group (50%) versus placebo (63%), a relative risk reduction of 21% (95% CI, 6% to 34%). Rates of hospitalization were also significantly lower for patients treated with carvedilol (48%) compared to placebo (58%), an 18% relative risk reduction (95% CI, 1% to 32%).
Interpretation:
The beneficial effects of carvedilol on left-ventricular function and size were maintained for at least a year after the start of treatment, but carvedilol had no effect on exercise performance, symptoms, or episodes of worsening heart failure. There was an overall reduction in events resulting in death or hospital admission, and a year of treatment with carvedilol resulted in the avoidance of one such serious event among every 12-13 (SE 5) of these patients with chronic stable heart failure. The role of beta blockers in chronic heart failure continues to evolve as encouraging data accumulates.
References:
1. Circulation 1995;92:212-218 Design and baseline results
2. Lancet 1997;349:375-80 Final results
3. J Am Coll Cardiol 1997; 29:1060-6 2-D Echo substudy
Keywords: Carbazoles, Ventricular Function, Left, Heart Failure, Coronary Disease, Stroke Volume, Propanolamines, Hospitalization
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