CHARM-Preserved
Trial question
What is the role of candesartan in patients with chronic HF and preserved left-ventricular ejection fraction?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 3023
3023 patients (1212 female, 1811 male).
Inclusion criteria: patients with chronic HF and preserved left-ventricular ejection fraction.
Key exclusion criteria: life-threatening adverse event; known bilateral renal artery stenosis; current symptomatic hypotension; persistent systolic or diastolic hypertension; stroke, acute MI, or open heart surgery within the last 4 weeks; or previous heart transplant or heart transplant expected to be performed within the next 6 months.
Interventions
N=1514 candesartan (target dose 32 mg once daily).
N=1509 placebo (matching placebo daily).
Primary outcome
CV death or admission to hospital for CHF
22%
24%
24.0 %
18.0 %
12.0 %
6.0 %
0.0 %
Candesartan
Placebo
Borderline significant
decrease ▼
Borderline significant decrease in CV death or admission to hospital for CHF (22% vs. 24%; aHR 0.86, 95% CI 0.74 to 1).
Secondary outcomes
Significant decrease in nonfatal MI and nonfatal stroke (26% vs. 28%; aHR 0.86, 95% CI 0.75 to 0.99).
Significant decrease in hospital admission for chronic HF (15.9% vs. 18.3%; aHR 0.84, 95% CI 0.7 to 1).
No significant difference in CV death (11.2% vs. 11.3%; aHR 0.95, 95% CI 0.76 to 1.18).
Safety outcomes
Significant difference in drug discontinuation due to adverse event or laboratory abnormality (17.8% vs. 13.5%).
Conclusion
In patients with chronic HF and preserved left-ventricular ejection fraction, candesartan was superior to placebo with respect to CV death or admission to hospital for CHF.
Reference
Yusuf S, Pfeffer MA, Swedberg K et al. Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: the CHARM-Preserved Trial. Lancet. 2003 Sep 6;362(9386):777-81.
Open reference URL