What is the clinical evidence from this study?

Study design: RCT. Population: chronic heart failure (CHF) (n=7599). Intervention: candesartan vs. placebo. Primary outcome: improvement in NYHA functional class at the end of the study compared to baseline (LVCF analysis) (p=0.003).

November 1, 2004Open Access

Effect of candesartan on New York Heart Association functional classResults of the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) programme

Key Result

Candesartan improved NYHA functional class compared to placebo in patients with chronic heart failure (35.4% vs 32.5% improved; p=0.003).

Study Design

Type

RCT (n=7,599)

Randomization

randomized

Multicenter

Yes

Structured PICO

Does candesartan improve NYHA functional class in patients with symptomatic chronic heart failure?

Population

7,599 patients with symptomatic chronic heart failure (CHF)

Intervention

Candesartan added to other proven treatments for CHF

Comparator

Placebo added to other proven treatments for CHF

Outcome

Change in NYHA functional class (classified as better, unchanged, or worse at the end of the study compared to baseline)patient reported

Candesartan significantly improves NYHA functional class compared to placebo in patients with symptomatic chronic heart failure.

Main Result

Absolute Event Rate: 35.4% vs 32.5%

p-value: p=0.003

Abstract

AIMS: To evaluate the effect of the angiotensin receptor blocker candesartan on New York Heart Association (NYHA) functional class in a broad spectrum of patients with chronic heart failure (CHF). METHODS AND RESULTS: Patients in the CHARM Programme with symptomatic CHF were randomized to placebo (n=3796) or candesartan (n=3803) and followed for a median of 38 months. NYHA class was assessed at baseline, at two weekly intervals during dose titration and 4 monthly thereafter. Patients were classified as "better", "unchanged" or "worse" at the end of the study compared to baseline. Both a simple "last visit carried forward" (LVCF) analysis and "worst rank carried forward" (WRCF) analysis (where patients who died were allocated NYHA class V) were used. In the LVCF analysis, compared to placebo, more candesartan patients improved (35.4% versus 32.5%) and fewer worsened (9.0% versus 10.3%) in NYHA class (p=0.003). The WRCF analysis also showed a better overall change in NYHA class with candesartan compared to placebo. There was no heterogeneity in the response to candesartan between the CHARM component trials. CONCLUSIONS: Candesartan improves NYHA functional class to a similar extent to other proven treatments for CHF when added to these other treatments.