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CHARM TRIAL |
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| Problem | Heart failure (EF < 40%; Stage II or IV) |
| Format | Double-blinded multi-center RCT |
| Treatment | Candesartan +- ACEi |
| Control | Placebo |
| Population | 4576 patients |
| Inclusion criteria | Adult patients (≥18 years) with symptomatic CHF (NYHA class II through IV) for at least 4 weeks were eligible for the CHARM-Alternative and CHARM-Added trials. The CHARM-Added trial required patients to take an ACE inhibitor. If investigators observed that an ACE inhibitor was not tolerated, then patients could be entered into the CHARM-Alternative trial. The ejection fraction must have been â‰_40% and determined within 6 months of trial entry. Patients in CHARM-Added who were in NYHA class II had the additional requirement of a hospitalization for a cardiac-related reason in the previous 6 months. |
| Exclusion criteria | Creatinine >265umol/L (>3mg/dL) Potassium >5.5mmol/L Bilateral renal artery stenosis Symptomatic hypotension ARB given within 2 weeks |
| Follow-up | Median 33.7 - 41 |
| Primary endpoint | Cardiovascular death or CHF hospitalization for sub trials All-cause mortality for combined trial |
| Secondary endpoint(s) | Cardiovascular death, admission to hospital for CHF, or non-fatal myocardial infarction; cardiovascular death, admission to hospital for CHF, non-fatal myocardial infarction, or non-fatal stroke; cardiovascular death, admission to hospital for CHF, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularisation; death (any cause) or admission to hospital for CHF; and development of new diabetes. |
| Details | - |
| Brief summary: | ARBs reduced death in CCF; may add to ACEi benefit (N.B. Val-HF); no benefit in preserved LV dysfunction |
| PAPER: Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function taking angiotensin-converting-enzyme inhibitors: the CHARM-Added trial. | |
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| Date | 6 Sep 2003 |
| Journal | Lancet. 2003 Sep 6;362(9386):767-71. |
| Information | CHARM-Added sub-trial (EF < 40% on ACEi) -Candesartan reduced combined CV death and HF hospitalisation (N.B. See caution from Val-HF trial) |
| PAPER: Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function intolerant to angiotensin-converting-enzyme inhibitors: the CHARM-Alternative trial. | |
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| Date | 6 Sep 2003 |
| Journal | Lancet. 2003 Sep 6;362(9386):772-6. |
| Information | CHARM-Alternative sub-trial (EF <40% intolerant of ACEi) -Cendesartan reduced combined CV death and HF hospitalisation |
| PAPER: Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: the CHARM-Preserved Trial | |
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| Date | 6 Sep 2003 |
| Journal | Lancet. 2003 Sep 6;362(9386):777-81. |
| Information | CHARM-Preserved sub-trial (HF, EF > 40%) -Non-significant reduction in combined CV death and HF hospitalisation |
| PAPER: Mortality and morbidity reduction with Candesartan in patients with chronic heart failure and left ventricular systolic dysfunction: results of the CHARM low-left ventricular ejection fraction trials. | |
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| Date | 26 Oct 2004 |
| Journal | Circulation. 2004 Oct 26;110(17):2618-26. Epub 2004 Oct 18. |
| Information | Combined CHARM-Added/Alternative -Candesartan added to standard therapy reduced: -All-cause mortality -CV death -CCF hospitalisations |
| PAPER: Relationship of dose of background angiotensin-converting enzyme inhibitor to the benefits of candesartan in the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity | |
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| Date | 15 May 2006 |
| Journal | Am Heart J. 2006 May;151(5):985-91. |
| Information | Analysis of CHARM-Added trial -Addition of Candesartan to ACEi benefits regardless of ACEi dose or drug |