Eligibility criteria in heart failure randomized controlled trials: a gap between evidence and clinical practice

Costantino, Giorgio; Rusconi, Anna Maria; Duca, Piergiorgio; Guzzetti, Stefano; Bossi, Ilaria; Medico, Marta Del; Pisano, Giuseppina; Bulgheroni, Mara; Solbiati, Monica; Furlan, Raffaello; Montano, Nicola

doi:10.1007/s11739-008-0180-9

Cited by 24 publications

(24 citation statements)

References 27 publications

(27 reference statements)

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“…In particular there was a strong male gender prevalence (77.3% in eplerenone and 78.1% in placebo groups) and median age of about 69 years. In daily practice heart failure epidemiology is different, with older patients and more common in female gender [7].…”

Section: Discussionmentioning

confidence: 99%

Eplerenone, an aldosterone antagonist, reduces hospitalization and death in heart failure patients with nyha class II and an ejection fraction of less than 30%

2011

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Section: Discussionmentioning

confidence: 99%

Eplerenone, an aldosterone antagonist, reduces hospitalization and death in heart failure patients with nyha class II and an ejection fraction of less than 30%

2011

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“…In daily practice, heart failure epidemiology is different; with older patients and female gender more represented [6].…”

Section: Weakness Of the Studymentioning

confidence: 99%

Ivabradine added to guidelines-based therapy in systolic heart failure patients

Rusconi

Ceriani²,

Metodologica

2011

Intern Emerg Med

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confidence: 93%

Heart failure and clinical practice

et al. 2009

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The interesting letter by Bruno Trimarco and Alessandro Bellis regarding our study [1] opens two complex questions. First, the capacity of a randomized clinical trial (RCT) to represent the real world, and, when it does, what is the possibility of obtaining reliable results? This produces a need for a delicate balance. If the selection of patients in a RCT study is tight, less ''confounders'' can influence the results, but the results can be applicable to only a limited number of patients. A theoretical solution for this first point is, in our opinion, impossible. In our study [1] we tried only to highlight that in most of the major heart failure RCT studies, published in prior years, a tight selection of a particular type of patients (relatively young, male, without comorbidities, etc.) has been often the chosen study group. This selection reduces the capacity of these studies to represent our general population of patients with heart failure. We completely agree with Trimarco and Bellis that: ''the guidelines for management of heart failure (resulting from RCT results) should be interpreted rather than strictly followed''. Nevertheless, if the results were obtained from a selected population of patients with heart failure, we do not have reliable indications for many other patients (old, female; with comorbidities, etc.), in particular for treatment choices. Treating patients on the basis of ''pathophysiological observations'', without consistent results from RCT studies, is considered a ''second-choice'' practice by many clinicians.The other point raised by Trimarco and Bellis [2] concerns the observation that mortality in heart failure trials is reduced only for a brief follow-up period (no more than 5 years), whereas when longer observational periods are considered, treatment efficacy is progressively reduced.In this regard we would like to emphasize that heart failure prognosis is ominous. The 1-year mortality is more than 20% [3], while the 5-year mortality more than 70% [3]. Stewart and colleagues [3] compare heart failure prognosis with breast, bowel, lung and ovarian cancers and they observe that only lung cancer prognosis is worse than that of heart failure. We think that clinical trials with a less selected population, and with a 2-3 years period of followup could be more similar to everyday clinical practice, and could offer an answer to the real efficacy of heart failure therapy. Because of the ominous prognosis connected to heart failure, a longer follow-up could mask treatments effects without giving more informative results.

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Eligibility criteria in heart failure randomized controlled trials: a gap between evidence and clinical practice

Cited by 24 publications

References 27 publications

Eplerenone, an aldosterone antagonist, reduces hospitalization and death in heart failure patients with nyha class II and an ejection fraction of less than 30%

Eplerenone, an aldosterone antagonist, reduces hospitalization and death in heart failure patients with nyha class II and an ejection fraction of less than 30%

Ivabradine added to guidelines-based therapy in systolic heart failure patients

Heart failure and clinical practice

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