Justification and design of the BOCADOS-IC study: Nutritional management in adults followed in Spanish hospitals for heart failure

Abstract

Introduction and objectives

Malnutrition is common in patients with heart failure (HF) and is associated with increased mortality and hospital admissions. There is evidence that nutritional intervention in the inpatient setting improves the prognosis, but evidence in the outpatient setting is limited. This study aims to assess whether a nutritional intervention in outpatients with HF and malnutrition produces a benefit in their morbidity and mortality.

Methods

BOCADOS-IC (Nutritional Assessment in Adults followed in Spanish hospitals for Heart Failure) is a randomised, controlled, masked, prospective, multicentre, clinical trial that includes patients with HF followed on an outpatient basis and who present malnutrition by the screening Mini Nutritional Assessment-Short Form (MNA-SF) scale. Patients are randomised to a control group (standard follow-up) or the intervention group (multifactorial nutritional intervention). A sample size of 266 patients has been estimated, with a follow-up of 6 months. The primary endpoint is time to death from any cause or admission for HF. The analysis is performed on an intention-to-treat basis.

Conclusions

The BOCADOS-IC trial aims to evaluate the impact of nutritional intervention in malnourished patients with HF in the outpatient setting.