Prospective assessing metabolic abnormalities, lifestyle and dietary pattern in a Chinese population with heart failure: the MALD-HF study protocol.

INTRODUCTION

The evidence on predictive value of lifestyle behaviours and dietary pattern on the prognosis of heart failure (HF) is limited. Our aim is to identify these factors in the setting of secondary prevention of HF.

METHODS AND ANALYSIS

The Metabolic Abnormalities, Lifestyle and Dietary Pattern in Heart Failure study is an ongoing, prospective cohort, single-centre study that aims to recruit 1500 patients with HF from June 2016 to June 2021. At baseline, each participant completes a questionnaire on demographic characteristics, medical history, lifestyle behaviours, sleep duration and quality, bowel movements and regular diet. Biochemical measurements, blood pressure, carotid ultrasound, echocardiography, electrocardiography and cardiac magnetic resonance are obtained and analysed. Muscle strength is assessed using the handgrip dynamometer and the MicroFet2 hand-held dynamometer. Each patient is followed for 5 years or until the occurrence of death. The primary outcome is a composite of cardiovascular mortality or hospitalisation due to worsening heart failure. The secondary end points are cardiovascular deaths and the hospitalisations due to worsening HF. The incidence of mortality and cardiovascular events is documented biennially.

ETHICS AND DISSEMINATION

The study protocol has been approved by the Ethics Committee of the Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and follows the norms of the World's Association Declaration of Helsinki. The results of this study will be disseminated in peer-reviewed journals and academic conferences.

TRIAL REGISTRATION NUMBER

NCT03951311.