Abstract
BackgroundAlthough half of all patients with heart failure (HF) have a normal or near-normal ejection fraction and their prognosis differs little from that of patients with a reduced ejection fraction, the pathophysiology of HF with preserved ejection fraction (HF-PEF) is still poorly understood, and its management poorly supported by clinical trials. Sodium and fluid restriction is the most common self-care measure prescribed to HF patients for management of congestive episodes. However, its role in the treatment of HF-PEF remains unclear. This trial seeks to compare the effects of a sodium- and fluid-restricted diet versus an unrestricted diet on weight loss, neurohormonal activation, and clinical stability in patients admitted for decompensated HF-PEF.Methods/DesignThis is a randomized, parallel trial with blinded outcome assessment. The sample will include adult patients (aged ≥18 years) with a diagnosis of HF-PEF admitted for HF decompensation. The patients will be randomized to receive a diet with sodium and fluid intake restricted to 0.8 g/day and 800 mL/day respectively (intervention group) or an unrestricted diet, with 4 g/day sodium and unlimited fluid intake (control group), and followed for 7 days or until hospital discharge. The primary outcome shall consist of weight loss at 7 days or discharge. The secondary outcome includes assessment of clinical stability, neurohormonal activation, daily perception of thirst and readmission rate at 30 days.DiscussionAssessment of the effects of sodium and fluid restriction on neurohormonal activation and clinical course of HF-PEF can promote a deeper understanding of the pathophysiology and progression of this complex syndrome.Trial registration numberClinicalTrials.gov identifier: NCT01896908 (date of registration: 8 August 2013).
Highlights
Half of all patients with heart failure (HF) have a normal or near-normal ejection fraction and their prognosis differs little from that of patients with a reduced ejection fraction, the pathophysiology of HF with preserved ejection fraction (HF-PEF) is still poorly understood, and its management poorly supported by clinical trials
Assessment of the effects of sodium and fluid restriction on neurohormonal activation and clinical course of HF-PEF can promote a deeper understanding of the pathophysiology and progression of this complex syndrome
Heart failure (HF) with preserved ejection fraction (HFPEF), historically known as diastolic HF, is the clinical syndrome characterized by HF with normal or near-normal systolic function [1]
Summary
Patients will receive the standard hospital diet for both the control (normal diet) and intervention group (low-sodium diet), modified only in the amount of fluid offered to the intervention group. Patients will be instructed to consume only foods and beverages offered by the hospital. The plate-waste method shall be used to measure sodium intake for 7 days or until hospital discharge, whichever comes first. Thirteen patients have completed the study protocol and additional patients are being recruited. Authors’ contributions KSMD, MMT, SLSB and JVM will conduct the data collection. KSMD, ERRS, GCS, AB, LEPR, NC and LBS conceived the study and drafted this manuscript. KSMD, ERRS, GCS and LBS will participate in the data analysis. All authors read and approved the final manuscript
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