Effect of Dietary Sodium Restriction in the Management of Patients With Heart Failure and Diastolic Dysfunction

Diastolic Dysfunction Clinical Trial

Official title: Effect of Dietary Sodium Restriction in the Management of Patients With Heart Failure and Preserved Ejection Fraction: a Randomized Clinical Trial

Status Completed

Clinical Trial Summary

Although half of the patients with HF has normal ejection fraction or slightly altered (HF-PEF) and the prognosis differs little from those with reduced ejection fraction, the pathophysiology of HF-PEF is still poorly understood.

Sodium restriction is the most common measure of self-care oriented to HF patients for management of congestive episodes. The role of this orientation in the treatment of patients with preserved ejection fraction, however, is still unclear. The evaluation of the effects of sodium restriction on neurohormonal activation and episodes of decompensation in HF-PEF can promote a better understanding of the pathophysiological progression of this complex syndrome.

Clinical Trial Description

This 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. ;

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Heart Failure

• NCT number: NCT01896908
• Study type: Interventional
• Source: Hospital de Clinicas de Porto Alegre
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Completion date: July 31, 2016