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

Not Applicable

Completed

• Conditions: Diastolic Dysfunction
• Interventions: Other: Sodium restriction

• Registration Number: NCT01896908
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-08
• Study First Posted: 2013-07-11
• Primary Completion: 2016-07-31
• Study Completion: 2016-07-31
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Patients of both sexes
• Age equal to or above 18 years
• Diagnosis of heart failure whit preserved ejection fraction (LVEF> 50%)
• Patients hospitalized for heart failure decompensation whit hospital admission within 36 hours, who agree to participate in the study by signing the informed consent.

Exclusion Criteria

• Patients who present values of endogenous creatinine clearance less than or equal to 30 ml / min;
• Cardiogenic shock,
• Those with survival compromised by another disease in evolution and / or difficulty adhering to treatment (dementia, cognitive impairment)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Sodium restriction	Sodium restriction (1.6g sodium daily - 4g salt) combined with 800 ml of fluid intake

Primary Outcome Measures

Name	Time	Method
Weight loss	seven days or hospital discharge

Secondary Outcome Measures

Name	Time	Method
Assessment of clinical stability	Seven days or hospital discharge	Symptomatic improvement without evidence of congestion (congestion score); Weight stable for two days, without changing more than 1kg, (daily weight); Without IV drug for HF for 48 hours (daily record of medication: diuretics, vasodilators); No increase in diuretic dose for 48 hours (daily records of medications)
Daily perception of thirst	Seven days or hospital discharge	A visual scale (with values ranging from 0 to 10) will be used daily to verify the degree of thirst.
Neurohormonal activation	On admission and at discharge	Assessment of neurohormonal activation shall include measurement of serum renin, aldosterone, and BNP levels.
Readmission rate at 30 days	Patients shall be followed for 30 days after discharge.

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil