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

NCT ID: NCT01896908

Last Updated: 2017-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-07-31

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.

Conditions

Diastolic Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Sodium restriction

Intervention Type: OTHER

Patients that are eligible and fulfill the inclusion criteria will be invited to participate while hospitalized, and then sign the informed consent form. Then, the dietitian on call will be notified in order to change the dietary map of the patients. The prescription diet for both the intervention and control group will be the same: DIET AS RESEARCH PROTOCOL. PATIENT WILL RECEIVE THE DIET UNTIL DAY __ / __ OR DISCHARGE. PLEASE DO NOT CHANGE IT. This will be combined with the medical staff and with the Nutrition and Dietetics service.

The evaluation of outcomes after hospital discharge will be held in the institution of reference when will be performed clinical evaluation and blood samples collection for neurohormonal activation analysis.

Control

Normal sodium diet (4g sodium daily - 10g salt) and free fluid intake

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sodium restriction

Patients that are eligible and fulfill the inclusion criteria will be invited to participate while hospitalized, and then sign the informed consent form. Then, the dietitian on call will be notified in order to change the dietary map of the patients. The prescription diet for both the intervention and control group will be the same: DIET AS RESEARCH PROTOCOL. PATIENT WILL RECEIVE THE DIET UNTIL DAY __ / __ OR DISCHARGE. PLEASE DO NOT CHANGE IT. This will be combined with the medical staff and with the Nutrition and Dietetics service.

The evaluation of outcomes after hospital discharge will be held in the institution of reference when will be performed clinical evaluation and blood samples collection for neurohormonal activation analysis.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eneida Rabelo da Silva, ScD

Role: PRINCIPAL_INVESTIGATOR

HCPA

Locations

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

Machado d'Almeida KS, Rabelo-Silva ER, Souza GC, Trojahn MM, Santin Barilli SL, Aliti G, Rohde LE, Biolo A, Beck-da-Silva L. Aggressive fluid and sodium restriction in decompensated heart failure with preserved ejection fraction: Results from a randomized clinical trial. Nutrition. 2018 Oct;54:111-117. doi: 10.1016/j.nut.2018.02.007. Epub 2018 Mar 21.

Reference Type: DERIVED

PMID: 29793053 (View on PubMed)

d'Almeida KS, Rabelo-Silva ER, Souza GC, Trojahn MM, Barilli SL, Mansson JV, Biolo A, Rohde LE, Clausell N, Beck-da-Silva L. Effect of fluid and dietary sodium restriction in the management of patients with heart failure and preserved ejection fraction: study protocol for a randomized controlled trial. Trials. 2014 Sep 4;15:347. doi: 10.1186/1745-6215-15-347.

Reference Type: DERIVED

PMID: 25187436 (View on PubMed)

Other Identifiers

HCPA - 120437

Identifier Type: -

Identifier Source: org_study_id