Clinical trial NCT01896908: Effect of Dietary Sodium Restriction in the Management of Patients With Heart Failure and Diastolic Dysfunction
Official title: Effect of Dietary Sodium Restriction in the Management of Patients With Heart Failure and Preserved Ejection Fraction: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diastolic Dysfunction
Keywords: diastolic dysfunction
Sodium restriction
Randomized clinical trial
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Weight loss
timeFrame: seven days or hospital discharge
Secondary outcomes:
measure: Assessment of clinical stability
timeFrame: Seven days or hospital discharge
measure: Neurohormonal activation
timeFrame: On admission and at discharge
measure: Daily perception of thirst
timeFrame: Seven days or hospital discharge
measure: Readmission rate at 30 days
timeFrame: Patients shall be followed for 30 days after discharge.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
Study officials:
affiliation: HCPA
name: Eneida Rabelo da Silva, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.