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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896908
• Other study ID #: HCPA - 120437
• Status: Completed
• Phase: N/A
• First received: July 8, 2013
• Last updated: August 1, 2017
• Start date: March 2013
• Est. completion date: July 31, 2016

Study information

• Verified date: August 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 31, 2016
• Est. primary completion date: July 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Heart Failure

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		seven days or hospital discharge
Secondary	Assessment of clinical stability	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)	Seven days or hospital discharge
Secondary	Neurohormonal activation	Assessment of neurohormonal activation shall include measurement of serum renin, aldosterone, and BNP levels.	On admission and at discharge
Secondary	Daily perception of thirst	A visual scale (with values ranging from 0 to 10) will be used daily to verify the degree of thirst.	Seven days or hospital discharge
Secondary	Readmission rate at 30 days		Patients shall be followed for 30 days after discharge.