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NCT Number: NCT01896908

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

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.

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Key information

Conditions

Diastolic Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sodium restriction

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.

Primary outcomes

  1. Weight loss

    Time frame: seven days or hospital discharge

Secondary outcomes

  1. Assessment of clinical stability

    Time frame: 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)

  2. Neurohormonal activation

    Time frame: On admission and at discharge

    Assessment of neurohormonal activation shall include measurement of serum renin, aldosterone, and BNP levels.

  3. Daily perception of thirst

    Time frame: 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.

  4. Readmission rate at 30 days

    Time frame: Patients shall be followed for 30 days after discharge.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2013
Registry last updated
Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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