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OpenTrials
Completed

NCT Number: NCT01133236

Fluid and Salt Restriction in Decompensated Heart Failure Patients

The non-pharmacological measures that are widely practiced and recommended for HF patients, such as salt and water restriction, specially at moments of disease decompensation, still lack clearer evidence of their therapeutic effect.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Heart Failure Clinics, healthcare structures formed by a multidisciplinary team specialized in the disease, have demonstrated to provide benefits to patients through multiple non-pharmacological interventions, among them fluid and salt restriction. Sodium restriction has a class I recommendation and evidence level C, that is, general agreement that the intervention is beneficial, useful and effective, evidenced by consensus, expert opinion, small studies, retrospective studies or registries. Sodium restriction becomes even more controversial when we consider evidence suggesting the benefit of non-salt restriction or treatments with salt administration, in the form of hypertonic solutions. In face of literature evidence not showing conclusive results about the benefit of sodium and fluid restriction, we designed this study in order to assess the effect of fluid and salt restriction on the management of patients hospitalized due to decompensated heart failure

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of both sexes, with age equal to or above 18 years, diagnosed with decompensated HR (systolic dysfunction), according to the Boston Criteria (score > 8 points), who agree to participate in the study and sign an informed consent form.

Exclusion criteria

  • Patients presenting with endogenous creatinine clearance (ECC) values lower than or equal to 50-60 mL/min (obtained by the Cockcroft-Gault equation) at hospital admission, cardiogenic shock, survival compromised by another evolving disease, those with difficulty complying with treatment (dementia, cognitive deficit).

Treatment and study plan

Salt and fluid restriction

Dietary Supplement

I: Intervention Prescription of low-sodium diet with additional 2 g of sodium and water restriction to 800 mL/day.

II: Control Prescription without sodium and fluid restriction.

Primary outcomes

  1. Bodyweight loss

    Time frame: 7 days

    Daily weight on a digital scale

  2. Clinical stability

    Time frame: Seven days.

    Clinical assessment daily for 7 days.

Secondary outcomes

  1. Health state evaluation.

    Time frame: 30 days

    Evaluation of health state using the Euro-QOL 5D for 30 days after the 7th day of clinical stability assessment.

  2. Evaluation of thirst sensation.

    Time frame: Seven days

    Evaluation of thirst score on the Thirst Scale, daily for seven days.

  3. Re-hospitalizations.

    Time frame: 30 days

    Medical records assessed for 30 days after the 7th day of clinical stability assessment.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

Randomized Clinical Trial to Assess the Effect of Fluid and Salt Restriction on the Management of Patients Hospitalized Due to Decompensated Heart Failure

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 28, 2010
Registry last updated
Jan 3, 2014

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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