Fluid and Salt Restriction in Decompensated Heart Failure Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01133236

Enrollment

Registered

2010-05-28

Start date

2009-08-31

Completion date

2012-09-30

Last updated

2014-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Salt restriction, Fluid restriction, Congestion, Heart Failure

Brief summary

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.

Detailed description

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

Interventions

DIETARY_SUPPLEMENTSalt and fluid restriction

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Bodyweight loss	7 days	Daily weight on a digital scale
Clinical stability	Seven days.	Clinical assessment daily for 7 days.

Secondary

Measure	Time frame	Description
Health state evaluation.	30 days	Evaluation of health state using the Euro-QOL 5D for 30 days after the 7th day of clinical stability assessment.
Evaluation of thirst sensation.	Seven days	Evaluation of thirst score on the Thirst Scale, daily for seven days.
Re-hospitalizations.	30 days	Medical records assessed for 30 days after the 7th day of clinical stability assessment.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026