Fluid and Salt Restriction in Decompensated Heart Failure Patients

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Heart Failure

Intervention / Treatment
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* Dietary Supplement: Salt and fluid restriction


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salt and Fluid<br>Intervention: Fluid 800 Ml and Salt 2 g per day Control: FLuid and Salt Free | Dietary Supplement: Salt and fluid restriction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Salt restriction, Fluid restriction, Congestion, Heart Failure