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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salt and Fluid | Experimental | Intervention: Fluid 800 Ml and Salt 2 g per day Control: FLuid and Salt Free |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bodyweight loss | Daily weight on a digital scale | 7 days |
| Clinical stability | Clinical assessment daily for 7 days. | Seven days. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis B Silva-Neto, MD, ScD | Post Graduated Program of Federal University Program | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23689381 | Derived | Aliti GB, Rabelo ER, Clausell N, Rohde LE, Biolo A, Beck-da-Silva L. Aggressive fluid and sodium restriction in acute decompensated heart failure: a randomized clinical trial. JAMA Intern Med. 2013 Jun 24;173(12):1058-64. doi: 10.1001/jamainternmed.2013.552. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012492 | Salts |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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| Seven days |
| Re-hospitalizations. | Medical records assessed for 30 days after the 7th day of clinical stability assessment. | 30 days |