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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Clinical Trial to Assess the Effect of Fluid and Salt Restriction on the Management of Patients Hospitalized Due to Decompensated Heart Failure|
- Bodyweight loss [ Time Frame: 7 days ] [ Designated as safety issue: No ]Daily weight on a digital scale
- Clinical stability [ Time Frame: Seven days. ] [ Designated as safety issue: No ]Clinical assessment daily for 7 days.
- Health state evaluation. [ Time Frame: 30 days ] [ Designated as safety issue: No ]Evaluation of health state using the Euro-QOL 5D for 30 days after the 7th day of clinical stability assessment.
- Evaluation of thirst sensation. [ Time Frame: Seven days ] [ Designated as safety issue: No ]Evaluation of thirst score on the Thirst Scale, daily for seven days.
- Re-hospitalizations. [ Time Frame: 30 days ] [ Designated as safety issue: No ]Medical records assessed for 30 days after the 7th day of clinical stability assessment.
|Study Start Date:||August 2009|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Salt and Fluid
Intervention: Fluid 800 Ml and Salt 2 g per day Control: FLuid and Salt Free
Dietary Supplement: Salt 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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133236
|Principal Investigator:||Luis B Silva-Neto, MD, ScD||Post Graduated Program of Federal University Program|