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Fluid and Salt Restriction in Decompensated Heart Failure Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01133236
First Posted: May 28, 2010
Last Update Posted: January 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eneida Rejane Rabelo da Silva, Hospital de Clinicas de Porto Alegre
  Purpose
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.

Condition Intervention
Heart Failure Dietary Supplement: Salt and fluid restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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

Resource links provided by NLM:


Further study details as provided by Eneida Rejane Rabelo da Silva, Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Bodyweight loss [ Time Frame: 7 days ]
    Daily weight on a digital scale

  • Clinical stability [ Time Frame: Seven days. ]
    Clinical assessment daily for 7 days.


Secondary Outcome Measures:
  • 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.

  • Evaluation of thirst sensation. [ Time Frame: Seven days ]
    Evaluation of thirst score on the Thirst Scale, daily for seven days.

  • Re-hospitalizations. [ Time Frame: 30 days ]
    Medical records assessed for 30 days after the 7th day of clinical stability assessment.


Enrollment: 80
Study Start Date: August 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133236


Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Luis B Silva-Neto, MD, ScD Post Graduated Program of Federal University Program
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eneida Rejane Rabelo da Silva, Professor, PhD., Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01133236     History of Changes
Other Study ID Numbers: UFRGS and HCPA 09117
First Submitted: November 9, 2009
First Posted: May 28, 2010
Last Update Posted: January 3, 2014
Last Verified: December 2013

Keywords provided by Eneida Rejane Rabelo da Silva, Hospital de Clinicas de Porto Alegre:
Salt restriction
Fluid restriction
Congestion
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases