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Fluid and Salt Restriction in Decompensated Heart Failure Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eneida Rejane Rabelo da Silva, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01133236
First received: November 9, 2009
Last updated: December 31, 2013
Last verified: December 2013
  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 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

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Hospital de Clinicas de Porto Alegre

Additional 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
Study First Received: November 9, 2009
Last Updated: December 31, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Salt restriction
Fluid restriction
Congestion
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014