Fluid and Salt Restriction in Decompensated Heart Failure Patients
Randomized Clinical Trial to Assess the Effect of Fluid and Salt Restriction on the Management of Patients Hospitalized Due to Decompensated Heart Failure
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Aug 2009
Typical duration for not_applicable heart-failure
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 9, 2009
CompletedFirst Posted
Study publicly available on registry
May 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedJanuary 3, 2014
December 1, 2013
3.1 years
November 9, 2009
December 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Bodyweight loss
Daily weight on a digital scale
7 days
Clinical stability
Clinical assessment daily for 7 days.
Seven days.
Secondary Outcomes (3)
Health state evaluation.
30 days
Evaluation of thirst sensation.
Seven days
Re-hospitalizations.
30 days
Study Arms (1)
Salt and Fluid
EXPERIMENTALIntervention: Fluid 800 Ml and Salt 2 g per day Control: FLuid and Salt Free
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 23689381DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luis B Silva-Neto, MD, ScD
Post Graduated Program of Federal University Program
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, PhD.
Study Record Dates
First Submitted
November 9, 2009
First Posted
May 28, 2010
Study Start
August 1, 2009
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
January 3, 2014
Record last verified: 2013-12