Effect of Dietary Sodium Restriction in the Management of Patients With Heart Failure and Diastolic Dysfunction
Primary Purpose
Diastolic Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Sodium restriction
Sponsored by
About this trial
This is an interventional treatment trial for Diastolic Dysfunction focused on measuring diastolic dysfunction, Sodium restriction, Randomized clinical trial
Eligibility Criteria
Inclusion Criteria:
- Patients of both sexes
- Age equal to or above 18 years
- Diagnosis of heart failure whit preserved ejection fraction (LVEF> 50%)
- Patients hospitalized for heart failure decompensation whit hospital admission within 36 hours, who agree to participate in the study by signing the informed consent.
Exclusion Criteria:
- Patients who present values of endogenous creatinine clearance less than or equal to 30 ml / min;
- Cardiogenic shock,
- Those with survival compromised by another disease in evolution and / or difficulty adhering to treatment (dementia, cognitive impairment)
Sites / Locations
- Hospital de Clinicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Sodium restriction (1.6g sodium daily - 4g salt) combined with 800 ml of fluid intake
Normal sodium diet (4g sodium daily - 10g salt) and free fluid intake
Outcomes
Primary Outcome Measures
Weight loss
Secondary Outcome Measures
Assessment of clinical stability
Symptomatic improvement without evidence of congestion (congestion score)
Weight stable for two days, without changing more than 1kg, (daily weight)
Without IV drug for HF for 48 hours (daily record of medication: diuretics, vasodilators)
No increase in diuretic dose for 48 hours (daily records of medications)
Neurohormonal activation
Assessment of neurohormonal activation shall include measurement of serum renin, aldosterone, and BNP levels.
Daily perception of thirst
A visual scale (with values ranging from 0 to 10) will be used daily to verify the degree of thirst.
Readmission rate at 30 days
Full Information
NCT ID
NCT01896908
First Posted
July 8, 2013
Last Updated
August 1, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT01896908
Brief Title
Effect of Dietary Sodium Restriction in the Management of Patients With Heart Failure and Diastolic Dysfunction
Official Title
Effect of Dietary Sodium Restriction in the Management of Patients With Heart Failure and Preserved Ejection Fraction: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
July 31, 2016 (Actual)
Study Completion Date
July 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Although half of the patients with HF has normal ejection fraction or slightly altered (HF-PEF) and the prognosis differs little from those with reduced ejection fraction, the pathophysiology of HF-PEF is still poorly understood.
Sodium restriction is the most common measure of self-care oriented to HF patients for management of congestive episodes. The role of this orientation in the treatment of patients with preserved ejection fraction, however, is still unclear. The evaluation of the effects of sodium restriction on neurohormonal activation and episodes of decompensation in HF-PEF can promote a better understanding of the pathophysiological progression of this complex syndrome.
Detailed Description
This is a randomized, parallel trial with blinded outcome assessment. The sample will include adult patients (aged ≥18 years) with a diagnosis of HF-PEF admitted for HF decompensation. The patients will be randomized to receive a diet with sodium and fluid intake restricted to 0.8 g/day and 800 mL/day respectively (intervention group) or an unrestricted diet, with 4 g/day sodium and unlimited fluid intake (control group), and followed for 7 days or until hospital discharge. The primary outcome shall consist of weight loss at 7 days or discharge. The secondary outcome includes assessment of clinical stability, neurohormonal activation, daily perception of thirst and readmission rate at 30 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Dysfunction
Keywords
diastolic dysfunction, Sodium restriction, Randomized clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Sodium restriction (1.6g sodium daily - 4g salt) combined with 800 ml of fluid intake
Arm Title
Control
Arm Type
No Intervention
Arm Description
Normal sodium diet (4g sodium daily - 10g salt) and free fluid intake
Intervention Type
Other
Intervention Name(s)
Sodium restriction
Intervention Description
Patients that are eligible and fulfill the inclusion criteria will be invited to participate while hospitalized, and then sign the informed consent form. Then, the dietitian on call will be notified in order to change the dietary map of the patients. The prescription diet for both the intervention and control group will be the same: DIET AS RESEARCH PROTOCOL. PATIENT WILL RECEIVE THE DIET UNTIL DAY __ / __ OR DISCHARGE. PLEASE DO NOT CHANGE IT. This will be combined with the medical staff and with the Nutrition and Dietetics service.
The evaluation of outcomes after hospital discharge will be held in the institution of reference when will be performed clinical evaluation and blood samples collection for neurohormonal activation analysis.
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
seven days or hospital discharge
Secondary Outcome Measure Information:
Title
Assessment of clinical stability
Description
Symptomatic improvement without evidence of congestion (congestion score)
Weight stable for two days, without changing more than 1kg, (daily weight)
Without IV drug for HF for 48 hours (daily record of medication: diuretics, vasodilators)
No increase in diuretic dose for 48 hours (daily records of medications)
Time Frame
Seven days or hospital discharge
Title
Neurohormonal activation
Description
Assessment of neurohormonal activation shall include measurement of serum renin, aldosterone, and BNP levels.
Time Frame
On admission and at discharge
Title
Daily perception of thirst
Description
A visual scale (with values ranging from 0 to 10) will be used daily to verify the degree of thirst.
Time Frame
Seven days or hospital discharge
Title
Readmission rate at 30 days
Time Frame
Patients shall be followed for 30 days after discharge.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both sexes
Age equal to or above 18 years
Diagnosis of heart failure whit preserved ejection fraction (LVEF> 50%)
Patients hospitalized for heart failure decompensation whit hospital admission within 36 hours, who agree to participate in the study by signing the informed consent.
Exclusion Criteria:
Patients who present values of endogenous creatinine clearance less than or equal to 30 ml / min;
Cardiogenic shock,
Those with survival compromised by another disease in evolution and / or difficulty adhering to treatment (dementia, cognitive impairment)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eneida Rabelo da Silva, ScD
Organizational Affiliation
HCPA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035003
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29793053
Citation
Machado d'Almeida KS, Rabelo-Silva ER, Souza GC, Trojahn MM, Santin Barilli SL, Aliti G, Rohde LE, Biolo A, Beck-da-Silva L. Aggressive fluid and sodium restriction in decompensated heart failure with preserved ejection fraction: Results from a randomized clinical trial. Nutrition. 2018 Oct;54:111-117. doi: 10.1016/j.nut.2018.02.007. Epub 2018 Mar 21.
Results Reference
derived
PubMed Identifier
25187436
Citation
d'Almeida KS, Rabelo-Silva ER, Souza GC, Trojahn MM, Barilli SL, Mansson JV, Biolo A, Rohde LE, Clausell N, Beck-da-Silva L. Effect of fluid and dietary sodium restriction in the management of patients with heart failure and preserved ejection fraction: study protocol for a randomized controlled trial. Trials. 2014 Sep 4;15:347. doi: 10.1186/1745-6215-15-347.
Results Reference
derived
Learn more about this trial
Effect of Dietary Sodium Restriction in the Management of Patients With Heart Failure and Diastolic Dysfunction
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