Effect of Dietary Sodium Restriction in the Management of Patients With Heart Failure and Diastolic Dysfunction
Effect of Dietary Sodium Restriction in the Management of Patients With Heart Failure and Preserved Ejection Fraction: a Randomized Clinical Trial
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
RS
-
Porto Alegre, RS, Brasilien, 90035003
- Hospital de Clinicas de Porto Alegre
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intervention
Sodium restriction (1.6g sodium daily - 4g salt) combined with 800 ml of fluid intake
|
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. |
|
Inget ingripande: Control
Normal sodium diet (4g sodium daily - 10g salt) and free fluid intake
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Weight loss
Tidsram: seven days or hospital discharge
|
seven days or hospital discharge
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Assessment of clinical stability
Tidsram: Seven days or hospital discharge
|
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) |
Seven days or hospital discharge
|
|
Neurohormonal activation
Tidsram: On admission and at discharge
|
Assessment of neurohormonal activation shall include measurement of serum renin, aldosterone, and BNP levels.
|
On admission and at discharge
|
|
Daily perception of thirst
Tidsram: Seven days or hospital discharge
|
A visual scale (with values ranging from 0 to 10) will be used daily to verify the degree of thirst.
|
Seven days or hospital discharge
|
|
Readmission rate at 30 days
Tidsram: Patients shall be followed for 30 days after discharge.
|
Patients shall be followed for 30 days after discharge.
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Eneida Rabelo da Silva, ScD, HCPA
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HCPA - 120437
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .