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.
Studieoversikt
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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RS
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Porto Alegre, RS, Brasil, 90035003
- Hospital de Clínicas de Porto Alegre
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Intervention
Sodium restriction (1.6g sodium daily - 4g salt) combined with 800 ml of fluid intake
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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. |
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Ingen inngripen: Control
Normal sodium diet (4g sodium daily - 10g salt) and free fluid intake
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Weight loss
Tidsramme: seven days or hospital discharge
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seven days or hospital discharge
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Assessment of clinical stability
Tidsramme: Seven days or hospital discharge
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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
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Neurohormonal activation
Tidsramme: On admission and at discharge
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Assessment of neurohormonal activation shall include measurement of serum renin, aldosterone, and BNP levels.
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On admission and at discharge
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Daily perception of thirst
Tidsramme: Seven days or hospital discharge
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A visual scale (with values ranging from 0 to 10) will be used daily to verify the degree of thirst.
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Seven days or hospital discharge
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Readmission rate at 30 days
Tidsramme: Patients shall be followed for 30 days after discharge.
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Patients shall be followed for 30 days after discharge.
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Eneida Rabelo da Silva, ScD, HCPA
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HCPA - 120437
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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