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.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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RS
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Porto Alegre, RS, 브라질, 90035003
- Hospital De Clinicas De Porto Alegre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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간섭 없음: Control
Normal sodium diet (4g sodium daily - 10g salt) and free fluid intake
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Weight loss
기간: seven days or hospital discharge
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seven days or hospital discharge
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Assessment of clinical stability
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Eneida Rabelo da Silva, ScD, HCPA
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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