- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02467296
Dietary Sodium Intake and Outcomes in Heart Failure (PROHIBITSodium)
Rationale and Design of the PRevent Adverse Outcomes in Heart faIlure By limITing Sodium Study
연구 개요
상세 설명
Despite the intense research for improving outcomes in heart failure, evidence remains scarce (and mostly observational) for dietary sodium restriction, arguably the most widely recommended self-care measure for heart failure. In explicit acknowledgement of the evidence gaps and unclear benefits, the recent European Society of Cardiology guidelines have not assigned a level of evidence to sodium intake recommendations and the American College of Cardiology (ACC) and American Heart Association (AHA) guidelines do not provide a specific target level of sodium intake for patients with HF.
Although it seems reasonable to restrict sodium below <3000 mg/d in heart failure, it is currently unknown how "low" is appropriate for these patients.
This study will attempt to provide the basis to evaluate the above guidelines by determining, in consecutive HFrEF patients with EF ≤40% during an acute HF admission, the proportion of patients who: (1) are willing to participate in a 12-week feeding trial; (2) meet the trial eligibility criteria; and (C) subsequently continue to consume ≥3000 mg/d sodium 15-30 days post discharge despite discharge instructions. This will allow the investigators to estimate enrollment rates in a full-scale trial.
This study will randomize 50 eligible patients to prepared meal plans with either 1500 mg/d vs. 3000 mg/d sodium for 12 weeks .
The hypotheses of the present study are that (1) ≥ 90% of patients will be retained on the study by 12 weeks (or at first outcome or safety event) and (2) patients will be compliant with provided food ≥ 90% of the study days.
Study Primary Endpoints:
(i) Overall on-study retention and (ii) compliance with the prepared food, assessed via daily food diaries and 24-h urine collections at baseline, 4, 8, and 12 weeks.
Study Secondary Endpoints:
Estimate trends in (1) all-cause mortality, readmissions, and emergency room visits; (2) NT-pro-B-type natriuretic peptide levels; and (3) diet palatability and quality of life, between the two arms.
Safety endpoints:
Safety of the intervention assessed by vital sign and laboratory assessments. This pilot study is expected to yield critical information necessary and sufficient to design a full-scale clinical trial that will provide evidence for dietary sodium recommendations in heart failure.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
New York
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Stony Brook, New York, 미국, 11794
- Stony Brook University
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ≥21 years at screening
- Recent (≤1 year) EF ≤40%
- Standard HF treatment, including ACEI/ARB & beta-blockers & aldosterone antagonists, unless contraindicated or intolerant
5. Able to consume research diet (e.g. no dysphagia etc.) 6. Systolic blood pressure ≥100 mmHg 7. >3000 mg/d sodium excretion (by 24-hr urinary sodium)
Exclusion Criteria:
- Institutionalized patients
- Siogns or symptoms of instability in HF status
- Communication barriers, including cognitive impairment; inability to communicate and understand and cooperate with the protocol
- Severe non-cardiac illness that compromises life expectancy within the next 12 months or the ability to participate in the study (e.g. severe hepatobiliary disease, cancer underground chemo- or radiotherapy)
- Any medical or surgical procedure planned in the next 6 months
- Participants planning to move to a different state within 6 months
- Participation in any other experimental protocol
- Renal replacement therapy or Stage 4 or 5 chronic kidney disease
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: A: 1.5 gr of Sodium
Meal Plans with 1.5 gr of Sodium
|
Dietary plan with 1.5 gr vs 3 gr of Sodium
|
활성 비교기: B: 3 gr of Sodium
Meal Plans with 3 gr of Sodium
|
Dietary plan with 1.5 gr vs 3 gr of Sodium
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Patient On-Study Retention
기간: 3 month meal plan
|
Percentage of patients retained in the study
|
3 month meal plan
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
All cause mortality
기간: 6 months follow up period
|
Percentage of patients died
|
6 months follow up period
|
Rehospitalization
기간: 6 months follow up period
|
Percentage of patients rehospitalized
|
6 months follow up period
|
Emergency room visits
기간: 6 months follow up period
|
Percentage of patients visited emergency room
|
6 months follow up period
|
NT-proBNP
기간: 6months follow up period
|
Concentration in pg/ml
|
6months follow up period
|
Kansas City Cardiomyopathy Questionnaire
기간: 6 months follow up period
|
The 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ) measures health status in patients with heart failure (HF), KCCQ has 6 domains and 2 summary scores: Symptom Domain: frequency and burden of symptoms. Physical Function Domain: limitations. Quality of Life (QoL) Domain: reflects QoL Social Limitation Domain: ability to interact in social activities. Self-efficacy Domain: patients' perceptions of how to prevent HF exacerbations. Symptom Stability Domain: recent changes in symptoms. Clinical Summary Score includes total symptom and physical function. Overall Summary Score includes the total symptom, physical function, social limitations and QoL scores. The KCCQ is scored by assigning each response an ordinal value, beginning with 1. Scale scores are transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. Best is 100. |
6 months follow up period
|
Food Palatability Questionnaire
기간: 6 months follow up period
|
Likert Scales for appearance, taste, and quantity of food (from 1 to 5 - 5 being the most acceptable)
|
6 months follow up period
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Systolic Blood Pressure
기간: 6 month follow up
|
'mmHg'
|
6 month follow up
|
Creatinine
기간: 6 month follow up
|
'mg/dl'
|
6 month follow up
|
Blood Urea Nitrogen
기간: 6 month follow up
|
'mg/dl'
|
6 month follow up
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Javed Butler, MD, MPH, MBA, Stony Brook University
간행물 및 유용한 링크
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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