- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
New York
-
Stony Brook, New York, Estados Unidos, 11794
- Stony Brook University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: 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
|
Comparador Ativo: B: 3 gr of Sodium
Meal Plans with 3 gr of Sodium
|
Dietary plan with 1.5 gr vs 3 gr of Sodium
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Patient On-Study Retention
Prazo: 3 month meal plan
|
Percentage of patients retained in the study
|
3 month meal plan
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
All cause mortality
Prazo: 6 months follow up period
|
Percentage of patients died
|
6 months follow up period
|
Rehospitalization
Prazo: 6 months follow up period
|
Percentage of patients rehospitalized
|
6 months follow up period
|
Emergency room visits
Prazo: 6 months follow up period
|
Percentage of patients visited emergency room
|
6 months follow up period
|
NT-proBNP
Prazo: 6months follow up period
|
Concentration in pg/ml
|
6months follow up period
|
Kansas City Cardiomyopathy Questionnaire
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Systolic Blood Pressure
Prazo: 6 month follow up
|
'mmHg'
|
6 month follow up
|
Creatinine
Prazo: 6 month follow up
|
'mg/dl'
|
6 month follow up
|
Blood Urea Nitrogen
Prazo: 6 month follow up
|
'mg/dl'
|
6 month follow up
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Javed Butler, MD, MPH, MBA, Stony Brook University
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1R34HL119773 (Concessão/Contrato do NIH dos EUA)
- 639316 (Outro identificador: Stony Brook CORIHS A)
- R34HL119773 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Insuficiência cardíaca
-
Region SkåneInscrevendo-se por conviteInsuficiência Cardíaca Classe II da New York Heart Association (NYHA) | Insuficiência Cardíaca Classe III da New York Heart Association (NYHA)Suécia
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University... e outros colaboradoresAinda não está recrutandoInsuficiência Cardíaca Sistólica | Insuficiência Cardíaca com Fração de Ejeção Reduzida | Insuficiência Cardíaca Classe IV da New York Heart Association | Insuficiência Cardíaca Classe III da New York Heart AssociationPolônia
-
University of WashingtonAmerican Heart AssociationConcluídoInsuficiência Cardíaca, Congestiva | Alteração Mitocondrial | Insuficiência Cardíaca Classe IV da New York Heart AssociationEstados Unidos