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Complex Pathophysiological Background of Heart Failure Deterioration

10 de novembro de 2018 atualizado por: Paweł Krzesiński, Military Institute of Medicine, Poland

Multiparametric Assessment of Complex Pathophysiological Background of Heart Failure Deterioration - Relation to Treatment Effects and Prognosis

Preventing heart failure (HF) deterioration is a great challenge for contemporary medicine. The progress course of HF is with increasing frequency of subsequent hospitalizations (approximately 30% of hospitalizations are the repeated ones). It is estimated that the costs of hospital stays constitute nearly 2/3 of healthcare costs provided for HF patients. The difficulty in treatment of patients with HF deterioration is associated with numerous comorbidities and coexisting complications (i.e. aggravation of ischaemic heart disease, lung diseases, infections, electrolyte disturbances, anaemia, renal failure as well as operations, in particular emergency ones). Our study is aimed to evaluation the complex pathophysiological background related to heart failure deterioration with respect to the effect of applied in-hospital treatment.

Visão geral do estudo

Status

Concluído

Descrição detalhada

PURPOSE:

Treatment of patients with heart failure (HF) is a great challenge for contemporary medicine. HF frequency in European population is assessed for 0.4 - 2%. This disease is characterized by high morbidity and mortality rate, poor quality of life and the necessity of frequent hospitalizations. Along with the medicine progress, in particular in the scope of acute coronary syndromes treatment, the number of HF patients is constantly growing. The essential problem connected with HF is its progress course and an increasing frequency of subsequent hospitalizations (approximately 30% of hospitalizations are the repeated ones). It is estimated that the costs of hospital stays constitute nearly 2/3 of healthcare costs provided for HF patients. In the United States approximately 50% of HF patients have been rehospitalized within 6 months from discharge and 70% of these hospitalizations were caused by HF deterioration.The prognosis in HF is closely connected with the progression of the disease defined in accordance with the NYHA (New York Heart Association) functional classification. The yearly mortality rate among each NYHA class is: class 1 - up to 10%, class 2 - 10-20%, class 3 - 20-40%, class 4 - mortality 40-60%. Over half of the patients with symptomatic HF die within 4 years of observation The high in-hospital mortality has been a great problem and results not only from the natural history of HF progression, but also from a number of coexisting complications (i.e. aggravation of ischaemic heart disease, lung diseases, infections, electrolyte disturbances, anaemia, renal failure as well as operations, in particular emergency ones). The optimal schemes of identifying the individual risk are of fundamental importance to guide the safe therapy. Undoubtedly hemodynamic status and its change during hospitalization is one of the main predictive factors of treatment response and occurrences of adverse effects of therapy, i.e. renal function worsening. However, there are no clear guidelines on how to perform safe and effective non-invasive hemodynamic monitoring.

AIMS:

The evaluation of complex pathophysiological features related to heart failure deterioration, including the parameters characterizing i.e. cardiovascular hemodynamics, hydration status, renal failure, iron metabolism and gas exchange, with respect to the effect of applied in-hospital treatment The evaluation of clinical value of the parameters characterizing i.e. cardiovascular hemodynamics, hydration status, renal failure, iron metabolism and gas exchange in prognosis of patients with heart failure deterioration

METHODS:

All the recruited patients will undergo the following assessment:

Clinical examination Laboratory tests, ncluding i.e. white blood cells count, red blood cells count, hemoglobin, hematocrit, mean cell volume (MCV), red cell distribution width (RDW); sodium, potassium, creatinine, estimated glomerular filtration rat (eGFR), urea, cystatin C; fasting glucose; bilirubin; total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides, N-terminal of the prohormone brain natriuretic peptide (NT-proBNP); hs-TnT (high sensitive troponin T), iron; ferritin; unsaturated iron binding capacity (UIBC), total iron binding capacity (TIBC), transferrin saturation, soluble transferrin receptor; pH, carbon dioxide partial pressure (pCO2), oxygen partial pressure (pO2), arterial oxygen saturation (SaO2), bicarbonate content (HCO3-), base excess (BE), lactates; thyroid-stimulating hormone (TSH), testosterone, dehydroepiandrosterone sulfate (DHEAS), estradiol Electrocardiogram Echocardiography Chest X-ray Holter-ekg monitoring ambulatory blood pressure monitoring impedance cardiography (including assessment of: resting heart rate (HR), systolic and diastolic blood pressure (SBP and DBP), thoracic fluid content (TFC), cardiac index (CI), stroke index (SI), systemic vascular resistance index (SVRI) bioimpedance (including assessment total body water (TBW), intracellular and extracellular water (ICW, ECW)) applanation tonometry (including assessment of augmentation index (AI) and central pulse pressure (CPP))

Tipo de estudo

Observacional

Inscrição (Real)

102

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Mazovia
      • Warsaw, Mazovia, Polônia, 04-141
        • Military Institute of Medicine

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients with heart failure admitted to the Department of Internal Diseases and Cardiology urgently because of symptomatic heart failure deterioration

Descrição

Inclusion Criteria:

  • patients of either sex
  • urgent hospitalization caused by deterioration of HF.

Exclusion Criteria:

  • unstable coronary artery disease including myocardial infarct within the last 40 days prior to recruitment
  • stroke within 40 days prior to recruitment
  • cardiac surgery within 90 days prior to recruitment
  • pulmonary embolism
  • severe pulmonary diseases (chronic obstructive pulmonary diseases - stage C/D, uncontrolled asthma, pulmonary hypertension)
  • chronic kidney disease (stage 5 and requiring dialysis)
  • severe inflammatory disease
  • severe mental and physical disorders
  • patients' refusal to participate

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
in-hospital death
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
combined primary endpoint (in-hospital death and/or myocardial infract and/or stroke and/or serious arrhythmia and/or worsening renal function)
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
myocardial infract
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
stroke (clinical symptoms and confirmed in CT)
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
serious arrhythmia (new onset sustained ventricular tachycardia/fibrillation, supraventricular tachycardia, atrial fibrillation/flutter, sustained bradycardia <40/min)
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
worsening renal function (increase in creatinine 0,3mg/dl according to the definition of AKDI)
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
significant electrolyte disturbances (K <3,0mmol/l; Na < 120mmol/l and or change in Na 10 mmol/l)
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
symptomatic hypotension (SBP <90 mmHg or change in40 mmHg)
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
hospitalization time (days)
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in NYHA class
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
"diuretic effectiveness ratio" - change in body mass change [%]/diuretics use [mg]
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in HR
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in SBP
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in DBP
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in SI
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in CI
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in TFC
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in SVRI
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in body mass
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in TBW
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in ECW
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in ICW
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in bilirubin
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in eGFR
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in urea
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in hemoglobin
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in hematocrit
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in NTproBNP
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in pH
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days
change in lactates
Prazo: 8 days
time frame - assumed mean time of hospitalization
8 days

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Pawel Krzesinski, MD, PhD, Military Institute of Medicine

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de dezembro de 2014

Conclusão Primária (Real)

1 de junho de 2017

Conclusão do estudo (Real)

1 de junho de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

22 de janeiro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de janeiro de 2015

Primeira postagem (Estimativa)

4 de fevereiro de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de novembro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de novembro de 2018

Última verificação

1 de novembro de 2018

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • WIM-0000000213

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 .

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