- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02355769
Complex Pathophysiological Background of Heart Failure Deterioration
Multiparametric Assessment of Complex Pathophysiological Background of Heart Failure Deterioration - Relation to Treatment Effects and Prognosis
Visão geral do estudo
Status
Condições
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
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Mazovia
-
Warsaw, Mazovia, Polônia, 04-141
- Military Institute of Medicine
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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
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
Patrocinador
Investigadores
- Investigador principal: Pawel Krzesinski, MD, PhD, Military Institute of Medicine
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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
Termos MeSH relevantes adicionais
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 .
Ensaios clínicos em Insuficiência cardíaca
-
Region SkaneInscrevendo-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