- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02355769
Complex Pathophysiological Background of Heart Failure Deterioration
Multiparametric Assessment of Complex Pathophysiological Background of Heart Failure Deterioration - Relation to Treatment Effects and Prognosis
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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))
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Mazovia
-
Warsaw, Mazovia, Polen, 04-141
- Military Institute of Medicine
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
in-hospital death
Tidsramme: 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)
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
myocardial infract
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
stroke (clinical symptoms and confirmed in CT)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
significant electrolyte disturbances (K <3,0mmol/l; Na < 120mmol/l and or change in Na 10 mmol/l)
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
symptomatic hypotension (SBP <90 mmHg or change in40 mmHg)
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
hospitalization time (days)
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in NYHA class
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
"diuretic effectiveness ratio" - change in body mass change [%]/diuretics use [mg]
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in HR
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in SBP
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in DBP
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in SI
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in CI
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in TFC
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in SVRI
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in body mass
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in TBW
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in ECW
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in ICW
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in bilirubin
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in eGFR
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in urea
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in hemoglobin
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in hematocrit
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in NTproBNP
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in pH
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
change in lactates
Tidsramme: 8 days
|
time frame - assumed mean time of hospitalization
|
8 days
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Pawel Krzesinski, MD, PhD, Military Institute of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- WIM-0000000213
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