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Complex Pathophysiological Background of Heart Failure Deterioration

10. november 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

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

Observasjonsmessig

Registrering (Faktiske)

102

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Pawel Krzesinski, MD, PhD, Military Institute of Medicine

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2014

Primær fullføring (Faktiske)

1. juni 2017

Studiet fullført (Faktiske)

1. juni 2018

Datoer for studieregistrering

Først innsendt

22. januar 2015

Først innsendt som oppfylte QC-kriteriene

30. januar 2015

Først lagt ut (Anslag)

4. februar 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. november 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. november 2018

Sist bekreftet

1. november 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • WIM-0000000213

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