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Complex Pathophysiological Background of Heart Failure Deterioration

10. November 2018 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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))

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

102

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
in-hospital death
Zeitfenster: 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)
Zeitfenster: 8 days
time frame - assumed mean time of hospitalization
8 days

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
myocardial infract
Zeitfenster: 8 days
time frame - assumed mean time of hospitalization
8 days
stroke (clinical symptoms and confirmed in CT)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 8 days
time frame - assumed mean time of hospitalization
8 days

Andere Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Dezember 2014

Primärer Abschluss (Tatsächlich)

1. Juni 2017

Studienabschluss (Tatsächlich)

1. Juni 2018

Studienanmeldedaten

Zuerst eingereicht

22. Januar 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Januar 2015

Zuerst gepostet (Schätzen)

4. Februar 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. November 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. November 2018

Zuletzt verifiziert

1. November 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • WIM-0000000213

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