Clinical trial NCT02355769: Complex Pathophysiological Background of Heart Failure Deterioration
Official title: Multiparametric Assessment of Complex Pathophysiological Background of Heart Failure Deterioration - Relation to Treatment Effects and Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: heart failure
renal failure
prognosis
impedance cardiography
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart failure admitted to the Department of Internal Diseases and Cardiology urgently because of symptomatic heart failure deterioration

Brief summary: 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.

Detailed description: 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))

Eligibility criteria: 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

Primary outcomes:
measure: in-hospital death
timeFrame: 8 days
measure: combined primary endpoint (in-hospital death and/or myocardial infract and/or stroke and/or serious arrhythmia and/or worsening renal function)
timeFrame: 8 days
Secondary outcomes:
measure: myocardial infract
timeFrame: 8 days
measure: stroke (clinical symptoms and confirmed in CT)
timeFrame: 8 days
measure: serious arrhythmia (new onset sustained ventricular tachycardia/fibrillation, supraventricular tachycardia, atrial fibrillation/flutter, sustained bradycardia <40/min)
timeFrame: 8 days
measure: worsening renal function (increase in creatinine 0,3mg/dl according to the definition of AKDI)
timeFrame: 8 days
Other outcomes:
measure: significant electrolyte disturbances (K <3,0mmol/l; Na < 120mmol/l and or change in Na 10 mmol/l)
timeFrame: 8 days
measure: symptomatic hypotension (SBP <90 mmHg or change in40 mmHg)
timeFrame: 8 days
measure: hospitalization time (days)
timeFrame: 8 days
measure: change in NYHA class
timeFrame: 8 days
measure: "diuretic effectiveness ratio" - change in body mass change [%]/diuretics use [mg]
timeFrame: 8 days
measure: change in HR
timeFrame: 8 days
measure: change in SBP
timeFrame: 8 days
measure: change in DBP
timeFrame: 8 days
measure: change in SI
timeFrame: 8 days
measure: change in CI
timeFrame: 8 days
measure: change in TFC
timeFrame: 8 days
measure: change in SVRI
timeFrame: 8 days
measure: change in body mass
timeFrame: 8 days
measure: change in TBW
timeFrame: 8 days
measure: change in ECW
timeFrame: 8 days
measure: change in ICW
timeFrame: 8 days
measure: change in bilirubin
timeFrame: 8 days
measure: change in eGFR
timeFrame: 8 days
measure: change in urea
timeFrame: 8 days
measure: change in hemoglobin
timeFrame: 8 days
measure: change in hematocrit
timeFrame: 8 days
measure: change in NTproBNP
timeFrame: 8 days
measure: change in pH
timeFrame: 8 days
measure: change in lactates
timeFrame: 8 days
Locations:
city: Warsaw
country: Poland
facility: Military Institute of Medicine
state: Mazovia
Study officials:
affiliation: Military Institute of Medicine
name: Pawel Krzesinski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: