Complex Pathophysiological Background of Heart Failure Deterioration

Heart Failure Clinical Trial

Official title:

Multiparametric Assessment of Complex Pathophysiological Background of Heart Failure Deterioration - Relation to Treatment Effects and Prognosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355769
• Other study ID #: WIM-0000000213
• Status: Completed
• Start date: December 2014
• Est. completion date: June 2018

Study information

• Verified date: November 2018
• Source: Military Institute of Medicine, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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))

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Poland	Military Institute of Medicine	Warsaw	Mazovia

Sponsors (1)

Lead Sponsor	Collaborator
Military Institute of Medicine, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	significant electrolyte disturbances (K <3,0mmol/l; Na < 120mmol/l and or change in Na 10 mmol/l)	time frame - assumed mean time of hospitalization	8 days
Other	symptomatic hypotension (SBP <90 mmHg or change in40 mmHg)	time frame - assumed mean time of hospitalization	8 days
Other	hospitalization time (days)	time frame - assumed mean time of hospitalization	8 days
Other	change in NYHA class	time frame - assumed mean time of hospitalization	8 days
Other	"diuretic effectiveness ratio" - change in body mass change [%]/diuretics use [mg]	time frame - assumed mean time of hospitalization	8 days
Other	change in HR	time frame - assumed mean time of hospitalization	8 days
Other	change in SBP	time frame - assumed mean time of hospitalization	8 days
Other	change in DBP	time frame - assumed mean time of hospitalization	8 days
Other	change in SI	time frame - assumed mean time of hospitalization	8 days
Other	change in CI	time frame - assumed mean time of hospitalization	8 days
Other	change in TFC	time frame - assumed mean time of hospitalization	8 days
Other	change in SVRI	time frame - assumed mean time of hospitalization	8 days
Other	change in body mass	time frame - assumed mean time of hospitalization	8 days
Other	change in TBW	time frame - assumed mean time of hospitalization	8 days
Other	change in ECW	time frame - assumed mean time of hospitalization	8 days
Other	change in ICW	time frame - assumed mean time of hospitalization	8 days
Other	change in bilirubin	time frame - assumed mean time of hospitalization	8 days
Other	change in eGFR	time frame - assumed mean time of hospitalization	8 days
Other	change in urea	time frame - assumed mean time of hospitalization	8 days
Other	change in hemoglobin	time frame - assumed mean time of hospitalization	8 days
Other	change in hematocrit	time frame - assumed mean time of hospitalization	8 days
Other	change in NTproBNP	time frame - assumed mean time of hospitalization	8 days
Other	change in pH	time frame - assumed mean time of hospitalization	8 days
Other	change in lactates	time frame - assumed mean time of hospitalization	8 days
Primary	in-hospital death	time frame - assumed mean time of hospitalization	8 days
Primary	combined primary endpoint (in-hospital death and/or myocardial infract and/or stroke and/or serious arrhythmia and/or worsening renal function)	time frame - assumed mean time of hospitalization	8 days
Secondary	myocardial infract	time frame - assumed mean time of hospitalization	8 days
Secondary	stroke (clinical symptoms and confirmed in CT)	time frame - assumed mean time of hospitalization	8 days
Secondary	serious arrhythmia (new onset sustained ventricular tachycardia/fibrillation, supraventricular tachycardia, atrial fibrillation/flutter, sustained bradycardia <40/min)	time frame - assumed mean time of hospitalization	8 days
Secondary	worsening renal function (increase in creatinine 0,3mg/dl according to the definition of AKDI)	time frame - assumed mean time of hospitalization	8 days