Determination of Drug Levels for Pharmacotherapy of Heart Failure
Cardiovascular Diseases, Heart Failure With Reduced Ejection Fraction
About this trial
This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Cardiovascular Diseases, Heart Failure with Reduced Ejection Fraction
Eligibility Criteria
Inclusion Criteria: HFrEF with already established or newly started treatment with the listed medicinal products Male and female patients over 18 years of age Signed Informed Consent with participation in the study Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) result at baseline and use an acceptable method of contraception with a home control urine pregnancy test every 3 months throughout the duration of the study Exclusion Criteria: Hypersensitivity to the medicinal substance or to any auxiliary substance Pregnant and breastfeeding women Additional exclusion criteria for patients taking Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol: Unstable or decompensated heart failure belonging to New York Heart Association (NYHA) group IV according to the New York Heart Association classification, requiring intravenous inotropic support Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol: - Clinically manifest liver dysfunction - History of bronchospasm or asthma - Severe obstructive airways disease - 2nd and 3rd degree A-V block (unless a permanent pacemaker is implanted) - severe bradycardia (heart rate <50) - 2nd and 3rd degree A-V block (unless a permanent pacemaker is implanted) - severe bradycardia (heart rate <50) - cardiogenic shock - sinus node dysfunction syndrome (including sinoatrial block) - severe hypotension (systolic blood pressure <85 mmHg) - Prinzmetal angina - untreated pheochromocytoma - metabolic acidosis - severe peripheral arterial circulation disorders - concurrent intravenous treatment with verapamil or diltiazem Additional exclusion criteria for patients using Spironolactone: - anuria - acute renal failure - severe renal impairment (estimated glomerular filtration rate <10 ml/min) - hyperkalemia >5.5 mmol/l - hyponatremia <125 mmol/l - Addison's disease - concurrent use of eplerenone or other potassium-sparing diuretics - porphyria Additional exclusion criteria for patients using Sacubitril/Valsartan: - concomitant use with Angiotensin converting enzyme (ACE) inhibitors - angioedema related to previous ACE inhibitor treatment or a history of angiotensin II receptor blockers (ARB) treatment - hereditary or idiopathic angioedema - concomitant use with medicinal products containing Aliskiren in patients with diabetes mellitus or in patients with impaired renal function (eGFR <60 ml/min/1.73 m2) - severe liver dysfunction, biliary cirrhosis and cholestasis
Sites / Locations
- University Hospital Ostrava
Arms of the Study
Arm 1
Experimental
Patients with Heart Failure with Reduced Ejection Fraction
Patients with heart failure with reduced ejection fraction, aged 18+, dispensary at the Cardiology Outpatient Clinic for Heart Failure University Hospital Ostrava, who are orally administered tablets one of the evaluated medicinal products or their combination as indicated by the attending physician (Nebivolol, Valsartan and Sacubitril, Carvedilol, Bisoprolol, Metoprolol, Spironolactone).