Use of determination of drug levels to optimize pharmacotherapy of heart failure
Key facts
- Where
- Poruba, CsehországSee the site
- Phase
- 4. fázis
Where in Csehország
- Fakultni Nemocnice OstravaPoruba, CsehországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fakultni Nemocnice Ostrava
- Trial code
- EU 2023-506283-13-00
- Record updated
- 2024. március 12.
- Original description
The primary objective of the CT is to determine whether and how the serum concentrations of the listed medicinal products, including their metabolites, correlate with selected clinical indicators of heart failure.Read full original descriptionShow less
The primary objective of the CT is to determine whether and how the serum concentrations of the listed medicinal products, including their metabolites, correlate with selected clinical indicators of heart failure.
Inclusion: 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 the initial visit and use an acceptable method of contraception with a home control urine pregnancy test every 3 months throughout the duration of the study.
Exclusion: Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - concurrent intravenous treatment with verapamil or diltiazem; Additional exclusion criteria for patients using Sacubitril/Valsartan - concomitant use with ACE inhibitors; Additional exclusion criteria for patients using Sacubitril/Valsartan - angioedema related to previous ACE inhibitor treatment or a history of ARB treatment; Hypersensitivity to the medicinal substance or to any auxiliary substance; Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - sinus node dysfunction syndrome (including sinoatrial block); Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - Prinzmetal angina; Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - severe peripheral arterial circulation disorders; Additional exclusion criteria for patients using Spironolactone - acute renal failure; Additional exclusion criteria for patients using Spironolactone - severe renal impairment (estimated glomerular filtration rate <10 ml/min); Additional exclusion criteria for patients using Spironolactone - Addison's disease; Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - Unstable or decompensated heart failure belonging to the NYHA IV group according to the New York Heart Association classification, requiring intravenous inotropic support; Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - History of bronchospasm or asthma; Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - Severe obstructive airways disease; Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - severe bradycardia (heart rate <50); Additional exclusion criteria for patients using Spironolactone - hyperkalemia >5.5 mmol/l; Additional exclusion criteria for patients using Spironolactone - hyponatremia <125 mmol/l; Additional exclusion criteria for patients using Spironolactone - concurrent use of eplerenone or other potassium-sparing diuretics; Additional exclusion criteria for patients using Sacubitril/Valsartan - 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); Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - severe hypotension (systolic blood pressure <85 mmHg); Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - untreated pheochromocytoma; Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - metabolic acidosis; Additional exclusion criteria for patients using Spironolactone - anuria; Pregnant and breastfeeding women; Additional exclusion criteria for patients using Spironolactone - porphyria; Additional exclusion criteria for patients using Sacubitril/Valsartan - hereditary or idiopathic angioedema; Additional exclusion criteria for patients using Sacubitril/Valsartan - severe liver dysfunction, biliary cirrhosis and cholestasis; Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - Clinically manifest liver dysfunction; Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - 2nd and 3rd degree A-V block (unless a permanent pacemaker is implanted); Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - cardiogenic shock.