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Use of determination of drug levels to optimize pharmacotherapy of heart failure
EU CTIS ID: 2023-506283-13-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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 - severe hypotension (systolic blood pressure <85 mmHg)
- 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 - untreated pheochromocytoma
- Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - metabolic acidosis
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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 - severe hypotension (systolic blood pressure <85 mmHg)
- 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 - untreated pheochromocytoma
- Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - metabolic acidosis
- Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - severe peripheral arterial circulation disorders
- 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 Spironolactone - anuria
- 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)
- Pregnant and breastfeeding women
- 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 - Addison's disease
- Additional exclusion criteria for patients using Spironolactone - concurrent use of eplerenone or other potassium-sparing diuretics
- Additional exclusion criteria for patients using Spironolactone - porphyria
- 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
- Additional exclusion criteria for patients using Sacubitril/Valsartan - hereditary or idiopathic angioedema
- 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 Sacubitril/Valsartan - severe liver dysfunction, biliary cirrhosis and cholestasis
- 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 - Clinically manifest liver dysfunction
- 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 - 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 - severe bradycardia (heart rate <50)
- Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - cardiogenic shock
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.