Status:
NOT_YET_RECRUITING
Determination of Drug Levels for Pharmacotherapy of Heart Failure
Lead Sponsor:
University Hospital Ostrava
Conditions:
Cardiovascular Diseases
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to determine whether and how serum concentrations of the used medicinal products, including their metabolites, correlate with selected clinical indicators of heart failure (NT...
Detailed Description
The prevalence of chronic heart failure increases with age, and this disease is one of the most common reasons for hospitalization in the elderly. In order to reduce the number of exacerbations, the f...
Eligibility Criteria
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 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
- 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
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06035978
Start Date
March 1 2024
End Date
April 1 2026
Last Update
January 18 2024
Active Locations (1)
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1
University Hospital Ostrava
Ostrava, Czech Republic, Czechia, 70852