Cardiovascular Diseases, Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
Cardiovascular Diseases, Heart Failure with Reduced Ejection Fraction
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-proBNP concentration, 6-minute walk test, quality of life questionnaire, echocardiographic parameters, hospitalization for HFrEF, length of survival).
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 frequency of hospitalizations, morbidity and mortality and improve the overall quality of life, the treatment strategy should be individually set for each patient, regularly monitored and reviewed. Patients with chronic heart failure show significant differences in the pharmacokinetics of both cardiovascular and non-cardiovascular drugs. At the same time, they tend to be exposed to other prescribed medicinal products, and therefore there is an increased risk of drugs interactions. These findings emphasize the need for comprehensive pharmacokinetic studies in patients with chronic heart failure, together with the exploration of the potential benefit of biomarkers suitable for monitoring the clinical status of patients. Pharmacotherapy of chronic heart failure with reduced ejection fraction (Heart Failure with Reduced Ejection Fraction - HFrEF) currently consists of beta-blockers together with mineralocorticoid receptor antagonists, the combination of sacubitril/valsartan drugs and sodium-glucose transporter 2 inhibitors. Although the recommendation of therapeutic drug monitoring (TDM) in patients with chronic heart failure has not yet been established, its introduction can serve as an effective tool for detecting changes in the pharmacokinetics of drugs used, objectifying drug interactions and ascertaining patient adherence to treatment, thereby becoming part of safe personalized pharmacotherapy of this disease.
Interventions
DRUGNebivolol
Nebivolol (Nebilet) tablet will be administered orally to patients according to their clinical condition and the decision of the attending physician.
Valsartan and Sacubitril (Entresto) tablet will be administered orally to patients according to their clinical condition and the decision of the attending physician.
DRUGCarvedilol
Carvedilol (Dilatrend) tablet will be administered orally to patients according to their clinical condition and the decision of the attending physician.
DRUGBisoprolol
Bisoprolol (Concor) tablet will be administered orally to patients according to their clinical condition and the decision of the attending physician.
DRUGMetoprolol
Metoprolol (Betaloc ZOK) tablet will be administered orally to patients according to their clinical condition and the decision of the attending physician.
DRUGSpironolactone
Verospiron (Spironolactone) tablet will be administered orally to patients according to their clinical condition and the decision of the attending physician.
Sponsors
University Hospital Ostrava
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of the rate of significance between the serum concentration of the used medicinal products and the dose of this medicinal product | 24 month | Determination whether the serum concentration of used medicinal products (Nebivolol, Valsartan/Sacubitril, Carvedilol, Bisoprolol, Metoprolol, Spironolactone) is more important than the dose of these medicinal products for compensating health status in patients with chronic heart failure with reduced ejection fraction (HFrEF). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical indicator - 6-minute walk test | 24 month | Determination of a significant dependence between the serum concentration of the used medicinal products and the values of the selected clinical indicator - 6-minute walking test. The test measures the distance the patient walks 6 minutes in the corridor (in meters). |
| Clinical indicator - Minnesota Living With Heart Failure Questionnaire | 24 month | Determination of a significant dependence between the serum concentration of the used medicinal products and the values of the selected clinical indicator - Minnesota Living With Heart Failure Questionnaire. The total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. |
| Clinical indicator - Echocardiographic examination | 24 month | Determination of a significant dependence between the serum concentration of the used medicinal products and the values of the selected clinical indicator - echocardiographic examination. |
| Clinical indicator - NT-proBNP concentration | 24 month | Determination of a significant dependence between serum concentration of the used medicinal products and the values of the selected clinical indicator - N-terminal prohormone of natriuretic peptide B (NT-pro BNP), measured in pg/ml. |
| Clinical indicator - The length of survival | 24 month | Determination of a significant dependence between the serum concentration of the used medicinal products and the values of the selected clinical indicator - the length of survival (measured in month). |
| Adverse effects | 24 month | Determination of the number of patients in whom a significant dependence between the serum concentration of the used medicinal products and the adverse effects of these medicinal products is demonstrated. |
| Non-adherence to treatment | 24 month | Determination the number of patients in whom non-adherence to treatment will be demonstrated. |
| Clinical indicator - The hospitalization for HFrEF | 24 month | Determination of a significant dependence between the serum concentration of the used medicinal products and the values of the selected clinical indicator - the hospitalization for HFrEF (yes/no). |
Countries
Czechia
Contacts
Primary ContactJiří Hynčica
Outcome results
None listed