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Use of determination of drug levels to optimize pharmacotherapy of heart failure

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506283-13-00
Enrollment
100
Registered
2023-11-28
Start date
2024-04-09
Completion date
Unknown
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic heart failure with reduced ejection fraction

Brief summary

To determine whether in patients with chronic heart failure with reduced ejection fraction (HFrEF) the serum concentration of the drugs used is more important than the dose of these drugs (beta-blockers bisoprolol, carvedilol, metoprolol succinate or nebivolol; spironolactone, sacubitril, valsartan) for compensating the health status)

Detailed description

To determine the number of patients in whom a significant dependence between the serum concentration of the mentioned drugs and the values of selected clinical indicators (NT-proBNP concentration, 6-minute walk test, quality of life questionnaire, echocardiographic parameters, hospitalization for HFrEF, length of survival) is demonstrated., To determine the number of patients in whom a significant dependence between the serum concentration of the mentioned drugs and the adverse effects of these drugs is demonstrated, To determine the number of patients in whom non-adherence to treatment will be demonstrated

Interventions

DRUGNEBIVOLOL
DRUGCARVEDILOL
DRUGSPIRONOLACTONE
DRUGMETOPROLOL SUCCINATE

Sponsors

Fakultni Nemocnice Ostrava
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
To determine whether in patients with chronic heart failure with reduced ejection fraction (HFrEF) the serum concentration of the drugs used is more important than the dose of these drugs (beta-blockers bisoprolol, carvedilol, metoprolol succinate or nebivolol; spironolactone, sacubitril, valsartan) for compensating the health status)

Secondary

MeasureTime frame
To determine the number of patients in whom a significant dependence between the serum concentration of the mentioned drugs and the values of selected clinical indicators (NT-proBNP concentration, 6-minute walk test, quality of life questionnaire, echocardiographic parameters, hospitalization for HFrEF, length of survival) is demonstrated., To determine the number of patients in whom a significant dependence between the serum concentration of the mentioned drugs and the adverse effects of these drugs is demonstrated, To determine the number of patients in whom non-adherence to treatment will be demonstrated

Countries

Czechia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026