Acute Decompensated Heart Failure
Conditions
Keywords
Acute Decompensated Heart Failure, Adherence, Emergency department
Brief summary
Every day, patients present to emergency department due to acute heart failure. There are many causes for decompensation. One possible cause is a lack of adherence to heart failure medication (prognosis-improving medications and diuretics). The aim of this study is to directly measure adherence in patients with acute heart failure (gold standard of adherence measurement using liquid chromatography coupled to high-resolution mass spectrometry= LC-HRMS/MS) at the emergency department. Questionnaires are used to investigate possible factors influencing adherence.
Detailed description
Several drugs has been shown to improve survival and to reduce the risk for hospitalization for acute heart failure (AHF) in patients with chronic heart failure. Despite optimal drug treatment, patients with heart failure suffer one hospitalization for AHF every year on average with the requirement of intravenous diuretics. Hence, AHF is one of the leading causes for emergency department visits in elderly patients. A possible cause for AHF in patients with known heart failure is nonadherence to drug treatment. Long-term-adherence to drugs of chronic diseases is low. Direct methods to assess adherence like the measurement drug levels or metabolites in body fluids are considered as the gold standard. This study aimed to i) provide (direct measured) adherence rates of patients presented with AHF to the emergency department and ii) to identify patient-related factors with impact on adherence.
Interventions
None listed
Sponsors
Universität des Saarlandes
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥18 years of age * known chronic heart failure irrespective of ejection fraction (heart failure with reduced, mildly reduced, or preserved ejection fraction) * requirement of intravenous diuretics (outpatient or stationary treatment) * stable heart failure medication \>2 weeks * ≥1 sign of volume overload (peripheral edema, jugular venous distension, pulmonary rales, ascites, or demonstration of pulmonary venous congestion on chest X-ray) * elevated natriuretic peptides (N-terminal pro brain natriuretic peptide= nt-pro-BNP ≥125 pg/ml)
Exclusion criteria
\- Not able to give written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to heart failure medication | 1 day (cross-sectional) | Directly measured adherence rates (measurement of drug levels or metabolites in body fluids via toxicological analysis) of patients with acute heart failure at the emergency department \- If all prescribed drugs/metabolites for the treatment of heart failure were detectable in urine, the patient is "adherend". If 1 or at least 2 prescribed drugs were nondetectable in urine, the patient was classified as "partially adherend" and "non-adherend", respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients-related factor with impact on adherence (anxiety and depression) | 1 day (cross-sectional) | Measurement of anxiety and depressions via one questionnaire with two subscales (Hospital Anxiety and Depression Scale- German version= HADS-D; Two subscales HADS-A (anxiety) and HADS-D (depression), each with 7 items; this results in two total scores for the HADS-A (anxiety) and HADS-D (depression) scales with value ranges from 0 - 21; higher values indicating depression or anxiety; 0-7 unremarkable, 8-10 suspicious, \>10 conspicuous) |
| Patients-related factors with impact on adherence (social support) | 1 day (cross-sectional) | Measurement of social support via one questionnaire (ENRICHD Social Support Instrument German version= ESSI-D; 5 items; total score 5-25; higher values indicating better social support) |
| Patients-related factor with impact on adherence (dementia) | 1 day (cross-sectional) | Measurement of dementia via one questionnaire (Demtect; Total score= 0-18; 0-8= Suspected dementia; 9-12= Mild cognitive impairment; 13-18= Cognitive powers appropriate for subject's age) |
Countries
Germany
Outcome results
None listed