Adherence to Medication in Patients With Acute Decompensated Heart Failure
ConditionAcute Decompensated Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversität des Saarlandes
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Patients presenting with acute decompensated heart failure (AHF) at the emergency department at Saarland University Medical Center
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Adherence to heart failure medication
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 Two different definitions of adherence are used: * 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. * A 80% threshold is used. If \>80% of the prescribed heart failure drugs were detectable in urine, the patient was characterized as "adherent." Otherwise, the patient was considered to be "nonadherent."
Time frame
1 day (cross-sectional)Secondary outcomes
1
Patients-related factor with impact on adherence (anxiety and depression)
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)
Time frame
1 day (cross-sectional)2
Patients-related factors with impact on adherence (social support)
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)
Time frame
1 day (cross-sectional)3
Patients-related factor with impact on adherence (dementia)
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)
Time frame
1 day (cross-sectional)Sponsors and contacts
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Source ClinicalTrials.gov