Acute Decompensated Heart Failure Clinical Trial
— ADHF-EDOfficial title:
Adherence to Medication in Patients With Acute Decompensated Heart Failure: a Cross-sectional Study at the Emergency Department (ADHF-ED= Adherence to Medication in Patients With Acute Decompensated Heart Failure at the Emergency Department)
NCT number | NCT06459115 |
Other study ID # | ADHF-ED |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2023 |
Est. completion date | December 31, 2024 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Saarland, Saarland University | Homburg |
Lead Sponsor | Collaborator |
---|---|
Universität des Saarlandes |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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." |
1 day (cross-sectional) | |
Secondary | 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) | 1 day (cross-sectional) | |
Secondary | 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) | 1 day (cross-sectional) | |
Secondary | 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) | 1 day (cross-sectional) |
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