Clinical trial NCT06459115: Adherence to Medication in Patients With Acute Decompensated Heart Failure
Official 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Decompensated Heart Failure
Keywords: Acute Decompensated Heart Failure
Adherence
Emergency department
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with acute decompensated heart failure (AHF) at the emergency department at Saarland University Medical Center

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to heart failure medication
timeFrame: 1 day (cross-sectional)
Secondary outcomes:
measure: Patients-related factor with impact on adherence (anxiety and depression)
timeFrame: 1 day (cross-sectional)
measure: Patients-related factors with impact on adherence (social support)
timeFrame: 1 day (cross-sectional)
measure: Patients-related factor with impact on adherence (dementia)
timeFrame: 1 day (cross-sectional)
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Saarland, Saarland University
Study officials:
References: