Adherence to Medication in Patients With Acute Decompensated Heart Failure

Acute Decompensated Heart Failure Clinical Trial

— ADHF-ED  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459115
• Other study ID #: ADHF-ED
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Universität des Saarlandes
• Contact: Felix Mahfoud, Professor
• Phone: +496841 1615350
• Email: Felix.Mahfoud[@]uks.eu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Locations

Country	Name	City	State
Germany	Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Saarland, Saarland University	Homburg

Sponsors (1)

Lead Sponsor	Collaborator
Universität des Saarlandes

Country where clinical trial is conducted

Germany, 

Outcome

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)