Adherence to Medication in Patients With Acute Decompensated Heart Failure

NCT06459115 | Recruiting

• 1 other identifier: ADHF-ED
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Decompensated Heart Failure

Keywords

Acute Decompensated Heart Failure; Adherence; Emergency department

Outcome Measures

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."

  1 day (cross-sectional)

Secondary Outcomes (3)

• Patients-related factor with impact on adherence (anxiety and depression)

  1 day (cross-sectional)

• Patients-related factors with impact on adherence (social support)

  1 day (cross-sectional)

• Patients-related factor with impact on adherence (dementia)

  1 day (cross-sectional)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with acute decompensated heart failure (AHF) at the emergency department at Saarland University Medical Center

You may qualify if:

• 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)

You may not qualify if:

• \- Not able to give written informed consent

Sponsors & Collaborators

• Universität des Saarlandes: lead

Study Sites (1)

Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Saarland, Saarland University

Homburg, 66421, Germany

RECRUITING

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Felix Mahfoud, Professor

CONTACT

+496841 1615350; Felix.Mahfoud@uks.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 14, 2024
• Study Start: February 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)