Adherence to Medication in Patients With Acute Decompensated Heart Failure

Last updated: June 17, 2024
Sponsor: Universität des Saarlandes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Heart Failure

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT06459115
ADHF-ED
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age ≥18 years of age

  • known chronic heart failure irrespective of ejection fraction (heart failure withreduced, 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, pulmonaryrales, 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

Exclusion Criteria:

  • Not able to give written informed consent

Study Design

Total Participants: 100
Study Start date:
February 01, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

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

    Homburg, 66421
    Germany

    Active - Recruiting

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