Adherence to Medication in Patients With Acute Decompensated Heart Failure

NCT ID: NCT06459115

Last Updated: 2024-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Acute Decompensated Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universität des Saarlandes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Homburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Felix Mahfoud, Professor

Role: CONTACT

+496841 1615350

Facility Contacts

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Felix Mahfoud, Professor

Role: primary

+4968411615350

Other Identifiers

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ADHF-ED

Identifier Type: -

Identifier Source: org_study_id

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