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Acute Decompensated Heart FailureADHF-EDNCT06459115

Adherence to Medication in Patients With Acute Decompensated Heart Failure

An observational study of Acute Decompensated Heart Failure, run by Universität des Saarlandes at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Decompensated Heart Failure
How many people
100 participants
Where
1 siteGermany
Study dates
1 Feb 2023to 1 Oct 2024
How long will I take part?
7 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

  • Not able to give written informed consent

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Homburg, 66421

Other trials in Germany

About this study

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)

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.

Read the 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.

Keywords
Acute Decompensated Heart Failure, Adherence, Emergency department
Medical subject headings
Emergencies

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    • 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.

    Measured: 1 day (cross-sectional)

Secondary outcomes (3)

  1. 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)

    Measured: 1 day (cross-sectional)

  2. 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)

    Measured: 1 day (cross-sectional)

  3. 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)

    Measured: 1 day (cross-sectional)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2024
  2. Study start1 Feb 2023
  3. Primary completion1 May 2024
  4. Study completion1 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
100 participants (actual)
Target duration
7 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06459115
Sponsor's protocol ID
ADHF-ED
Acronym
ADHF-ED
Status last verified
Jul 2026
First submitted
10 Jun 2024
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kunz M, Schaar JM, Welker KR, Lauder L, Gotzinger F, Kindermann I, Schulz M, Bohm M, Meyer MR, Mahfoud F. Medication adherence in patients with acutely decompensated heart failure: A cross-sectional study in the emergency department (ADHF-ED). Eur J Heart Fail. 2025 Dec;27(12):2763-2772. doi: 10.1002/ejhf.3756. Epub 2025 Jul 10.

    PubMed 40637306

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Decompensated Heart Failure, run by Universität des Saarlandes at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to heart failure medication (time frame: 1 day (cross-sectional)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06459115, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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