Registry for patients with heart failure, coronary artery disease, and atrial fibrillation
The Helios Heart Registry: A Standardized Registry for Capturing Clinical and Patient-reported Outcomes in Patients With Specific Cardiac Diseases: Application of the ICHOM Standard in Clinical Practice
This study is collecting information from patients with heart failure, coronary artery disease, and atrial fibrillation to see how they are being treated and how well those treatments are working in real life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helios Health Institute GmbH Academic / other |
| Locations | 10 sites (Berlin and 9 other locations) |
| Trial ID | NCT04844944 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to evaluate the current treatment practices for heart failure, coronary artery disease, and atrial fibrillation using a standardized set of variables and outcome measures. It will collect data from patients diagnosed with these conditions to monitor healthcare utilization and treatment interactions in a real-world setting. The registry is based on recommendations from the International Consortium for Health Outcomes Measurement (ICHOM) to ensure objective assessment of disease progression and patient-oriented outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are hospitalized with a diagnosis of heart failure, coronary artery disease, or atrial fibrillation.
Not a fit: Patients who are unable to provide informed consent or those with severe conditions such as cardiogenic shock or who have undergone heart transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness of current treatments for cardiovascular diseases, leading to improved patient care.
How similar studies have performed: Other studies utilizing standardized registries for cardiovascular diseases have shown promise in improving treatment outcomes, indicating that this approach is both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age of 18 years or older * Inpatient Treatment * Present diagnosis of at least one of the three cardiovascular disease entities of interest according to the current guidelines of the European Society of Cardiology (ESC): HF, CAD, AF Exclusion Criteria: * Inability to provide informed consent * Initial presentation (index hospitalization) in cardiogenic shock or other kinds of shock * Patient after heart transplantation or patient with present ventricular assist device (VAD)
Where this trial is running
Berlin and 9 other locations
- Helios Klinikum Berlin-Buch — Berlin, Germany (Active_not_recruiting)
- Helios Klinikum Erfurt — Erfurt, Germany (Active_not_recruiting)
- Helios Klinikum Gifhorn — Gifhorn, Germany (Active_not_recruiting)
- Helios Klinikum Hildesheim — Hildesheim, Germany (Recruiting)
- Heart Center Leipzig at University of Leipzig — Leipzig, Germany (Active_not_recruiting)
- Helios Vogtlandklinikum Plauen — Plauen, Germany (Active_not_recruiting)
- Helios Klinikum Schwerin — Schwerin, Germany (Recruiting)
- Helios Klinikum Siegburg — Siegburg, Germany (Active_not_recruiting)
- Helios Dr. Horst Schmidt Kliniken Wiesbaden — Wiesbaden, Germany (Recruiting)
- Helios Universitätsklinikum Wuppertal — Wuppertal, Germany (Recruiting)
Study contacts
- Study coordinator: Andreas Bollmann, MD, PhD
- Email: Andreas.bollmann@helios-gesundheit.de
- Phone: +49 341 865-1413
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.