Observational study on heart failure treatment in Germany
PHenotype-based RApid SEquencing of Guideline-directed Medical Therapy for Heart Failure With Reduced Ejection Fraction (PHRASE-HF): A Multicentre, Prospective, Non-interventional Study to Examine Outcomes of Rapid In-hospital Implementation of GDMT and Its Translation From Discharge Into Routine Care
This study looks at how well heart failure treatments are used for patients in Germany when they leave the hospital and how these treatments affect their recovery and overall health afterwards.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 438 (estimated) |
| Ages | 18 Years to 130 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 6 sites (Berlin and 5 other locations) |
| Trial ID | NCT06675552 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF) who are hospitalized in Germany. It aims to assess the implementation of GDMT at hospital discharge and its translation into outpatient care, focusing on patient-reported outcomes and clinically relevant outcomes such as rehospitalization and mortality. The study will analyze data from patients treated with specific drug classes during their hospital stay, providing insights into real-world treatment practices.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been hospitalized for heart failure with reduced ejection fraction and are receiving guideline-directed medical therapy.
Not a fit: Patients who are in cardiogenic shock, have undergone heart transplantation, or have a history of intolerance to the required medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and outcomes of heart failure patients by optimizing treatment strategies based on real-world evidence.
How similar studies have performed: Other studies have shown success in evaluating guideline-directed therapies for heart failure, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years at the time of signing the informed consent * Hospitalised in a participating site and receiving full inpatient treatment (at least 24h hospital stay) * Diagnosis of HFrEF according to the current guidelines of the European Society of Cardiology (ESC) with a left ventricular EF of ≤40% (as measured per echocardiography during the index hospital stay or within 3 months prior to index hospitalisation with available reports from imaging (ejection fraction) at the time of study inclusion) * Treated with a maximum of 2 of the indicated drug classes (ACE-I/ARNI/ARB, BB, MRA, SGLT2i) according to guideline recommendation (GDMT) at admission. * Signed and dated written informed consent prior to enrolment in the study * Willing and capable to fulfil requirements listed in the ICF Exclusion Criteria: * Initial presentation (index hospitalisation) in cardiogenic shock or other kinds of shock * Status post heart transplantation * History of intolerance to one or more GDMT drug classes (ACE-I/ARNI/ARB, BB, MRA, SGLT2i) or significant side effects that led to the discontinuation of two or more substances within one drug class (except from ACE-I/ARB, e.g., if 2 different ACE inhibitors triggered cough, but sartans are tolerated, then the patient is not excluded) * Current or planned participation in a clinical trial * Decision by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures * Pregnancy or breast-feeding
Where this trial is running
Berlin and 5 other locations
- Research Site — Berlin, Germany (Recruiting)
- Research Site — Erfurt, Germany (Recruiting)
- Research Site — Gifhorn, Germany (Recruiting)
- Research Site — Leipzig, Germany (Recruiting)
- Research Site — Schwerin, Germany (Recruiting)
- Research Site — Wuppertal, Germany (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
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.