NCT06675552 Non-interventional Study on Guideline Directed Medical Therapy for Patients With Heart Failure (HF) in Germany
| NCT ID | NCT06675552 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Heart Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 438 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 438 participants in total. It began in 2024-11-15 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Heart failure (HF) is a global public health issue that affects more than 63 million people worldwide. The clinical and economic burden of HF on health care systems is substantial. Heart failure with reduced ejection fraction (HFrEF) represents approximately 50% of the HF patient population.The burden of HF is expected to increase substantially as the population ages, and despite improvements in treatment, hospitalisation and mortality rates remain especially high in HFrEF patients. The current guideline recommendation of directed medical therapy for HFrEF combines four drug classes with proven prognostic benefit: Angiotensin receptor-neprilysin inhibitor (ARNI)/angiotensin converting enzyme inhibitors (ACE I)/angiotensin receptor blockers (ARB), betablockers (BB), mineralocorticoid receptor antagonists (MRA), and sodium-glucose co-transporter 2 inhibitors (SGLT2i). The 2023 ESC (European Society of Cardiology) HF guideline update additionally recommends a rapid in-hospital sequencing approach of guideline-directed medical therapy (GDMT) with frequent physician visits during the first 6 weeks post discharge. Studies investigating the implementation of GDMT in a real-world setting have shown that a significant proportion of patients did not receive the recommended drug combination therapy. Delayed initiation of GDMT contributes to the low number of patients receiving guideline concordant HFrEF therapy, which ultimately may affect patient outcomes. One approach to implement the 2023 ESC guideline updates for heart failure treatment regarding early in-hospital initiation and rapid up-titration of GDMT could be to provide specific training on GDMT recommendations. Such a standardised training is offered to the physicians treating HF patients within selected hospitals of the German Helios hospital network (Helios-GDMT-program). Evidence is needed in order to assess whether in-hospital initiation and up-titration of all phenotype concordant classes of GDMT at hospital discharge can be observed after standardised physician training and whether the GDMT-program implementation also translates into real-world routine outpatient care with respect to use of GDMT and clinical outcomes.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06675552 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 130 Years, studying Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06675552 currently recruiting?
Yes, NCT06675552 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT06675552 trial being conducted?
This trial is being conducted at Berlin, Germany, Erfurt, Germany, Gifhorn, Germany, Leipzig, Germany and 2 additional locations.
Who is sponsoring the NCT06675552 clinical trial?
NCT06675552 is sponsored by AstraZeneca. The trial plans to enroll 438 participants.