Non-interventional Study on Guideline Directed Medical Therapy for Patients With Heart Failure (HF) in Germany

Launched by ASTRAZENECA · Nov 4, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on improving treatment for patients with heart failure, specifically a type called heart failure with reduced ejection fraction (HFrEF). The study aims to see if a specific training program for doctors can help them start and adjust recommended medication more effectively during and after a hospital stay. The goal is to ensure that patients receive a combination of four important types of heart medications that research shows can help them live healthier lives. This is especially important because many patients currently do not get all the medications they need, which can lead to more hospital visits and worse health outcomes.

To participate in this study, individuals must be at least 18 years old, have been hospitalized for heart failure, and have a specific heart measurement indicating reduced function. They should also be on no more than two of the recommended medication types when they enter the hospital. Participants can expect to receive close monitoring and support from healthcare providers as part of this trial. It’s an important opportunity to help improve heart failure care in real-world settings, ultimately aiming for better health outcomes for many patients.

Gender

ALL

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