Real-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany

Launched by ASTRAZENECA · Mar 22, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a medication called dapagliflozin is used in patients with heart failure in Germany. Heart failure is a serious condition that affects many people, and despite new treatments, it can still greatly impact a person's quality of life. Dapagliflozin has recently been approved for treating heart failure, even in patients who don’t have diabetes. The study aims to gather information on how well this medication works in real-life situations, including its effects on heart failure symptoms, daily activities, and overall health.

To participate in the trial, you need to be at least 18 years old and have started taking dapagliflozin for heart failure within the last 14 to 90 days. You should have one of three types of heart failure, which are based on how well your heart pumps blood. Participants will need to sign a consent form and will be monitored to see how the medication affects their health and daily lives. This study is important because it will help doctors understand how dapagliflozin works in everyday patients and improve care for those with heart failure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years as of study index date; the study index date is date of initiation of treatment with dapagliflozin
• * Patient received/receiving treatment with dapagliflozin in accordance with the local dapagliflozin product label for symptomatic chronic heart failure (HF) and at timepoint of dapagliflozin initiation with:
• • preserved ejection fraction (HFpEF; EF≥50%) OR mildly reduced ejection fraction (HFmrEF; EF 41-49%)
• • OR reduced ejection fraction (HFrEF EF ≤40%)
• • Patient is enrolled within 14 to 90 days following initiation of dapagliflozin
• • Signed and dated informed consent prior to enrolment in the study
• Exclusion Criteria:
• • Patient should not be enrolled if he/she is less than 14 days or more than 90 days following initiation of dapagliflozin
• • Prior treatment with dapagliflozin or other SGLT2i treatment
• • Initiation of dapagliflozin outside of the local HF label
• • Diagnosis of Type 1 diabetes prior to enrolment
• • Current or planned participation in a clinical trial using an investigational medical product for treating HF
• • Patient is involved in the planning and/or conduction of the study
• • Hypersensitivity to dapagliflozin or to any of the excipients listed in the SmPC