Managing Congestion in Heart Failure: A Mechanistic Study in Patients With HFpEF
Recruiting · NCT06977477 · Interventional (participants receive a specific treatment) · Lead sponsor: Otto-von-Guericke University Magdeburg
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial (MAGIC-HF) is to understand whether daily remote monitoring of pulmonary artery pressure using the CardioMEMS™ device and body water levels using a smart scale can improve the management of congestion in people with heart failure with preserved ejection fraction (HFpEF). Participants who already have an indication for remote monitoring with CardioMEMS™ (A sensor to be implanted in the pulmonary artery in a minimal invasive procedure) will be enrolled. Every day, patients will measure their pulmonary pressure using CardioMEMS and assess the amount of water in different parts of the body, including the arms, legs, and trunk using the scale BWA ON. The measurements will take about 2 minutes each. Over a period of six months, researchers will monitor these measurements along with regular blood tests to observe changes in heart and kidney function by monitoring biomarkers reflecting the function of these organs. Managing fluid buildup (congestion) is a major challenge in people with heart failure, and current methods based on clinical signs are not always reliable. Recent research suggests that congestion in heart failure is not only related to pressure but also to changes in fluid volume, and that better monitoring could help tailor treatments more effectively. By combining pressure and volume data, this study aims to help reach a more balanced fluid state (euvolemia) in participants, which could reduce hospital readmissions and improve overall outcomes. In addition, the study seeks to identify different types, or phenotypes, of congestion based on pressure and volume profiles, which could guide more personalized care in the future. This study is important because it addresses an urgent need to improve the early detection and management of congestion in heart failure. It also explores new approaches that could lead to better understanding and treatment of this complex condition, especially in patients with preserved ejection fraction who often have fewer treatment options.
Who can take part
Inclusion criteria
- 18 years of age or older
- Patients with HFpEF, who are hospitalized for acute decompensated heart failure and require treatment with intravenous (IV) diuretics.
- Signed informed consent.
Exclusion criteria
- Patients admitted with cardiogenic shock and/or those who required inotropic or vasopressor support.
- Had a history of cardiac transplantation or ventricular assist device (VAD) implantation.
- Had any implanted cardiac device (pacemaker, ICD, CRT-D.
- Had chronic kidney disease with creatinine clearance \< 20 ml/min.
- Had recent acute MI or CABG within 3 months.
Where it is running
1 location listed.
- Otto von Guericke University, Faculty of Medicine - Magdeburg, Saxony-Anhalt, Germany