Managing Congestion in Heart Failure: Pressure- and Volume- Based. A Mechanistic Study in Patients With HFpEF (MAGIC-HF)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Otto von Guericke University, Faculty of Medicine
RECRUITING
Magdeburg
Contact Information
Primary
Tarek Bekfani, MD, MSc
tarek.bekfani@med.ovgu.de
+49-391-67-14469
Backup
Ruediger Braun-Dullaues, Prof., MD
r.braun-dullaues@med.ovgu.de
+49-391-67-13203
Time Frame
Start Date: 2024-06-18
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 20
Treatments
Other: Patients with HFpEF Remotely Monitored for Congestion and Volume Management
Patients with HFpEF will undergo remote monitoring for congestion management using daily measurements of pulmonary artery pressure via CardioMEMSTM and body water volumes through a smart scale using bioelectrical impedance analysis (BIA). Body water volume will be tracked in different segments (arms, legs, trunk), alongside pulmonary pressure, to explore the mechanisms of congestion and describe its varied phenotypes in HFpEF patients. This intervention aims to optimize fluid balance management and improve clinical outcomes.
Sponsors
Leads: Otto-von-Guericke University Magdeburg

This content was sourced from clinicaltrials.gov