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NCT06977477Recruiting

Managing Congestion in Heart Failure: A Mechanistic Study in Patients With HFpEF

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

Source: ClinicalTrials.gov · Last updated 18 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
9 May 2025
Start date
18 Jun 2024
Primary completion date
15 Dec 2025
Lead sponsor
Otto-von-Guericke University Magdeburg
NCT number
NCT06977477

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 18 Jun 2024 to the primary completion date, 15 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Had a history of cardiac transplantation or ventricular assist device (VAD) implantation.
  • Had any implanted cardiac device (pacemaker, ICD, CRT-D.

Lab values

  • Had chronic kidney disease with creatinine clearance \< 20 ml/min.

Other

  • Patients admitted with cardiogenic shock and/or those who required inotropic or vasopressor support.
  • Had recent acute MI or CABG within 3 months.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Otto von Guericke University, Faculty of Medicine
Coordinator of this site? Confirm its status
MagdeburgGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.