RecruitingNot ApplicableNCT06977477

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)


Sponsor

Otto-von-Guericke University Magdeburg

Enrollment

20 participants

Start Date

Jun 18, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how the heart and kidneys work together to cause fluid buildup in people with a type of heart failure called HFpEF (heart failure with preserved ejection fraction — where the heart pumps normally but is too stiff). Researchers want to understand the mechanisms behind fluid overload to improve treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with HFpEF - You are currently in the hospital being treated for worsening heart failure with IV (intravenous) diuretics (water pills given through a drip) **You may NOT be eligible if...** - You are in cardiogenic shock or need medications to support your heart's pumping - You have previously had a heart transplant or a ventricular assist device (heart pump implant) - You have a pacemaker, ICD, or CRT device - You have severe kidney disease (creatinine clearance below 20) - You have had a heart attack or bypass surgery within the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERRemote Monitoring for Congestion Management in HFpEF Patients

All patients will undergo baseline tests, including echocardiography (left ventricular ejection fraction, E/e', left atrial volume index, left atrial strain analysis, left ventricular mass index, tricuspid annular plane systolic excursion, right ventricular strain, inferior vena cava index) and blood tests (NT-proBNP, creatinine, GFR, sST2, CA 125, bio-ADM, ALAT, ASAT, complete blood count, and hsCRP). Evaluation of extracellular and total body water volumes in the arms, legs, and trunk will be conducted using the Body Water Scale InBody (South Korea) and daily monitoring of pulmonary pressure through CardioMEMSTM. Bioelectrical impedance analysis (BIA) will be used to assess volume. Additional blood tests will be conducted at weeks 2, 6, 12, and at the final visit, with a focus on NT-proBNP, creatinine, GFR, ALAT, ASAT, hemoglobin, hematocrit, hsCRP, sST2, CA 125, and bio-ADM. At the final visit, a complete set of tests will be repeated to assess overall health and response to the int


Locations(1)

Otto von Guericke University, Faculty of Medicine

Magdeburg, Saxony-Anhalt, Germany

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NCT06977477


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