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

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.

Conditions

• Heart Failure With Preserved Ejection Fraction
• Remote Monitoring in Heart Failure

Interventions

OTHER

Remote 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

Sponsors & Collaborators

• Otto-von-Guericke University Magdeburg

  lead OTHER

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-18

Primary Completion

2025-12-15

Completion

2026-01-31

Countries

• Germany

Study Locations