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

NCT06977477 | Recruiting

• 1 other identifier: 30/24
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• The Percentage of Patients with Elevated Pulmonary Pressure but Hypo- or Euvolemic and vice versa at 6 Months

  describing the phenotypes of different volume-pressure patterns and the thus better understanding the mechanism of congestion development.

  6 months

• Change from Baseline in GFR (mL/min/1.73m2)

  safety Outcome

  6 months

Secondary Outcomes (1)

• Change from Baseline of NT-proBNP Levels (pg/ml)

  6 months

Study Arms (1)

Patients with HFpEF Remotely Monitored for Congestion and Volume Management

OTHER

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.

Other: Remote Monitoring for Congestion Management in HFpEF Patients

Interventions

Remote Monitoring for Congestion Management in HFpEF Patients OTHER

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

Patients with HFpEF Remotely Monitored for Congestion and Volume Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otto-von-Guericke University Magdeburg: lead

Study Sites (1)

Otto von Guericke University, Faculty of Medicine

Magdeburg, Saxony-Anhalt, 39120, Germany

RECRUITING

Central Study Contacts

Tarek Bekfani, MD, MSc

CONTACT

+49-391-67-14469; tarek.bekfani@med.ovgu.de

Ruediger Braun-Dullaues, Prof., MD

CONTACT

+49-391-67-13203; r.braun-dullaues@med.ovgu.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc (Oxon.), FESC, FHFA

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 18, 2025
• Study Start: June 18, 2024
• Primary Completion: December 15, 2025
• Study Completion: January 31, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

DE (1)