Heart Failure With Preserved Ejection FractionMAGIC-HFNCT06977477
Managing Congestion in Heart Failure: A Mechanistic Study in Patients With HFpEF
A study testing Remote Monitoring for Congestion Management in HFpEF Patients in people with Heart Failure With Preserved Ejection Fraction and Remote Monitoring in Heart Failure, run by Otto-von-Guericke University Magdeburg at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Remote Monitoring in Heart Failure
- What is being tested?
- Remote Monitoring for Congestion Management in HFpEF Patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jun 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Otto von Guericke University, Faculty of Medicine
Magdeburg, Saxony-Anhalt, 39120
About this study
Official title: Managing Congestion in Heart Failure: Pressure- and Volume- Based. A Mechanistic Study in Patients With HFpEF (MAGIC-HF)
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.
Read the detailed description
Heart failure with preserved ejection fraction (HFpEF) remains a major clinical challenge, with high hospitalization and readmission rates that contribute to substantial healthcare costs. Achieving and maintaining euvolemia is a key goal in the management of heart failure (HF), but current methods of monitoring congestion are suboptimal. Clinical signs and symptoms often occur late and are neither sensitive nor specific for detecting early decompensation. Furthermore, traditional reliance on pressure measurements alone, such as pulmonary artery pressures, has been questioned, since elevated pressure may coexist with euvolemia or hypovolemia.
The MAGIC-HF study is a prospective, mechanistic, multi centre, remote monitoring (RM) study aiming to explore the combined use of pressure- and volume-based monitoring to improve congestion management in patients with HFpEF and to better understand the relation pressure-volume in this group of patients. This study will evaluate the daily measurements of pulmonary artery pressure, collected via the CardioMEMS™ device, in conjunction with extracellular and total body water assessments obtained through a segmental bioelectrical impedance smart scale (BWA device).
Participants enrolled in the study will have an indication for CardioMEMS™ monitoring and will undergo continuous daily assessments over a 6-month follow-up period. These measurements will focus on changes in pulmonary pressure and body fluid distribution across upper extremities, lower extremities, and trunk compartments. The hypothesis is that combining pressure and volume data will allow better detection and management of congestion, reaching a euvolemic state more effectively, and ultimately improving important biomarkers such as NT-proBNP and renal function.
Baseline evaluations will include a comprehensive echocardiographic assessment: laboratory analyses (NT-proBNP, creatinine, GFR, sST2, CA-125, bio-ADM, ALAT, ASAT, complete blood count, hsCRP). Daily remote monitoring will involve CardioMEMS™ pressure recordings and smart scale assessments. Additional blood tests will be collected at days 14, 42, 90, and at the final visit.
The study aims to characterize different congestion phenotypes based on pressure-volume relationships, such as elevated pressure with hypervolemia, euvolemia, or hypovolemia. Understanding these subgroups may allow tailored management strategies. This could challenge current treatment paradigms, particularly the routine use of diuretics based solely on pressure readings.
The primary focus will be an exploratory analysis of changes in NT-proBNP levels, glomerular filtration rate (GFR), and the proportion of participants presenting with discordant pressure and volume statuses. NT-proBNP will be adjusted for BMI following formulas used in previous trials like GUIDE-HF.
Overall, MAGIC-HF seeks to expand knowledge of congestion mechanisms in HFpEF, inform clinical practice about more precise management of congestion, and potentially lead to improved clinical outcomes through more individualized and physiologically guided therapy.
- Being tested
- Remote Monitoring for Congestion Management in HFpEF Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Monitoring for Congestion Management in HFpEF PatientsOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Remote Monitoring for Congestion Management in HFpEF Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Change from Baseline in GFR (mL/min/1.73m2)
safety Outcome
Measured: 6 months
Secondary outcomes (1)
Change from Baseline of NT-proBNP Levels (pg/ml)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start18 Jun 2024
- Primary completion15 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otto-von-Guericke University Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Bekfani, Otto-von-Guericke University Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977477
- Sponsor's protocol ID
- 30/24
- Acronym
- MAGIC-HF
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Congestion in Heart Failure: Pressure- and Volume- Based. A Mechanistic Study in Patients With HFpEF (MAGIC-HF)
- ClinicalTrials.gov ID
- NCT06977477
- Acronym / sponsor ID
- MAGIC-HF / 30/24
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Otto-von-Guericke University MagdeburgUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Heart failure with preserved ejection fraction (HFpEF) remains a major clinical challenge, with high hospitalization and readmission rates that contribute to substantial healthcare costs. Achieving and maintaining euvolemia is a key goal in the management of heart failure (HF), but current methods of monitoring congestion are suboptimal. Clinical signs and symptoms often occur late and are neither sensitive nor specific for detecting early decompensation. Furthermore, traditional reliance on pressure measurements alone, such as pulmonary artery pressures, has been questioned, since elevated pressure may coexist with euvolemia or hypovolemia.
The MAGIC-HF study is a prospective, mechanistic, multi centre, remote monitoring (RM) study aiming to explore the combined use of pressure- and volume-based monitoring to improve congestion management in patients with HFpEF and to better understand the relation pressure-volume in this group of patients. This study will evaluate the daily measurements of pulmonary artery pressure, collected via the CardioMEMS™ device, in conjunction with extracellular and total body water assessments obtained through a segmental bioelectrical impedance smart scale (BWA device).
Participants enrolled in the study will have an indication for CardioMEMS™ monitoring and will undergo continuous daily assessments over a 6-month follow-up period. These measurements will focus on changes in pulmonary pressure and body fluid distribution across upper extremities, lower extremities, and trunk compartments. The hypothesis is that combining pressure and volume data will allow better detection and management of congestion, reaching a euvolemic state more effectively, and ultimately improving important biomarkers such as NT-proBNP and renal function.
Baseline evaluations will include a comprehensive echocardiographic assessment: laboratory analyses (NT-proBNP, creatinine, GFR, sST2, CA-125, bio-ADM, ALAT, ASAT, complete blood count, hsCRP). Daily remote monitoring will involve CardioMEMS™ pressure recordings and smart scale assessments. Additional blood tests will be collected at days 14, 42, 90, and at the final visit.
The study aims to characterize different congestion phenotypes based on pressure-volume relationships, such as elevated pressure with hypervolemia, euvolemia, or hypovolemia. Understanding these subgroups may allow tailored management strategies. This could challenge current treatment paradigms, particularly the routine use of diuretics based solely on pressure readings.
The primary focus will be an exploratory analysis of changes in NT-proBNP levels, glomerular filtration rate (GFR), and the proportion of participants presenting with discordant pressure and volume statuses. NT-proBNP will be adjusted for BMI following formulas used in previous trials like GUIDE-HF.
Overall, MAGIC-HF seeks to expand knowledge of congestion mechanisms in HFpEF, inform clinical practice about more precise management of congestion, and potentially lead to improved clinical outcomes through more individualized and physiologically guided therapy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HFpEF Remotely Monitored for Congestion and Volume Management | Other | Other: Remote Monitoring for Congestion Management in HFpEF PatientsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Monitoring for Congestion Management in HFpEF PatientsAll 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 | Other | Patients with HFpEF Remotely Monitored for Congestion and Volume Management |
Primary outcome
The Percentage of Patients with Elevated Pulmonary Pressure but Hypo- or Euvolemic and vice versa at 6 Months
Time frame: 6 months
describing the phenotypes of different volume-pressure patterns and the thus better understanding the mechanism of congestion development.
Change from Baseline in GFR (mL/min/1.73m2)
Time frame: 6 months
safety Outcome
1 secondary outcome
Change from Baseline of NT-proBNP Levels (pg/ml)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Monitoring for Congestion Management in HFpEF Patients in people with Heart Failure With Preserved Ejection Fraction and Remote Monitoring in Heart Failure, run by Otto-von-Guericke University Magdeburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tarek Bekfani, MD, MSc (+49-391-67-14469, tarek.bekfani@med.ovgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of Patients with Elevated Pulmonary Pressure but Hypo- or Euvolemic and vice versa at 6 Months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.