RecruitingNAINTERVENTIONAL

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

The MAGIC-HF study is looking into new ways to manage fluid buildup (congestion) in people with a specific type of heart failure called Heart Failure with Preserved Ejection Fraction (HFpEF). Current methods for tracking fluid aren’t always accurate, so this study is exploring if daily monitoring using special devices can help. Participants who already have a small sensor called CardioMEMS™ implanted in their heart artery will also use a smart scale to measure their body's water levels. The aim is to see if combining these measurements can help doctors better balance fluid in the body, which could lead to fewer hospital visits and better overall health for people with HFpEF. This research is important because it could lead to more personalised and effective ways to treat this challenging condition.

At a glance

Status

Recruiting

Phase

Sponsor

Otto-von-Guericke University Magdeburg

Enrolment target

Start

18 Jun 2024

Estimated completion

31 Jan 2026

Heart Failure With Preserved Ejection Fraction Remote Monitoring in Heart Failure

What is this study about?

Heart failure means your heart isn't pumping blood as well as it should. In Heart Failure with Preserved Ejection Fraction (HFpEF), your heart can still pump blood out well, but its chambers are stiff and don't fill properly. A common problem for people with heart failure is fluid building up in their body, called congestion. This can make you feel breathless and tired, and often leads to hospital stays. Doctors currently use signs like swelling or breathlessness to check for fluid buildup, but these don't always show the problem early enough.

The MAGIC-HF study wants to see if using two types of daily monitoring can help manage this fluid buildup better. The first is a small sensor called CardioMEMS™, which is already implanted in some patients and measures pressure in a lung artery. The second is a special smart scale that measures how much water is in different parts of your body, like your arms and legs. By looking at both the pressure and the water levels every day, researchers hope to get a much clearer picture of what's happening inside your body.

The main goal is to figure out if combining these measurements helps doctors keep your body's fluid levels balanced, which is called 'euvolemia'. Achieving this balance could mean fewer trips to the hospital and an improvement in your overall health. The study also aims to understand if there are different types of fluid buildup in HFpEF patients, depending on their pressure and water levels. This could help doctors offer more tailored and effective treatments in the future for this specific type of heart failure, where treatment options are currently limited.

Key takeaways

This study is for people with a type of heart failure called HFpEF.
It tests if daily monitoring of heart pressure and body water can improve fluid management.
Participants must already have a CardioMEMS™ sensor and use a smart scale daily.
The goal is to reduce hospital stays and improve health by better balancing body fluids.
Participation involves 6 months of daily measurements and occasional blood tests.
This research hopes to lead to more personalised heart failure treatment.

Who may be eligible?

To join this study, you need to be 18 years old or older and have a diagnosis of Heart Failure with Preserved Ejection Fraction (HFpEF). You must have recently been in hospital because your heart failure worsened and required treatment with special water pills given through a vein (intravenous diuretics). Importantly, you also need to already have a CardioMEMS™ device, which is a small sensor placed in a blood vessel near your lungs, as this study uses daily readings from it. You'll also need to sign an informed consent form, showing you understand and agree to take part.

There are also some reasons why you wouldn't be able to join. For example, if you were admitted to hospital with a very severe form of heart failure called cardiogenic shock, or if you needed medications to help your heart pump stronger or raise your blood pressure. You also can't participate if you've had a heart transplant, a mechanical helper for your heart (ventricular assist device), or any other implanted heart device like a pacemaker or defibrillator. Severe kidney disease (specifically, if your creatinine clearance is less than 20 ml/min) or having had a recent heart attack or major heart bypass surgery within the last three months would also mean you couldn't take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have Heart Failure with Preserved Ejection Fraction (HFpEF)?
Have you recently been in hospital for worsening heart failure needing intravenous diuretics?
Do you already have a CardioMEMS™ device implanted?
Do you NOT have a pacemaker, defibrillator, or other implanted heart device?
Do you NOT have severe kidney disease (creatinine clearance less than 20 ml/min)?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be involved for six months. Every day, you'll need to use your CardioMEMS™ device to measure your pulmonary artery pressure. You'll also step onto a special smart scale (BWA ON) that measures the amount of water in different parts of your body, such as your arms, legs, and middle section. Each of these daily measurements should only take about two minutes. Throughout the six months, researchers will collect these daily readings, along with regular blood tests to check how your heart and kidneys are working. There are no study medications involved; your current heart failure treatment will continue as normal, and the study will monitor how your body responds to ongoing care while using the new monitoring methods.

Potential risks and benefits

Participating in this study might offer a potential benefit by providing your healthcare team with more detailed daily information about your heart pressure and body fluid levels. This could help them adjust your treatment more precisely to keep your fluid balanced, potentially reducing the chance of your heart failure worsening or needing hospital visits. However, it's important to know that this is a research study, and there's no guarantee of direct personal benefit. There are no known additional risks from the study itself beyond what's involved in your routine care and having the CardioMEMS device, which you already have. For example, the daily measurements are simple and non-invasive. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Otto von Guericke University, Faculty of Medicine
Verified postcode
Magdeburg, Germany· Recruiting

Common questions

What is HFpEF?

HFpEF is a type of heart failure where your heart muscle is stiff, meaning it doesn't relax properly to fill with blood, even though it can still pump blood out well.

What is congestion in heart failure?

Congestion means there's too much fluid building up in your body, often in your lungs, legs, or belly, making you feel short of breath or swollen.

What is CardioMEMS™?

CardioMEMS™ is a small sensor already implanted in some patients that measures pressure in an artery near your lungs. This helps doctors keep an eye on your heart failure.

How long will I be in the study?

If you join, you will be part of the study for six months, taking daily measurements and having regular check-ups.

Will I take new medication in this study?

No, this study does not involve new medications. It focuses on using daily monitoring devices to help manage your existing heart failure treatment.

How to find out more

Tarek Bekfani, MD, MSc

tarek.bekfani@med.ovgu.de +49-391-67-14469 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.