RecruitingNAINTERVENTIONAL

The DAPA-MEMRI Trial

The DAPA-MEMRI trial wants to understand how a medicine called dapagliflozin (known as Farxiga) helps people with heart failure. We know this drug can improve heart failure, but we don't fully understand why. The study will look at how calcium behaves in the heart muscle, as problems with calcium are often seen in heart failure. We'll use a new kind of heart MRI scan with a special 'dye' to see these changes. Participants will include people with heart failure (with or without diabetes), people with diabetes but without heart failure, and healthy volunteers. The aim is to find out if dapagliflozin helps improve heart function by affecting how calcium works, which could lead to better treatments for heart failure.

At a glance

Status

Recruiting

Phase

Sponsor

University of Edinburgh

Enrolment target

160

Start

19 Aug 2020

Estimated completion

28 Jul 2028

Heart Failure Diabetic Cardiomyopathies

What is this study about?

Heart failure is a serious condition where your heart can't pump blood around your body as well as it should. Many people with diabetes are at a higher risk of developing heart failure, and we often see changes in their heart muscle, like scarring and thickening. One important process in how your heart beats is the movement of calcium within the heart muscle cells. Early problems in heart failure can involve changes in how this calcium works.

Recently, a type of medicine called SGLT2 inhibitors (like dapagliflozin, also known as Farxiga) has been shown to help people with heart failure, even if they don't have diabetes. However, doctors don't yet fully understand exactly how these medicines work to help the heart. This study aims to find out if these drugs improve heart function by affecting the way calcium is handled in the heart muscle.

To do this, we'll be using a special type of heart scan called an MRI, along with a new 'dye' that contains manganese. This new dye can help us see in great detail not only the structure of the heart but also how well it's working and how calcium is behaving within the heart muscle. By understanding these tiny changes, we hope to learn more about how dapagliflozin helps the heart and eventually tailor treatments more effectively for people with heart failure.

Key takeaways

This study investigates how dapagliflozin helps heart failure patients.
It uses special MRI scans with a new dye to look at heart muscle changes.
Study includes people with heart failure, diabetes, and healthy volunteers.
Some participants will take either real drug or a dummy pill for six months.
Aims to understand how calcium works in the heart and lead to better treatments.

Who may be eligible?

This study is looking for a few different groups of people. We need people who have heart failure, whether they also have type 2 diabetes or not. We also need people who have type 2 diabetes but do not have heart failure. Finally, we're looking for healthy volunteers who don't have any major health conditions.

For those with heart failure, you would need to be over 18 years old and have been diagnosed with a certain type of heart failure for at least two months. There are also specific levels your blood tests would need to show. If you have type 2 diabetes, you would also need to be over 18 and have had your diabetes diagnosis for at least 12 months, and it should be well-managed.

There are also reasons you might not be able to join. For example, if you're already taking an SGLT2 inhibitor drug, have severe kidney problems, very low blood pressure, or have recently been in hospital for a heart problem. We also can't include people with certain types of heart conditions or those who can't have an MRI scan.

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 over 18 years old?
Do you have heart failure OR type 2 diabetes, OR are you a healthy volunteer?
Are you NOT currently taking an SGLT2 inhibitor (like Farxiga or Jardiance)?
Are you able to have an MRI scan?
Are you not currently experiencing severe kidney problems?

Answer every question to see your result.

What does participation involve?

This study has two main parts. First, we'll compare different groups of people.

If you take part, you'll first have a meeting where we'll explain everything and get your consent. You'll then have a medical check-up, blood tests, an ECG (heart tracing), and an echocardiogram (an ultrasound of your heart). Most importantly, you will have two MRI scans of your heart. One will be a standard MRI scan with a contrasting 'dye', and the other will be a special Manganese-enhanced MRI (MEMRI) scan which takes about 45-60 minutes. You'll be monitored during the scan, and we can offer anti-sickness medicine if needed.

For some people with heart failure, after this initial stage, you might be invited to the second part of the study. This is a "randomised controlled trial." This means you'd be randomly assigned to take either dapagliflozin 10mg or a dummy pill (placebo) once a day for six months. Neither you nor your study doctor would know which one you are taking. Throughout this time, you would have regular clinical assessments, blood tests, heart tracings, echocardiograms, and MRI scans to see how your heart is responding. The total duration of participation would depend on which part of the study you participate in.

Potential risks and benefits

Potential benefits of taking part include helping us understand heart failure better, which could lead to improved treatments for many people in the future. If you are in the treatment group, you might also directly benefit from the study drug. Potential risks include discomfort from blood tests and MRI scans, and some people may feel sick after the special MRI dye. As with any drug, dapagliflozin has potential side effects, and these will be fully explained. You also have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Edinburgh
Verified postcode
Edinburgh, United Kingdom· Recruiting

Common questions

What is Farxiga?

Farxiga is the brand name for a medicine called dapagliflozin, which belongs to a group of drugs called SGLT2 inhibitors. It's used to treat diabetes and has also been found to help people with heart failure.

What is an MRI scan?

An MRI (Magnetic Resonance Imaging) is a type of scan that uses strong magnets and radio waves to create detailed pictures of organs and structures inside your body, including your heart.

Will I know if I'm getting the real drug or a dummy pill?

In the second part of the study, it's a 'double-blind' trial, meaning neither you nor your study doctor will know if you're taking the actual drug or a placebo (dummy pill). This helps ensure fair results.

How long will I be in the study?

The length of your participation will depend on which part of the study you're involved in, but the treatment part is for six months, with follow-up appointments.

What is heart failure?

Heart failure means your heart isn't pumping blood as well as it should. It doesn't mean your heart has stopped, but it might struggle to meet your body's needs.

How to find out more

Shruti Joshi, MBBS, MRCP

sjoshi@ed.ac.uk 0131 650 1000 Official trial record

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