IMID-HEART

Description – IMID-HEART Study

Immune-mediated inflammatory diseases (IMIDs), such as scleroderma, rheumatoid arthritis, lupus (SLE), myositis, and dermatomyositis, affect many thousands of people in the UK. People living with these conditions have a higher chance of developing heart problems. These can include heart failure, inflammation of the heart muscle, abnormal heart rhythms, and problems with the small blood vessels that supply the heart. Heart problems can affect daily activities, long-term health, and life expectancy.

Heart problems in people with IMIDs are often missed or found later than they should be. This is because symptoms such as tiredness, shortness of breath, or chest discomfort can be similar to symptoms of the inflammatory condition itself. At present, there is no clear or consistent system across the UK to decide which IMID patients should have more detailed heart tests. As a result, some people may have tests they do not need, while others may have early heart problems that are not picked up in time.

Research studies and reports from patient organisations, including Scleroderma & Raynaud’s UK, Lupus UK, Myositis UK, and the National Rheumatoid Arthritis Society, highlight that people living with IMIDs value early detection of heart problems and prefer safe, non-invasive tests whenever possible. Many also report concerns about the discomfort, risks, travel, and time involved in more invasive investigations.

The IMID-HEART study aims to find better ways to check heart health in people with IMIDs using safe, non-invasive, and patient-friendly tests. As part of the study, participants will have a heart MRI scan, which provides detailed pictures of the heart and helps identify early signs of heart involvement without the need for surgery or invasive procedures.

Some participants may also be offered a medication called dapagliflozin, which is already used in routine care for certain heart conditions. The study will look at how this medication affects the heart over time using repeat heart MRI scans and blood tests.

By bringing together heart MRI scans, blood tests, and routine clinical information, we hope to:

Find heart problems earlier
Reduce the need for invasive tests
Improve long-term heart health and quality of life for people living with IMIDs

Our aim is to make heart care for people with IMIDs simpler, safer, and more comfortable, so that heart problems can be identified sooner and managed more effectively.

Dapagliflozin will be administered to all three groups. Groups 1 and 2 will undergo cardiac MRI assessments pre- and post-treatment, whereas Group 3 will undergo MRI evaluation only following treatment.”

Dapagliflozin

helps lower blood sugar and support heart health in a simple way.

About dapagliflozin – NHS

About Dapagliflozin (Forxiga) – What it is and how it works

Dapagliflozin is a medication that helps lower blood sugar by helping the kidneys remove extra sugar from the body through urine. It works independently of insulin, which means it can help even if your body isn’t making enough insulin.

It can also support heart health by:

Reducing fluid in the body, which eases the workload on the heart

Improving the way the heart uses energy

Potentially reducing inflammation and helping protect the heart muscle

Who should NOT take dapagliflozin

Dapagliflozin is not suitable for people with:

Type 1 diabetes
Severe kidney problems
A history of serious allergic reactions to the medication

Possible side effects

Common side effects may include:

Yeast infections (in women or men) causing itching, redness, or discharge

Urinary tract infections, with symptoms like burning when urinating or needing to go more often

Increased urination, sometimes at night

Dehydration, which may cause dizziness or weakness

Mild back pain or skin rashes

Less common but serious side effects need immediate medical attention:

Diabetic ketoacidosis (DKA): nausea, vomiting, stomach pain, confusion, or fruity-smelling breath

Severe infections of the genital area (Fournier’s gangrene): pain, swelling, redness, fever

Kidney problems: swelling in legs, fatigue, reduced urine output

Severe allergic reactions: swelling of the face, lips, tongue, throat, or difficulty breathing

Important note: Low blood sugar is rare with dapagliflozin alone but can happen if used with insulin or other diabetes medications.

How to take it

Usually once daily, with or without food

Take it around the same time each day (many prefer morning)

Swallow the tablet whole—do not crush, cut, or chew it

How it’s given in the study

Dapagliflozin will be prescribed by the NHS cardiology team at Leeds General Infirmary

The hospital pharmacy will provide the medication and instructions

Participants will get a treatment diary to record daily doses and help monitor compliance

Monitoring and safety

Before starting dapagliflozin, participants will have:

Blood tests to check kidney and liver function, electrolytes, and heart markers (BNP, troponin)

Blood pressure measurements

Screening for previous urinary or genital infections

During the study, participants will be carefully monitored for any side effects, and the clinical team will provide guidance on what to do if any problems occur.

Visits and investigations.

All study assessments are carried out at the Advanced Imaging Centre (AIC) at Leeds General Infirmary. Participants will continue taking their usual medications throughout the study. Participants will have a total of 3 visits.

Visit 1 Week 1

Blood tests
Review of medical history
Check inclusion/exclusion criteria
Height & weight
MRI 1
Prescription provided

Visit 2 Week 6

Vital signs check
Physical examination
Blood pressure & weight
Fasting blood sample
12-lead ECG
Medication review & diary
Urine sample collection
HbA1c

Visit 3 Week 12

MRI 2 (follow-up scan)
Blood & urine

BNP, troponin, CK
FBC
Urea & electrolytes
Liver function test
HbA1c

Follow-up review

MRI (Heart Scan)

As part of the study, participants will have a specialized heart scan called a multiparametric MRI. This scan helps us look at both the structure and function of your heart, as well as how your heart uses energy.

What the scan includes

The MRI Scan is 2 parts:

Part 1: Magnetic Resonance Spectroscopy (MRS)
- This part of the scan looks at how your heart cells use energy. It measures natural chemicals in the heart that are involved in energy production. This helps researchers understand how well the heart muscle is working at a cellular level. This part of the scan is done at rest.
Part 2: Cardiovascular Magnetic Resonance (CMR)
- Provides detailed images of your heart to check:
  - Size and pumping function of the heart (LV size & function)
  - How the heart muscle moves and strains
  - Blood flow and perfusion
  - Areas of scarring or fibrosis

For the second part, the heart may be stressed using a medication called adenosine, which temporarily increases blood flow in the heart, similar to gentle exercise. During this time, your heart rate, blood pressure, heart rhythm (ECG), and how you are feeling will be closely monitored.

While the stress test is taking place, a contrast agent called gadolinium (Gadovist®) will be injected to help show blood flow in the heart more clearly. The amount used is small, carefully controlled, and considered safe. You may notice warmth or flushing, mild chest discomfort, or shortness of breath, but these sensations are short-lived and usually pass quickly, as adenosine works for only a very short time.

Safety and comfort

The scan is non-invasive and generally very safe.
The team will guide you throughout the process and ensure you are comfortable at all times.
Only standard, clinically approved procedures and doses are used.

Full study participant information sheet

View Full Sheet

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