Disease in the small blood vessels, heart failure and diabetes
| ISRCTN | ISRCTN17603598 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17603598 |
| IRAS number | 348083 |
| Secondary identifying numbers | BHF (Funder) - FS/ICRF/24/26101, CPMS 66745 |
- Submission date
- 20/05/2025
- Registration date
- 26/05/2025
- Last edited
- 01/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Heart failure (HF) outcomes are worse in people with type 1 (T1D) and type 2 diabetes (T2D) than in those without diabetes. However, research in this area is lacking and has primarily focused on T2D. There is limited understanding of the pathophysiology of HF in T1D despite its poor prognosis.
The overall aim of this study is to address this knowledge gap in the prevention and treatment of HF in individuals with T1D. The presence of cardiac microvascular disease (MVD) may play an important role in HF and T1D. This study will explore the role of cardiac MVD in patients with T1D and HF using a comprehensive assessment of cardiac imaging in people with and without T1D and HF. This study will address a significant unmet need, providing novel insights into HF in T1D that may support improved prevention and treatment of HF in T1D in future.
Who can participate?
Patients aged 18 years and over with at least one of the following conditions:
1. Diabetes (type 1 or type 2)
2. Heart Failure
3. High blood pressure
4. People with no prior heart problems
What does the study involve?
Participants will attend a study visit during which they will:
1. Have a clinical examination, including measuring height and weight
2. Complete between one and three questionnaires about their health
3. Provide blood and urine samples
4. Have an ECG (heart tracing), echocardiogram (heart ultrasound) and heart MRI scan
5. Have a photograph of the back of their eye taken
6. Have a test of blood flow in their skin
A subset of patients will return for exactly the same tests at 2 years.
What are the possible benefits and risks of participating?
Heart failure and diabetes are major public health issues worldwide. There may not be any direct benefits to participants immediately from taking part in the study, but the information obtained will be useful to understand the problems patients with heart disease and/or diabetes have. In future, the study findings might be useful in understanding why heart failure develops and in developing new treatments for heart failure. The results of this study will be of interest to those involved in providing healthcare and may influence the way we use existing treatments and the advice we give.
If we do identify something that may impact on a participant's clinical care we will tell them and their GP or other relevant specialist.
The blood sampling has a very small risk of infection because we will make a hole in the skin. There may be some bruising or redness of the area around the needle entry but this does not usually cause any issues. In rare instances some people faint or feel wobbly.
The echocardiography test can sometimes be a little uncomfortable as we occasionally need to press on the chest with the probe to get good pictures, but generally patients manage this without any problems. If you find that the exercise is too much (during the echo scan), you will be able to stop immediately.
During the ECG or testing of the function of the small blood vessels in your skin, the participant's skin may react to the sticky electrode patches. Any skin irritation usually disappears when the patches are removed.
An MRI scan is a safe and painless test that can provide detailed pictures of organs and other structures inside the body. Rarely, people may develop reactions to the contrast agent (dye) and adenosine. They may feel a little short of breath or have a tight chest during the infusion of adenosine, but this feeling passes very quickly once the infusion is stopped.
Where is the study run from?
The study has been organised by the Cardiovascular Research team at the University of Dundee with activities taking place in Ninewells Hospital (UK)
When is the study starting and how long is it expected to run for?
June 2024 to January 2031
Who is funding the study?
British Heart Foundation (UK)
Who is the main contact?
Dr Ify Mordi, i.mordi@dundee.ac.uk
Contact information
Public, Scientific, Principal Investigator
Division of Cardiovascular Research
School of Medicine
Dundee
DD1 9SY
United Kingdom
| Phone | +44 (0)1382385591 |
|---|---|
| i.mordi@dundee.ac.uk |
Study information
| Study design | Single-centre observational cross-sectional/cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross-sectional/cohort study |
| Study setting(s) | University/medical school/dental school |
| Study type | Diagnostic |
| Participant information sheet | 47370_PIS_V2.0_09Jan25.pdf |
| Scientific title | A cohort study to evaluate the relationship between cardiac microvascular dysfunction, diabetes and cardiac structural and functional abnormalities |
| Study acronym | MIDAS-HEART |
| Study objectives | The study hypothesis is that cardiac microvascular disease plays an important role in the development and progression of heart failure in individuals with type 1 diabetes. |
| Ethics approval(s) |
Approved 24/02/2025, East of Scotland REC 2 (TAyside medical Science Centre, Residency Block, Level 3, George Pirie Way, Ninewells Hospital and Medical School, Dundee, DD1 9SY, United Kingdom; +44 (0)1382 383871; tay.eosres@nhs.scot), ref: 24/ES/0092 |
| Health condition(s) or problem(s) studied | People with heart failure, diabetes and/or hypertension |
| Intervention | The researchers will study people with and without diabetes, and people with and without heart failure. Following informed consent, all participants will have a baseline assessment (this may be done as a single visit or split into two visits depending on logistics and participant preference). This assessment will include: 1. A clinical evaluation (medical history, symptoms, prescriptions) 2. Blood and urine tests 3. Heart scans (echocardiography and MRI scan) 4. Between one and three questionnaires to assess their quality of life (number based on whether they have heart failure and/or diabetes) 5. A photograph of the back of the eyes 6. An assessment of the small blood vessels of the skin If this assessment is split into two visits, these visits will be done within 14 days of each other. Following this initial assessment, participants will be followed up using electronic health records to assess for clinical events (death and hospital admissions, medication prescribing). Participants either without heart failure at baseline or with type 1 diabetes and heart failure at baseline will be recalled at 2 years for a follow-up study visit, where all of the above assessments will be repeated. |
| Intervention type | Other |
| Primary outcome measure | Stress myocardial blood flow measured in ml/g/min during adenosine stress cardiovascular magnetic resonance (CMR) at baseline and 2 years |
| Secondary outcome measures | 1. Myocardial perfusion reserve (units) during adenosine stress CMR at baseline and 2 years. 2. Incidence of new heart failure diagnosis (percentage) at 2 years |
| Overall study start date | 01/06/2024 |
| Completion date | 31/01/2031 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 360 |
| Key inclusion criteria | All individuals must be aged ≥18 years. Seven groups of participants will be included: Group 1 participants: Documented diagnosis of Type 1 diabetes (T1D) and heart failure (HF). Diagnosis of HF, regardless of left ventricular ejection fraction (LVEF), will be defined as one or more of the following: 1. Previous HF hospitalisation where HF was documented as the primary cause of hospitalisation and there was a requirement for loop diuretics. 2. Impaired left ventricular (LV) function (i.e. LVEF <50% by any imaging modality) 3. Symptoms and signs of heart failure with elevated N-terminal proBNP and any of the following: 3.1. Preserved LV systolic function (LVEF ≥50%) with left atrial enlargement (2-dimensional echocardiographic measurement of left atrial width ≥3.8cm or left atrial length ≥5.0 cm or left atrial area ≥20 cm2 or left atrial volume index >29 ml/m2) 3.2. Preserved LV systolic function (LVEF ≥50%) with left ventricular hypertrophy (2-dimensional echocardiographic measurement of end-diastolic interventricular septal diameter ≥1.2cm or end-diastolic left ventricular posterior wall diameter ≥1.2 cm). 3.3. Preserved LV systolic function (LVEF ≥50%) with echocardiographic diastolic dysfunction (septal e’ <7 cm/sec or lateral e’ <10 cm/sec or average E/e’ ≥15). Group 2 participants: Documented diagnosis of Type 2 diabetes (T2D) and heart failure (HF) as defined for group 1. Group 3 participants: Diagnosis of HF as defined for group 1 without diabetes (type 1 or type 2). Group 4 participants: Diagnosis of Type 1 diabetes without heart failure. Group 5 participants: Diagnosis of Type 2 diabetes without heart failure. Group 6 participants: Documented diagnosis of hypertension on at least 2 anti-hypertensive drugs, without a diagnosis of heart failure or diabetes. Group 7 participants: Individuals with no prior diagnosis of cardiovascular disease, diabetes or hypertension. |
| Key exclusion criteria | 1. End-stage heart failure requiring left ventricular assist devices, intra-aortic balloon pump, or any type of mechanical support at the time of recruitment 2. Documented primary severe valvular heart disease, amyloidosis or hypertrophic cardiomyopathy as the principal cause of heart failure as judged by the investigator 3. Presence of malignancy with expected life expectancy <1 year at screening 4. Contraindications to MRI, including claustrophobia, metal implants in the body deemed not MRI safe 5. Severe asthma requiring admission to intensive care in the last 2 years 6. Unable/unwilling to give consent |
| Date of first enrolment | 14/06/2025 |
| Date of final enrolment | 31/01/2030 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Dundee
DD1 9SY
United Kingdom
Sponsor information
University/education
School of Medicine
TASC Governance
Dundee
DD1 9SY
Scotland
United Kingdom
| Phone | +44 (0)1382660111 |
|---|---|
| tascgovernance@dundee.ac.uk | |
| Website | https://www.dundee.ac.uk |
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2031 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer-reviewed journals and presentation at national and international conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Ify Mordi (i.mordi@dundee.ac.uk). Anonymised (non-identifiable) data will be shared if participants have consented to do so. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 09/01/2025 | 22/05/2025 | No | Yes |
Additional files
Editorial Notes
01/07/2025: Internal review.
20/05/2025: Study's existence confirmed by the East of Scotland Research Ethics Service.
