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Disease in the small blood vessels, heart failure and diabetes

A cohort study to evaluate the relationship between cardiac microvascular dysfunction, diabetes and cardiac structural and functional abnormalities

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN17603598
Enrollment
360
Registered
2025-05-26
Start date
2025-06-14
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

People with heart failure, diabetes and/or hypertension Other

Interventions

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 a

Sponsors

University of Dundee
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Stress myocardial blood flow measured in ml/g/min during adenosine stress cardiovascular magnetic resonance (CMR) at baseline and 2 years

Secondary

MeasureTime frame
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

Countries

Scotland, United Kingdom

Contacts

Public ContactIfy Mordi
i.mordi@dundee.ac.uk+44 (0)1382385591

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026