Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT06616233
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years
* Ability to provide written consent
* clinical diagnosis of HFpEF (LVEF ≥50%; symptoms and signs of heart failure \[HF\] caused by a structural and/or functional abnormality, and at least one: elevated natriuretic peptides; ambulatory; BNP ≥35 pg/mL or NT-proBNP ≥125 pg/mL or hospitalised; BNP ≥100 pg/mL or NT-proBNP ≥300 pg/mL, and objective evidence of cardiogenic pulmonary or systemic congestion) OR stable type 2 diabetes (determined by formal diagnosis in hospital or GP case records with diagnostic oral glucose tolerance test or glycated haemoglobin level ≥6.5%) and with ACC/AHA stage B HF (structural disorder of the heart but no current or previous symptoms of HF) OR confirmed diagnosis of dilated cardiomyopathy
Exclusion Criteria:
* Absolute contraindications to MRI or contrast (e.g. severe claustrophobia, pregnancy, ferromagnetic implants, inability to lie flat, severe renal impairment eGFR\<30ml/min/m2)
* Moderate to severe valvular heart disease
* Confirmed coronary artery disease (\>50% narrowing in any major epicardial coronary artery on invasive or computed tomography coronary angiography, previous myocardial infarction, previous percutaneous intervention or coronary bypass surgery)
* Known arterial stenosis of the upper extremity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06616233
Study Brief:
Protocol Section:
NCT06616233