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:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT05705869
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥40 years of age
* Informed consent
* An established diagnosis of diabetes (type 1 or type 2)
* At least one additional risk factor for heart failure:
1. Coronary artery disease (either a previous documented type 1 myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention or documented stenosis of an epicardial coronary artery \[50% left main or \>70% left anterior descending, circumflex or right coronary artery\])
2. Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation)
3. Previous ischemic or embolic stroke
4. Peripheral arterial disease (previous surgical or percutaneous revascularisation or a documented stenosis greater than 50% of a major peripheral arterial vessel).
5. Chronic kidney disease (defined as an estimated glomerular filtration rate \<60mL/min/1.73m2 or eGFR 60-90mL/min/1.73m2 and UACR \>300mg/g).
6. Regular loop diuretic use (any dose at any dosing interval) for \>30 days.
7. COPD (evidenced by one of the following; PFTs showing airway obstruction, diagnosis by respiratory physician, CT scan reporting presence of emphysema or treatment with national guideline-advocated COPD therapy).
Exclusion criteria:
* Inability to give informed consent e.g., due to significant cognitive impairment.
* Previous documented diagnosis of heart failure.
* Currently receiving scheduled renal replacement therapy.
* Anyone who, in the investigators' opinion, is not suitable to participate in the trial for other reasons e.g., a diagnosis which may compromise survival over the study period
Exclusion Criteria:
* Inability to give informed consent e.g., due to significant cognitive impairment.
* Previous documented diagnosis of heart failure.
* Currently receiving scheduled renal replacement therapy.
* Anyone who, in the investigators' opinion, is not suitable to participate in the trial for other reasons e.g., a diagnosis which may compromise survival over the study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05705869
Study Brief:
Protocol Section:
NCT05705869