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Targeted Assessment in High-Risk paTients With dIAbetes to ideNtify Undiagnosed Heart Failure

Active Not RecruitingNA

Sponsor: NHS Greater Glasgow and Clyde

Conditions: Heart Failure, Diabetes Mellitus, Type 1 Diabetes, Type 2 Diabetes, Cardiovascular Diseases

Interventions: NT-proBNP

Countries: United Kingdom

This is a prospective, multicentre, unblinded, randomised, controlled trial. The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure in high-risk patients with diabetes.

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
* Echocardiogram or NT-proBNP interpreted as excluding heart failure within 12 months.
* 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

Locations (2)

Glasgow, Scotland, United Kingdom
Glasgow, Scotland, United Kingdom