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NCT05705869
Targeted Assessment in High-Risk paTients With dIAbetes to ideNtify Undiagnosed Heart Failure
Conditions: Heart Failure, Diabetes Mellitus, Type 1 Diabetes, Type 2 Diabetes, Cardiovascular Diseases
Sex: All
Ages: 40 Years – N/A
Phase: NA
Enrollment: 1000
Sponsor: NHS Greater Glasgow and Clyde
Location: United Kingdom
Summary
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 Criteria
Inclusion Criteria:Male or female ≥40 years of ageInformed consentAn established diagnosis of diabetes (type 1 or type 2)At least one additional risk factor for heart failure: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])Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation)Previous ischemic or embolic strokePeripheral arterial disease (previous surgical or percutaneous revascularisation or a documented stenosis greater than 50% of a major peripheral arterial vessel).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).Regular loop diuretic use (any dose at any dosing interval) for >30 days.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 periodExclusion 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
Source: ClinicalTrials.gov (NCT05705869). StuddyBuddy aggregates publicly available trial information.