Screening for undiagnosed heart failure in high-risk diabetes patients
Targeted Assessment in High-Risk paTients With dIAbetes to ideNtify Undiagnosed Heart Failure (TARTAN-HF)
This study is testing a new way to find undiagnosed heart failure in people with diabetes who are at high risk, by using blood tests and heart checks to see if it helps them get better care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | NHS Greater Glasgow and Clyde Academic / other |
| Drugs / interventions | cart |
| Locations | 2 sites (Glasgow, Scotland and 1 other locations) |
| Trial ID | NCT05705869 on ClinicalTrials.gov |
What this trial studies
This prospective, multicentre, unblinded, randomised, controlled trial aims to evaluate a targeted screening strategy for detecting undiagnosed heart failure in high-risk patients with diabetes. Participants will be recruited from diabetes services in two NHS health boards in Scotland and will be randomly assigned to either routine care or an investigational arm that includes blood tests and ECGs. The investigational arm will measure NT-proBNP levels and other relevant biomarkers, while both arms will complete quality of life questionnaires. The study seeks to improve early detection of heart failure in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older with an established diagnosis of diabetes and at least one additional risk factor for heart failure.
Not a fit: Patients without diabetes or those under 40 years of age may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and management of heart failure in patients with diabetes, potentially improving their overall health outcomes.
How similar studies have performed: Other studies have shown success in using targeted screening approaches for heart failure detection in similar high-risk populations, indicating potential for this study's success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Glasgow, Scotland and 1 other locations
- Glasgow Royal Infirmary — Glasgow, Scotland, United Kingdom (Recruiting)
- Queen Elizabeth University Hospital — Glasgow, Scotland, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Mark C Petrie, MbChB — University of Glasgow
- Study coordinator: Kieran F Docherty, MbChB
- Email: kieran.docherty@glasgow.ac.uk
- Phone: 0141 330 2677
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.