Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT05705869
Brief 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.
Detailed Description:
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.
Participants will be recruited from the diabetes service in two NHS health boards in Scotland; NHS Greater Glasgow and Clyde and NHS Lanarkshire. At the point of recruitment and consent, patients will be randomised to one of two arms:
1. "Routine care arm" - patients in this arm will undergo routine diabetes care. They will be managed and followed up as per routine clinical care. They will be remotely monitored for HF events electronically. Quality of life questionnaires (Kansas City Cardiomyopathy Questionnaire-12 and EQ-5D) will be completed electronically through CASTOR program in this arm (with the option of paper versions for participants who can not use CASTOR).
OR
2. "Investigational arm" - patients in this arm will have a blood sample taken to measure N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) using a Roche assay. In addition to this, blood samples for haemoglobin, creatinine, HbA1c, cholesterol profile, liver function tests and eGFR will be collected. Quality of life questionnaires (Kansas City Cardiomyopathy Questionnaire-12 and EQ-5D) will be completed electronically through CASTOR program in this arm (with the option of paper versions for participants who can not use CASTOR).
All patients in this arm will also have an ECG and basic body measurements and observations measured. Further venous blood samples will be collected and stored within Glasgow University storage facilities for future measurement of relevant biomarkers and for use in future ethically approved research. Urine samples will also be collected for measurement of urine albumin:creatinine ratio and for future measurement of relevant biomarkers and use in future ethically approved research.
Patients with an elevated Roche NT-proBNP (≥125 pg/mL) will undergo a full cart-based transthoracic echocardiogram along with a clinical examination for signs of HF and a HF symptom assessment. A British Society of Echocardiography minimum dataset will be obtained, and report created.
Patients will then also undergo a handheld echocardiogram with a CE-marked handheld point of care (POC) EchoNous Kosmos echocardiogram device. The handheld echocardiogram images will be acquired by a British Society of Echocardiography accredited operator. The US2.ai algorithm (which is also CE marked) will generate an AI-automated echocardiogram report.
Patients who are classified as having heart failure (HFrEF, HFmrEF, or HFpEF) will be managed according to the latest version of European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure. The results of the cart-based echocardiogram will be used during the determination of the presence or absence of HF.
Study:
NCT05705869
Study Brief:
Protocol Section:
NCT05705869