Preventing heart disease in high-risk diabetes patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to identify adults with type 2 diabetes who are at high risk for cardiovascular disease based on elevated NT-proBNP levels. It will test whether intensifying therapy with specific medications, including renin-angiotensin system inhibitors, beta-blockers, and SGLT2 inhibitors, can reduce cardiovascular events compared to standard care. The study will be conducted across five Asian regions, involving approximately 2,400 patients followed for two years. Participants must be at least 40 years old and have no known cardiovascular disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Type 2 diabetes for at least six months
* ≥ 40 years of age, men or women
* No known cardiovascular disease ( defined as known coronary stenosis \> 70%, reduced left ventricular ejection fraction \< 40%, or a history of myocardial infarction/ coronary revascularization/ heart failure hospitalization/ stroke/ prior non-traumatic lower limb amputation or angioplasty)
* NT-proBNP \> 125 pg/mL
* Written informed consent

Exclusion Criteria:

* History of hypersensitivity to any of the drugs investigated as well as known or suspected contraindications to the study drugs or previous history of intolerance
* Patients already on a maximum dose of RAASi or beta-blocker
* History of DM ketoacidosis/Type 1 DM
* eGFR \< 45ml/min/1.73m2
* Symptomatic hypotension and/or Visit 1 systolic blood pressure (SBP) \< 100mmHg.
* Symptomatic bradycardia, high-grade AV blocks (Grade 2 and 3) and/or Visit 1 heart rate (HR) \< 60bpm.
* Any disease other than diabetes lowering the patient's life expectancy to less than two years.
* Chronic infections (E.g. chronic cystitis, recurrent urinary tract infections) or malignancies or uncontrolled thyroid disorder or liver disease
* Systemic treatment with corticosteroids.
* Pregnant or nursing women
* Any other clinical condition that might affect patients' safety during trial, at the investigator's discretion.
* Participation in an investigational drug trial

Where it's running

• Singapore General Hospital (SGH)
  Singapore, Singapore Recruiting

Study contacts

• Study coordinator: Serene Ng Miss
• Email: serene.ng.b.l@singhealth.com.sg
• Phone: 67042232

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.