Renin-angiotensin-aldosterone system inhibitors: Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.
Beta blocker: Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.
SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor Product: Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.
Study summary
The aim of this study is to identify patients with DM at high risk of CVD using elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (\>125pg/mL), and (2) intensify therapy using renin-angiotensin system (RAS) antagonists, beta-blockers and sodium glucose co-transporter-2 inhibitors (SGLT2i) for primary prevention of cardiovascular events in this high-risk DM population.
Eligibility
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Combined endpoint based on the first occurrence of cardiovascular death or major adverse cardiovascular event — 48 months Stroke/myocardial infarction/heart failures events
Trial sites (1)
Facility
City
Region
Status
Singapore General Hospital (SGH)
Singapore
Singapore
Recruiting
More National Heart Centre Singapore trials in Singapore
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.