Asian Diabetes Outcomes Prevention Trial
National Heart Centre Singapore
2,400 participants
Jul 1, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria12
- 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
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Interventions
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.
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04286399