T-proBNP Selected PreventiOn of cardiac eveNts in a populaTion of dIabetic patients without A history of Cardiac disease;a prospective randomized trial - PONTIAC II

Medizinische Universität Wien0 sites2,400 target enrollmentJuly 19, 2017

Overview

No summary available.

Registry

who.int

Start Date

July 19, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\)Type\-2 diabetes mellitus for at least six months,
•2\)\= 18 years of age, men or female,
•3\)Written informed consent to participate in the study and ability to comply with all requirements.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 300
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 300

•1\)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 to high dose of RAAS\-antagonists or beta\-blocker in the absence of any other blood pressure lowering drugs.
•2\)Patients already receiving a maximum dose of RAAS\-antagonists or beta\-blocker.
•3\)Creatinine \> 2\.5mg/dl.
•4\)Symptomatic hypotension and/or systolic blood pressure (SBP) \< 100mmHg at visit 1\.
•5\)Symptomatic bradycardia and/or heart rate (HR) \< 60bpm at visit 1\.
•6\)Signs of cardiac disease in the electrocardiogram such as atrial fibrillation; ST\-T abnormalities or a bundle branch block/ higher degree AV block.
•7\)Abnormal echocardiography, defined as low ejection fraction \< 50%; wall motion abnormalities suggesting coronary artery disease (CAD), significant valve dysfunction \> grades I.
•8\)Coronary artery disease, defined by a history of myocardial infarction, known coronary stenosis \> 70% detected either by angiography or by CT\-scan, significant defects in myocardial scintigraphy or positive stress\-test echocardiography.
•9\)A disease other than diabetes lowering the patient’s life expectancy to less than two years.
•10\)Chronic infections or malignancies.