T-proBNP selected prevention of cardiac events in a population of diabetic patients without a history of cardiac disease (Pontiac II); a prospective randomized trial - PONTIAC II

Medical University of Vienna0 sites2,400 target enrollmentNovember 29, 2017

Overview

No summary available.

Registry

who.int

Start Date

November 29, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\) Type\-2 diabetes mellitus \- diagnosed for at least six months prior to inclusion
•2\) \= 18 years of age, male or female
•3\) Written informed consent to participate in the study and ability to comply with the study requirements.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 75
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 75

•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.