T-proBNP Selected PreventiOn of cardiac eveNts in a populaTion of dIabetic patients without A history of Cardiac disease a prospective randomized trial<br>

Phase 4

Completed

Conditions: diabetes cardiac disease
diabetes mellitus
10012653

Registration Number: NL-OMON47526

Lead Sponsor: Medical university of Vienna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

Type-2 diabetes mellitus for at least six months
>18 years of age men or female
written informed consent to participate in the study and ability to comply with
all requirements

Exclusion Criteria

maximum dose of RAS-antagonists or beta-blocker
symptomatic hypotension and/or systolic blood pressure < 100 mgHG at visit 1
symptomatic bradycardia and/or heart rate < 60 bpm at visit 1
history of hypersensivity to any of the drugs investigated as well as known or
suspected contraindications to the study drug of previous history of
intolerance to high dose of RAAS antagonists or beta-blocker in the absence of
any other bloddpressure lowering drugs
Creatinin > 2.5 mg/dl

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Superiority of high dose treatment with RAS-antagonists and beta-blockers<br /><br>compared to conventional therapy regarding the reduction of unplanned<br /><br>hospitalization or death due to a cardiac event in T2DM patients with a<br /><br>NT-proBNP > 125pg/ml.<br /><br>Co-primary objective<br /><br>Superiority of high dose treatment with RAS-antagonists and beta-blockers<br /><br>compared to conventional therapy regarding the reduction of unplanned<br /><br>hospitalization or death due to a cardiac event in T2DM patients in the whole<br /><br>study population</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Dependency of treatment efficacy (reduction of unplanned hospitalization or<br /><br>death due to a cardiac event in T2DM patients) on the NT-proBNP concentration<br /><br>(interaction effect between NT-proBNP concentrations and treatment).</p><br>