Nt-proBNP Guided Prevention of Cardiovascular Events in a Population of Diabetic Patients Without a History of Cardiac Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

November 23, 2007

Last Updated Date

November 23, 2007

Start Date ^ICMJE

November 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Reduction in cardiac events [ Time Frame: 2 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Decrease in NT-pro-BNP in the treatment arm [ Time Frame: 1 ]
Reduction in NT-proBNP [ Time Frame: 1 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Nt-proBNP Guided Prevention of Cardiovascular Events in a Population of Diabetic Patients Without a History of Cardiac Disease

Official Title ^ICMJE

Nt-proBNP Guided Prevention of Cardiovascular Events in a Population of Diabetic Patients Without a History of Cardiac Disease

Brief Summary

Increased levels of NT-proBNP are known to increase the risk of cardiac events in diabetic patients. The other way around, patients with normal values have an excellent prognosis on short-term. We intend in our study to proof the hypothesis, whether it is possible to decrease NT-proBNP levels by intensified cardiac prevention care We aim those patients, who already have elevated levels, although no history of a cardiac disease. This decrease in NT-proBNP should be translated consequently in a decrease in cardiac events

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Diabetes Mellitus
Heart Failure
Coronary Artery Disease

Intervention ^ICMJE

Drug: Telmisartan, Bisoprolol
Drug: placebo

Study Arms / Comparison Groups

Active Comparator: Patient will receive cardiac therapy to decrease NT-proBNP levels. This will be primarily RAAS-Antagonists and Betablocker. Blood pressure will be lowered to target values. A decrease of NT-proBNP is also known form life-style changes. Thus the patient will be educated to be trained
Placebo Comparator: Patients will be followed 2 years. Care will be given by the responsible unit ( Dept.of Endocrinology) as clinical appropriate. Event rates will be obtained. After one year NT-proBNP will be measured.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

November 2010

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age > 18 years
Known Diabetes mellitus > 6 months
Increased Nt-proBNP above 125pg/ml
Given informed consent

Exclusion Criteria:

Disease other than diabetes, with a life expectancy below 1 year
patients who suffer from chronic infection or malignant disease
Women in childbearing age without contraceptive
History of cardiac disease
systemic cortisone treatment
patients who are on chronic or acute hemodialysis, ultra filtration or peritoneal dialysis

Gender

Both

Ages

19 Years to 95 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Martin P Huelsmann, Dr

0043-1-40400-4614

martin.huelsmann@meduniwien.ac.at

Location Countries ^ICMJE

Austria

Administrative Information

NCT ID ^ICMJE

NCT00562952

Responsible Party

Study ID Numbers ^ICMJE

01/07, EK-Nr 391/2007

Study Sponsor ^ICMJE

Medical University of Vienna

Collaborators ^ICMJE

Hoffmann-La Roche

Investigators ^ICMJE

Principal Investigator:	Martin P Huelsmann, MD	Medical University of Vienna Dept.of Cardiology
Principal Investigator:	Richard Pacher, MD	Medical University of Vienna Dept. of Cardiology
Study Director:	Martin Clodi, MD	Medical University of Vienna Dept. of Endocrinology

Information Provided By

Medical University of Vienna

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP