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

Condition(s) targeted: Diabetes Mellitus; Heart Failure; Coronary Artery Disease

Intervention: Telmisartan, Bisoprolol (Drug); placebo (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Medical University of Vienna

Official(s) and/or principal investigator(s):
Martin P Huelsmann, MD, Principal Investigator, Affiliation: Medical University of Vienna Dept.of Cardiology
Richard Pacher, MD, Principal Investigator, Affiliation: Medical University of Vienna Dept. of Cardiology
Martin Clodi, MD, Study Director, Affiliation: Medical University of Vienna Dept. of Endocrinology

Overall contact:
Martin P Huelsmann, Dr, Phone: 0043-1-40400-4614, Email: martin.huelsmann@meduniwien.ac.at

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

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

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

Primary outcome: Reduction in cardiac events

Secondary outcome:

Decrease in NT-pro-BNP in the treatment arm

Reduction in NT-proBNP

Minimum age: 19 Years. Maximum age: 95 Years. Gender(s): Both.

Criteria:

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

Martin P Huelsmann, Dr, Phone: 0043-1-40400-4614, Email: martin.huelsmann@meduniwien.ac.at

General Hospital of Vienna Department of Endocrinology, Vienna 1090, Austria; Recruiting
Martin Clodi, MD, Phone: +43-1-40400-4311, Email: martin.clodi@meduniwien.ac.at
Martin Clodi, MD, Sub-Investigator

Starting date: November 2007
Ending date: November 2010
Last updated: November 23, 2007