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| Sponsor: | Medical University of Vienna |
|---|---|
| Collaborator: |
Hoffmann-La Roche |
| Information provided by: | Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00562952 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Heart Failure Coronary Artery Disease |
Drug: Telmisartan, Bisoprolol Drug: placebo |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Nt-proBNP Guided Prevention of Cardiovascular Events in a Population of Diabetic Patients Without a History of Cardiac Disease |
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2010 |
| Arms | Assigned Interventions |
|---|---|
|
1: 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
|
Drug: Telmisartan, Bisoprolol
Dosage will be given dependent on the NT-pro-BNP levels. Up-titration will be performed until values are decreased to 50% or below normal cut-point
|
|
2: 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.
|
Drug: placebo
no intervention
|
Eligibility| Ages Eligible for Study: | 19 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Martin P Huelsmann, Dr | 0043-1-40400-4614 | martin.huelsmann@meduniwien.ac.at |
| Austria | |
| General Hospital of Vienna Department of Endocrinology | Recruiting |
| Vienna, Austria, 1090 | |
| Contact: Martin Clodi, MD +43-1-40400-4311 martin.clodi@meduniwien.ac.at | |
| Sub-Investigator: Martin Clodi, MD | |
| 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 |
More Information
| Study ID Numbers: | 01/07, EK-Nr 391/2007 |
| Study First Received: | November 23, 2007 |
| Last Updated: | November 23, 2007 |
| ClinicalTrials.gov Identifier: | NCT00562952 History of Changes |
| Health Authority: | Austria: Ministry of Health |
|
Natriuretic peptide Prognosis Diabetes Heart failure Heart disease |
|
Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Physiological Effects of Drugs Arteriosclerosis Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Adrenergic beta-Antagonists Cardiovascular Diseases Telmisartan Arterial Occlusive Diseases Sympatholytics Heart Failure Metabolic Diseases |
Heart Diseases Vascular Diseases Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Coronary Disease Bisoprolol Autonomic Agents Adrenergic Antagonists Peripheral Nervous System Agents |
