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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
|---|---|
|
Active Comparator: 1
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
|
|
Placebo Comparator: 2
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
| ClinicalTrials.gov Identifier: | NCT00562952 History of Changes |
| Other Study ID Numbers: | 01/07, EK-Nr 391/2007 |
| Study First Received: | November 23, 2007 |
| Last Updated: | November 23, 2007 |
| Health Authority: | Austria: Ministry of Health |
|
Natriuretic peptide Prognosis Diabetes Heart failure Heart disease |
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Diabetes Mellitus Heart Diseases Heart Failure Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Bisoprolol Telmisartan |
Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Angiotensin II Type 1 Receptor Blockers |
