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Nt-proBNP Guided Primary Prevention of CV Events in Diabetic Patients (PONTIAC)

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ClinicalTrials.gov Identifier: NCT00562952
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : May 3, 2012
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Martin Huelsmann, Medical University of Vienna

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Heart Failure Coronary Artery Disease Drug: Telmisartan, Bisoprolol Drug: placebo Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Reduction in cardiac events [ Time Frame: 2 ]

Secondary Outcome Measures :
  1. Decrease in NT-pro-BNP in the treatment arm [ Time Frame: 1 ]
  2. Reduction in NT-proBNP [ Time Frame: 1 ]


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Ages Eligible for Study:   19 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562952


Locations
Austria
General Hospital of Vienna Department of Endocrinology
Vienna, Austria, 1090
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Roche Pharma AG
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martin Huelsmann, Doz., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00562952     History of Changes
Other Study ID Numbers: 01/07
EK-Nr 391/2007 ( Other Identifier: Medical University of Vienna )
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: May 3, 2012
Last Verified: May 2012

Keywords provided by Martin Huelsmann, Medical University of Vienna:
Natriuretic peptide
Prognosis
Diabetes
Heart failure
Heart disease

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Telmisartan
Bisoprolol
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
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