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

This study has been completed.
Roche Pharma AG
Information provided by (Responsible Party):
Martin Huelsmann, Medical University of Vienna
ClinicalTrials.gov Identifier:
First received: November 23, 2007
Last updated: May 2, 2012
Last verified: May 2012
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 2
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Reduction in cardiac events [ Time Frame: 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease in NT-pro-BNP in the treatment arm [ Time Frame: 1 ] [ Designated as safety issue: No ]
  • Reduction in NT-proBNP [ Time Frame: 1 ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: November 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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

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Ages Eligible for Study:   19 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00562952

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
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

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 
Study First Received: November 23, 2007
Last Updated: May 2, 2012
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Vienna:
Natriuretic peptide
Heart failure
Heart disease

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Failure
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 05, 2016