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

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Martin Huelsmann, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00562952
First received: November 23, 2007
Last updated: May 2, 2012
Last verified: May 2012
  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 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 95 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Medical University of Vienna

Additional 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
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

ClinicalTrials.gov processed this record on September 30, 2014