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

NCT00562952 | Completed Phase 2

• 2 other identifiers: 01/07EK-Nr 391/2007
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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

Conditions

Diabetes Mellitus; Heart Failure; Coronary Artery Disease

Keywords

Natriuretic peptide; Prognosis; Diabetes; Heart failure; Heart disease

Outcome Measures

Primary Outcomes (1)

• Reduction in cardiac events

  2

Secondary Outcomes (2)

• Decrease in NT-pro-BNP in the treatment arm

  1

• Reduction in NT-proBNP

  1

Study Arms (2)

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

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

Interventions

Telmisartan, Bisoprolol DRUG

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

1

placebo DRUG

no intervention

2

Eligibility Criteria

• Age: 19 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Known Diabetes mellitus \> 6 months
• Increased Nt-proBNP above 125pg/ml
• Given informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Roche Pharma AG: collaborator

Study Sites (2)

General Hospital of Vienna Department of Endocrinology

Vienna, 1090, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• Huelsmann M, Neuhold S, Resl M, Strunk G, Brath H, Francesconi C, Adlbrecht C, Prager R, Luger A, Pacher R, Clodi M. PONTIAC (NT-proBNP selected prevention of cardiac events in a population of diabetic patients without a history of cardiac disease): a prospective randomized controlled trial. J Am Coll Cardiol. 2013 Oct 8;62(15):1365-72. doi: 10.1016/j.jacc.2013.05.069. Epub 2013 Jun 27.

  PMID: 23810874 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Heart Failure; Coronary Artery Disease; Heart Diseases

Interventions

Telmisartan; Bisoprolol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines

Study Officials

• Martin P Huelsmann, MD

  Medical University of Vienna Dept.of Cardiology

  PRINCIPAL INVESTIGATOR

• Richard Pacher, MD

  Medical University of Vienna Dept. of Cardiology

  PRINCIPAL INVESTIGATOR

• Martin Clodi, MD

  Medical University of Vienna Dept. of Endocrinology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doz.

Study Record Dates

• First Submitted: November 23, 2007
• First Posted: November 26, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 3, 2012

Record last verified: 2012-05

Locations

AU (2)