NT-proBNP Selected PreventiOn of Cardiac eveNts in a populaTion of dIabetic Patients Without A History of Cardiac Disease: a Prospective Randomized Trial

Who is this study for? Adult patients with type 2 diabetes
What treatments are being studied? RAS-antagonist and beta-blocker up-to maximal dosages
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Purpose and rationale The purpose of this study is to evaluate the effect of high dose Renin-Angiotensin System (RAS)-antagonists and beta-blocker treatment for the primary prevention of cardiac events in a population of patients with Type 2 diabetes mellitus (T2DM) with no evidence of a preexisting cardiac disease. An additional aim is to demonstrate an interaction between concentrations of amino-terminal pro-B type natriuretic peptide (NT-proBNP as a surrogate of imminent cardiac risk) and treatment effects and the economic impact of the intervention overall and in the biomarker stratified subgroups. Primary objective Superiority of high dose treatment with RAS-antagonists and beta-blockers compared to conventional therapy regarding the reduction of unplanned hospitalization or death due to a cardiac event in T2DM patients with a NT-proBNP \> 125pg/ml. There is an additional eye-substudy for Viennese sites only. The purpose of this sub-study is to evaluate the effect of high dose RAS-antagonists and beta blocker treatment on early subclinical signs of diabetic micro-angiopathy and neuropathy. An additional aim will be the evaluation of the possible impact of the cardiovascular risk factor NT-proBNP on the onset and progression of diabetic retinopathy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Type-2 diabetes for at least six months,

• ≥ 18 years of age, men or female,

• Written informed consent to participate in the study and ability to comply with all requirements.

• Participation in the PONTIAC 2 Study

• Written informed consent to participate in the eye-study

Locations
Other Locations
Austria
Klinischen Abteilung für Endokrinologie und Diabetologie MU Graz
RECRUITING
Graz
Konventhospital der Barmherzigen Brüder Abteilung für Innere Medizin
RECRUITING
Linz
Internistische Ordination
ACTIVE_NOT_RECRUITING
Mödling
3. Med. Abtlg., KH Hietzing mit Neurologischem Zentrum Rosenhügel
TERMINATED
Vienna
Diabetes & Stoffwechselambulanz Gesundheitszentrum Wien Süd
RECRUITING
Vienna
iMED19
RECRUITING
Vienna
Krankenanstalt Rudolfstiftung, 1. Medizinische Abteilung
COMPLETED
Vienna
Medical University of Vienna Univ.Clinic for Internal Medicine II Department of Cardiology
RECRUITING
Vienna
Univ. Klinik für Innere Medizin III Med. Uni Wien
RECRUITING
Vienna
Universitätsklinik für Augenheilkunde und Optometrie Medizinische Universität Wien
RECRUITING
Vienna
Zentrum für Klinische Studien
TERMINATED
Vienna
Netherlands
Maastricht University Medical Center; Dep. Cardiology
ACTIVE_NOT_RECRUITING
Maastricht
New Zealand
Christchurch Heart Institute
RECRUITING
Christchurch
Spain
Hospital de la Santa Creu i Sant Pau, Unitat de Diabetis, Servei d'Endocrinologia i Nutrició, Universitat Autònoma de Barcelona
RECRUITING
Barcelona
Hospital Universitari Germans Trias i Pujol, l'Institut del Cor
RECRUITING
Barcelona
United Kingdom
Ninewells Hospital, Diabetes Support Unit
RECRUITING
Dundee
Queen Elisabeth University Hospital, Glasgow Clinical Research Facility
RECRUITING
Glasgow
North Manchester General Hospital, Diabetes centre
RECRUITING
Manchester
Ecclesfield Group Practice
ACTIVE_NOT_RECRUITING
Sheffield
Nethergreen Surgery
ACTIVE_NOT_RECRUITING
Sheffield
Woodseats Medical Centre
ACTIVE_NOT_RECRUITING
Sheffield
Contact Information
Primary
Martin Huelsmann, Doz.Dr.
martin.huelsmann@meduniwien.ac.at
+43 1 40400
Time Frame
Start Date: 2016-02
Estimated Completion Date: 2026-12
Participants
Target number of participants: 2400
Treatments
Experimental: Intensive therapy
RAS-antagonist and beta-blocker up-to maximal dosages as permitted and tolerated and following national guidelines.
Other: Conventional therapy
No RAS-antagonist and beta-blocker or at stable dose as per study entrance. Changes in RAS-antagonist or beta-blocker therapy are not allowed in the control group during the study phase.
Sponsors
Leads: Martin Huelsmann

This content was sourced from clinicaltrials.gov