Actively Recruiting
NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients
Led by Martin Huelsmann · Updated on 2023-03-14
2400
Participants Needed
21
Research Sites
565 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Type 2 diabetes for at least six months
- 18 years of age or older, any gender
- Written informed consent and ability to follow study requirements
You will not qualify if you...
- Allergy or intolerance to study drugs or previous intolerance to high-dose RAS-antagonists or beta-blockers without other blood pressure drugs
- Currently on maximum dose of RAS-antagonist or beta-blocker
- Creatinine level greater than 2.5 mg/dl
- Symptomatic low blood pressure or systolic blood pressure below 100 mmHg at screening
- Symptomatic slow heart rate or heart rate below 60 bpm at screening
- Signs of heart disease on ECG, such as atrial fibrillation, ST-T changes, or heart block
- Abnormal heart ultrasound with low ejection fraction below 50%, wall motion abnormalities, significant valve problems, or other significant changes
- History of coronary artery disease including heart attack or significant artery narrowing
- Other diseases expected to reduce life expectancy to less than two years
- Chronic infections or cancers
- Current systemic corticosteroid treatment
- Receiving renal replacement therapy
- Women capable of becoming pregnant unless post-menopausal or using reliable contraception
- Pregnant or breastfeeding women
- History of not following medical treatments or considered unreliable
- Currently in other blinded diabetes trials
- Participation in another drug study within the past 90 days
AI-Screening
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Trial Site Locations
Total: 21 locations
1
Internistische Ordination
Mödling, Lower Austria, Austria, 2340
Active, Not Recruiting
2
Klinischen Abteilung für Endokrinologie und Diabetologie MU Graz
Graz, Styria, Austria, 8036
Actively Recruiting
3
Konventhospital der Barmherzigen Brüder Abteilung für Innere Medizin
Linz, Upper Austria, Austria, 4021
Actively Recruiting
4
Krankenanstalt Rudolfstiftung, 1. Medizinische Abteilung
Vienna, Austria, 1030
Completed
5
Zentrum für Klinische Studien
Vienna, Austria, 1060
Terminated
6
Medical University of Vienna Univ.Clinic for Internal Medicine II Department of Cardiology
Vienna, Austria, 1090
Actively Recruiting
7
Univ. Klinik für Innere Medizin III Med. Uni Wien
Vienna, Austria, 1090
Actively Recruiting
8
Universitätsklinik für Augenheilkunde und Optometrie Medizinische Universität Wien
Vienna, Austria, 1090
Actively Recruiting
9
Diabetes & Stoffwechselambulanz Gesundheitszentrum Wien Süd
Vienna, Austria, 1100
Actively Recruiting
10
3. Med. Abtlg., KH Hietzing mit Neurologischem Zentrum Rosenhügel
Vienna, Austria, 1130
Terminated
11
iMED19
Vienna, Austria, 1190
Actively Recruiting
12
Maastricht University Medical Center; Dep. Cardiology
Maastricht, Netherlands, 6202
Active, Not Recruiting
13
Christchurch Heart Institute
Christchurch, New Zealand, 8140
Actively Recruiting
14
Hospital de la Santa Creu i Sant Pau, Unitat de Diabetis, Servei d'Endocrinologia i Nutrició, Universitat Autònoma de Barcelona
Barcelona, Spain, 8025
Actively Recruiting
15
Hospital Universitari Germans Trias i Pujol, l'Institut del Cor
Barcelona, Spain, 8916
Actively Recruiting
16
Ninewells Hospital, Diabetes Support Unit
Dundee, United Kingdom, DD19SY
Actively Recruiting
17
Queen Elisabeth University Hospital, Glasgow Clinical Research Facility
Glasgow, United Kingdom, G514TF
Actively Recruiting
18
North Manchester General Hospital, Diabetes centre
Manchester, United Kingdom, M85RB
Actively Recruiting
19
Nethergreen Surgery
Sheffield, United Kingdom, S117EJ
Active, Not Recruiting
20
Ecclesfield Group Practice
Sheffield, United Kingdom, S359XQ
Active, Not Recruiting
21
Woodseats Medical Centre
Sheffield, United Kingdom, S8OSH
Active, Not Recruiting
Research Team
M
Martin Huelsmann, Doz.Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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