Clinical Trial Details
| Trial ID: | L5863 |
| Source ID: | NCT02817360 |
| Associated Drug: | Ras-Antagonist And Beta-Blocker Up-To Maximal Dosages |
| Title: | NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients |
| Acronym: | |
| Status: | RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | Heart Diseases|Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: RAS-antagonist and beta-blocker up-to maximal dosages|OTHER: RAS-antagonist and beta-blocker none or at stable dose |
| Outcome Measures: | Primary: Number of patients with an unplanned cardiac hospitalization or death due to a cardiac event, The combined endpoint of the number of patients with an unplanned cardiac hospitalization or death due to a cardiac event will be recorded throughout the study duration of 2 years., 2 years | Other: Number of patients hospitalised due to any cardiac reasons, The number of subjects who were hospitalised due to any cardiac reasons will recorded., 2 years|Number of patients hospitalised due to heart failure, The number of subjects who were hospitalised due to a heart failure will recorded., 2 years|Number of patients hospitalised due to all causes, The number of subjects who were hospitalised due to any cause, 2 years|Change of kidney function, Change of kidney function measured by eGFR (estimated glomerular filtration rate), 2 years |
| Sponsor/Collaborators: | Sponsor: Martin Huelsmann |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 2400 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2016-02 |
| Completion Date: | 2026-12 |
| Results First Posted: | |
| Last Update Posted: | 2023-03-14 |
| Locations: | Internistische Ordination, Mödling, Niederösterreich, 2340, Austria|Klinischen Abteilung für Endokrinologie und Diabetologie MU Graz, Graz, Steiermark, 8036, Austria|Konventhospital der Barmherzigen Brüder Abteilung für Innere Medizin, Linz, Upper Austria, 4021, Austria|Krankenanstalt Rudolfstiftung, 1. Medizinische Abteilung, Vienna, 1030, Austria|Medical University of Vienna Univ.Clinic for Internal Medicine II Department of Cardiology, Vienna, 1090, Austria|Univ. Klinik für Innere Medizin III Med. Uni Wien, Vienna, 1090, Austria|Universitätsklinik für Augenheilkunde und Optometrie Medizinische Universität Wien, Vienna, 1090, Austria|Diabetes & Stoffwechselambulanz Gesundheitszentrum Wien Süd, Vienna, 1100, Austria|3. Med. Abtlg., KH Hietzing mit Neurologischem Zentrum Rosenhügel, Vienna, 1130, Austria|iMED19, Vienna, 1190, Austria|Zentrum für Klinische Studien, Wien, 1060, Austria|Maastricht University Medical Center; Dep. Cardiology, Maastricht, 6202, Netherlands|Christchurch Heart Institute, Christchurch, 8140, New Zealand|Hospital de la Santa Creu i Sant Pau, Unitat de Diabetis, Servei d'Endocrinologia i Nutrició, Universitat Autònoma de Barcelona, Barcelona, 8025, Spain|Hospital Universitari Germans Trias i Pujol, l'Institut del Cor, Barcelona, 8916, Spain|Ninewells Hospital, Diabetes Support Unit, Dundee, DD19SY, United Kingdom|Queen Elisabeth University Hospital, Glasgow Clinical Research Facility, Glasgow, G514TF, United Kingdom|North Manchester General Hospital, Diabetes centre, Manchester, M85RB, United Kingdom|Nethergreen Surgery, Sheffield, S117EJ, United Kingdom|Ecclesfield Group Practice, Sheffield, S359XQ, United Kingdom|Woodseats Medical Centre, Sheffield, S8OSH, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT02817360 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|