Prevention of heart disorders in diabetic patients on the basis of NT-proBNP values.

Phase 1

• Conditions: 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.; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-000239-34-ES
• Lead Sponsor: Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-30
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

1)Type-2 diabetes mellitus for at least six months,
2)> or = 18 years of age, men or female,
3)Written informed consent to participate in the study and ability to comply with all requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

1)History of hypersensitivity to any of the drugs investigated as well as known or suspected contraindications to the study drugs or previous history of intolerance to high dose of RAAS-antagonists or beta-blocker in the absence of any other blood pressure lowering drugs.
2)Patients already receiving a maximum dose of RAAS-antagonists or beta-blocker.
3)Creatinine > 2.5mg/dl.
4)Symptomatic hypotension and/or systolic blood pressure (SBP) < 100mmHg at visit 1.
5)Symptomatic bradycardia and/or heart rate (HR) < 60bpm at visit 1.
6)Signs of cardiac disease in the electrocardiogram such as atrial fibrillation; ST-T abnormalities or a bundle branch block/ higher degree AV block.
7)Abnormal echocardiography, defined as low ejection fraction < 50%; wall motion abnormalities suggesting coronary artery disease (CAD), significant valve dysfunction > grades I.
8)Coronary artery disease, defined by a history of myocardial infarction, known coronary stenosis > 70% detected either by angiography or by CT-scan, significant defects in myocardial scintigraphy or positive stress-test echocardiography.
9)A disease other than diabetes lowering the patient’s life expectancy to less than two years.
10)Chronic infections or malignancies.
11)Systemic treatment with corticosteroids.
12)Renal replacement therapy.
13) Global criterion (not applicable to Spain): Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels >40mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy
OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, and oral), and double-barrier methods (if accepted by local regulatory authority and ethics committee). Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
Criterion specific for Spain: Women of child-bearing potential (WOCBP) will not be recruited in any case in Spain.
14)Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin (hCG) laboratory test ( > 5mIU/ml).
15)History of noncompliance to medical regimes and patients who are considered potentially unreliable.
16)Current double blind treatment in diabetic trials.
17)Participation in an investigational drug study at the time of enrollment or within the past 90 days.
18) Criterion specific for Spain: Subjects to whom participation in this study may involve an expense beyond their means in case that their Social Security affiliation scheme does not fully cover the medication that is prescribed in the context of the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified