A clinical study to investigate the use of commonly used heart failure medicines in the prevention of heart related illnesses in patients with diabetes mellitus but without heart disease.
- Conditions
- Type 2 diabetes mellitusMedDRA version: 20.0 Level: LLT Classification code 10052912 Term: Cardiovascular disorder prophylaxis System Organ Class: 100000004865MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2015-000239-34-GB
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 2400
1) Type-2 diabetes mellitus - diagnosed for at least six months prior to inclusion
2) = 18 years of age, male or female
3) Written informed consent to participate in the study and ability to comply with the study requirements.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
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) 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.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method