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Prevention of heart disease in heart-healthy patients with diabetes based on a special parameter (NT-proBNP)
EU CTIS ID: 2024-519051-28-01
What this study is testing
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. Co-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 in the whole population.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Type-2 diabetes mellitus 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
You likely can't join if
- 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
- Patients already receiving a maximum dose of RAAS-antagonists or beta-blocker
- Creatinine>2.5mg/dl
- Symptomatic hypotension and/or systolic blood pressure(SBP) <100mmHg at visit 1
- Symptomatic bradycardia and/or heart rate (HR)<60bpm at visit 1
- Signs of cardiac disease in the electrocardiogram, such as atrial fibrillation, ST-T abnormalities, or a bundle branch block/ higher degree AV block
See the full eligibility criteria
- Type-2 diabetes mellitus 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
- 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
- Patients already receiving a maximum dose of RAAS-antagonists or beta-blocker
- Creatinine>2.5mg/dl
- Symptomatic hypotension and/or systolic blood pressure(SBP) <100mmHg at visit 1
- Symptomatic bradycardia and/or heart rate (HR)<60bpm at visit 1
- Signs of cardiac disease in the electrocardiogram, such as atrial fibrillation, ST-T abnormalities, or a bundle branch block/ higher degree AV block
- Abnormal echocardiography, defined as low ejection fraction <50%; wall motion abnormalities suggesting coronary artery disease (CAD), significant valve dysfunction > grades I.
- 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
- A disease other than diabetes lowering the patient’s life expectancy to less than two years.
- Exclusion criteria specific for Spain only
- Chronic infections or malignancies
- Systemic treatment with corticosteroids
- Renal replacement therapy
- 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.
- 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).
- History of noncompliance to medical regimes and patients who are considered potentially unreliable
- Current double blind treatment in diabetic trials
- Participation in an investigational drug study at the time of enrollment or within the past 90 days.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.