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Preventing heart events in diabetic patients using specific medications

NT-proBNP Selected PreventiOn of Cardiac eveNts in a populaTion of dIabetic Patients Without A History of Cardiac Disease: a Prospective Randomized Trial

Phase 4 Interventional Medical University of Vienna · NCT02817360

This study tests whether high doses of certain heart medications can help prevent heart problems in people with Type 2 diabetes who don’t already have heart disease.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment2400 (estimated)
Ages18 Years and up
SexAll
SponsorMedical University of Vienna Academic / other
Locations21 sites (Mödling, Lower Austria and 20 other locations)
Trial IDNCT02817360 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of high-dose Renin-Angiotensin System (RAS)-antagonists and beta-blockers for preventing cardiac events in patients with Type 2 diabetes who do not have preexisting heart disease. It aims to compare these treatments to conventional therapy, focusing on patients with elevated levels of NT-proBNP, a biomarker indicating cardiac risk. The study also investigates the economic impact of the intervention and how treatment effects may vary based on NT-proBNP concentrations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with Type 2 diabetes for at least six months and no history of cardiac disease.

Not a fit: Patients with existing cardiac conditions or those already on maximum doses of the study medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the risk of cardiac events in diabetic patients, potentially saving lives and reducing hospitalizations.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this area.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Type-2 diabetes for at least six months,
2. ≥ 18 years of age, men or female,
3. Written informed consent to participate in the study and ability to comply with all requirements.

Exclusion Criteria:

1. History of hypersensitivity to any of the investigated drugs as well as known or suspected contraindications to the study drugs or previous history of intolerance to high dose of RAS-Antagonist or Beta-blocker in the absence of any other blood pressure lowering drugs.
2. Patients already on maximum dose of RAS-antagonist or beta-blocker.
3. Creatinine \> 2.5mg/dl.
4. Symptomatic hypotension and/or systolic blood pressure (SBP) \< 100 mmHg at Visit 1.
5. Symptomatic bradycardia and/or heart rate (HR) \< 60 bpm at Visit 1
6. Signs of cardiac disease in the ECG such as atrial fibrillation; ST-T abnormalities or any bundle branch block / higher degree atrioventricular (AV) block.
7. Abnormal echocardiography, defined as low ejection fraction \< 50%; wall motion abnormalities suggesting coronary artery disease (CAD), significant valve dysfunction \> grade I or other significant alteration.
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 T2DM 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 \> 40 mIU/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 (\> 5 U/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.

Eligibility criteria for eye-substudy:

Inclusion criteria:

1. Participation in the PONTIAC 2 Study
2. Written informed consent to participate in the eye-study

Exclusion criteria:

1. Media opacities like cataract or vitreous hemorrhage
2. Active intraocular inflammation (grade trace or above) in either eye like infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye
3. Structural damage to the center of macula in the study eye
4. Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques
5. Ocular disorders in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization, macula dystrophies
6. Intraocular surgery (including cataract surgery, Yttrium-Aluminium-Granat (YAG) laser capsulotomy) in the study eye within 3 months preceding Day 0
7. Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)
8. History of glaucoma filtration surgery, corneal transplantation in the study eye
9. Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded
10. History of epilepsy

Where this trial is running

Mödling, Lower Austria and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart DiseasesDiabetes Mellitus, Type 2
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.