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NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients

Primary Purpose

Heart Diseases, Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
RAS-antagonist and beta-blocker up-to maximal dosages
RAS-antagonist and beta-blocker none or at stable dose
Sponsored by
Martin Huelsmann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Internistische Ordination
  • Klinischen Abteilung für Endokrinologie und Diabetologie MU GrazRecruiting
  • Konventhospital der Barmherzigen Brüder Abteilung für Innere MedizinRecruiting
  • Krankenanstalt Rudolfstiftung, 1. Medizinische Abteilung
  • Medical University of Vienna Univ.Clinic for Internal Medicine II Department of CardiologyRecruiting
  • Univ. Klinik für Innere Medizin III Med. Uni WienRecruiting
  • Universitätsklinik für Augenheilkunde und Optometrie Medizinische Universität WienRecruiting
  • Diabetes & Stoffwechselambulanz Gesundheitszentrum Wien SüdRecruiting
  • 3. Med. Abtlg., KH Hietzing mit Neurologischem Zentrum Rosenhügel
  • iMED19Recruiting
  • Zentrum für Klinische Studien
  • Maastricht University Medical Center; Dep. Cardiology
  • Christchurch Heart InstituteRecruiting
  • Hospital de la Santa Creu i Sant Pau, Unitat de Diabetis, Servei d'Endocrinologia i Nutrició, Universitat Autònoma de BarcelonaRecruiting
  • Hospital Universitari Germans Trias i Pujol, l'Institut del CorRecruiting
  • Ninewells Hospital, Diabetes Support UnitRecruiting
  • Queen Elisabeth University Hospital, Glasgow Clinical Research FacilityRecruiting
  • North Manchester General Hospital, Diabetes centreRecruiting
  • Nethergreen Surgery
  • Ecclesfield Group Practice
  • Woodseats Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intensive therapy

Conventional therapy

Arm Description

RAS-antagonist and beta-blocker up-to maximal dosages as permitted and tolerated and following national guidelines.

No RAS-antagonist and beta-blocker or at stable dose as per study entrance. Changes in RAS-antagonist or beta-blocker therapy are not allowed in the control group during the study phase.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 15, 2016
Last Updated
March 12, 2023
Sponsor
Martin Huelsmann
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1. Study Identification

Unique Protocol Identification Number
NCT02817360
Brief Title
NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients
Official Title
NT-proBNP Selected PreventiOn of Cardiac eveNts in a populaTion of dIabetic Patients Without A History of Cardiac Disease: a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Martin Huelsmann

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Purpose and rationale 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. An additional aim is to demonstrate an interaction between concentrations of amino-terminal pro-B type natriuretic peptide (NT-proBNP as a surrogate of imminent cardiac risk) and treatment effects and the economic impact of the intervention overall and in the biomarker stratified subgroups. 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 with a NT-proBNP > 125pg/ml. There is an additional eye-substudy for Viennese sites only. The purpose of this sub-study is to evaluate the effect of high dose RAS-antagonists and beta blocker treatment on early subclinical signs of diabetic micro-angiopathy and neuropathy. An additional aim will be the evaluation of the possible impact of the cardiovascular risk factor NT-proBNP on the onset and progression of diabetic retinopathy.
Detailed Description
Purpose and rationale 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. An additional aim is to demonstrate an interaction between concentrations of amino-terminal pro-B type natriuretic peptide (NT-proBNP as a surrogate of imminent cardiac risk) and treatment effects and the economic impact of the intervention overall and in the biomarker stratified subgroups. 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 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 Secondary objective Dependency of treatment efficacy (reduction of unplanned hospitalization or death due to a cardiac event in T2DM patients) on the NT-proBNP concentration (interaction effect between NT-proBNP concentrations and treatment). Population The study population will consist of patients with T2DM without any history or signs of cardiac disease. Patients from approximately 20 centers worldwide will be included into the study and randomized 1:1 to intensive or conventional therapy. It is estimated that about 3000 patients have to be screened In order to include 2400 patients. The screen failure rate is anticipated to be approximately 20%. Investigational and reference therapy All eligible patients will be randomized to receive either a high dose of RAS-antagonists and beta-blockers (as defined in the section investigational drugs) on top of standard diabetes therapy or solely standard diabetes therapy. The use of RAS-antagonist and beta-blocker therapy at randomization is allowed in the control group (with the exception of maximal dosage), but prescription or titration during the study period is not encouraged. However, if the investigators feel that further prescription or up-titration is required a thorough justification is mandatory. Every attempt should be made to use other blood pressure lowering drugs than RAS-antagonists or beta-blockers in the control group. Study design This study is a randomized open-label, parallel group, active-controlled, two-arm, long-term morbidity and mortality trial to evaluate the efficacy and safety of high dose RAS-antagonist and beta-blocker therapy (as defined in the section investigational drugs) compared to standard diabetes therapy in patients with diabetes without any history or sign of a cardiac disease. The goal is to include 2400 patients. The observation period is planned to last for two years. However, the trial is event driven and will continue until predefined event rate is reached. The total trial duration is expected to last for four years (two years of recruitment and a two year observation period after last patient in). Every patient will remain in the study for two years after randomization. Visit 1 Screening At the first visit eligibility to enter the study will be assessed by the investigator. All inclusion/exclusion criteria will be evaluated. Informed consent will be obtained. Demographic data and drug prescription will be assessed. Blood will be obtained. Blood chemistry will be assessed locally. NT-proBNP will be determined by a point of care system locally. The investigator will be blinded to the result, which will be sent to the central computer. Blood will be obtained for the core lab, centrifuged and stored at -80° Celsius at the local unit. Vital signs will be obtained. Randomization will be performed electronically, this way randomization can be performed immediately. Visit 2 (3 months) At visit 2 vital signs will be obtained. Blood will be drawn. Blood chemistry parameters will be assessed locally for safety reason. Drug prescription will be documented. Visit 3 (12 months) At visit 3 vital signs will be obtained. Blood will be drawn. Blood chemistry parameters will be assessed locally for safety reason. Drug prescription will be documented. Visit 4 EOS (end of study) (24 months) At visit 4 vital signs will be obtained. Blood will be drawn. Blood chemistry parameters will be assessed locally for safety reason. Additional blood samples will be sent to the core laboratory. Drug prescription will be documented. Visit 1-4 is mandatory for all patients. Long-term follow-up Patients with be further followed by population register or telephone contact respectively until completion of the study to determine long-term mortality and hospitalizations. Unscheduled visits for the treatment group The treatment group will have additional visits for up-titration of RAS-antagonists and beta- blocker between visit 1 and visit 2. The frequency is up to the treating physician and dependent on the titration steps. A visit is not mandatory for each titration step. Patients will receive a logbook by the investigator, with weekly up- titration steps of the drugs. Additionally, patients will receive a diary for daily documentation of blood pressure, heart rate and symptoms if measurement is technically feasible for the patient. Based on own measurements, these data and laboratory results the investigator will decide if further up-titration of medication is possible. Systolic blood pressure should not decrease permanently below 100 mmHg and heart not below 60bpm permanently. Recommended drugs and recommended dosages are outlined in the section "Treatment". At each visit, blood chemistry for eGFR, creatinine, blood urea nitrogen (BUN), sodium and potassium will be obtained for safety reason. Details of the eye-substudy: The PONTIAC Eye Study is a masked longitudinal follow up of previously 1:1 randomized study patients participating in the PONTIAC 2 study. It is planed to include 130 consecutive patients for biannually visits over a study period of 2 years. Study patients (n=130) will be assigned to the Department of Ophthalmology and Optometry of the Medical University Vienna once they are included in the PONTIAC 2 Study in one of the participating Centers in Vienna. The investigators will be masked to the patient's randomization. The primary objective of the sub-study is: Superiority of the treatment arm with RAS-antagonists and beta-blockers compared to conventional therapy regarding thickness-change in the retinal nerve fiber layer or outer nuclear layer measured in spectral domain optical coherence tomography.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive therapy
Arm Type
Experimental
Arm Description
RAS-antagonist and beta-blocker up-to maximal dosages as permitted and tolerated and following national guidelines.
Arm Title
Conventional therapy
Arm Type
Other
Arm Description
No RAS-antagonist and beta-blocker or at stable dose as per study entrance. Changes in RAS-antagonist or beta-blocker therapy are not allowed in the control group during the study phase.
Intervention Type
Drug
Intervention Name(s)
RAS-antagonist and beta-blocker up-to maximal dosages
Other Intervention Name(s)
Enalapril 40mg/d, Ramipril 10mg/d, Lisinopril 40mg/d, Cilazapril 5mg/d, Perindopril 8mg/d, Captopril 150mg/d, Spirapril 24mg/d, Quinapril 40mg/d, Trandolapril 4mg/d, Zofenopril 60mg/d, Fosinopril 40mg/d, Candesartan 32mg/d, Valsartan 320mg/d, Irbesartan 300mg/d, Losartan 150mg/d, Eprosartan 800mg/d, Bisoprolol 10mg/d, Metoprololsuccinat 200mg/d, Carvedilol 50mg/d (100mg/d if weight is > 85kg), Nebivolol 10mg/d
Intervention Description
All patients have to be stable on their glucose lowering, lipid lowering and blood pressure lowering therapy at least for 3 months. RAS-antagonist and beta-blocker therapy at entrance is allowed. Patients receive a prescription and/or up-titration to maximum recommended or tolerated dose of RAS-antagonist and beta-blockers within three months of study entry. The Number of titration visits is up to the treating physician, but one visit should be performed at least at the end of titration.
Intervention Type
Other
Intervention Name(s)
RAS-antagonist and beta-blocker none or at stable dose
Intervention Description
All patients have to be stable on their glucose lowering, lipid lowering and blood pressure lowering therapy at least for 3 months. RAS-antagonist and beta-blocker therapy at entrance is allowed. Changes in RAS-antagonist or beta-blocker therapy are not allowed in the control group during the study phase. If there is a vital indication for changes, this has to be argued and documented.
Primary Outcome Measure Information:
Title
Number of patients with an unplanned cardiac hospitalization or death due to a cardiac event
Description
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.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Number of patients hospitalised due to any cardiac reasons
Description
The number of subjects who were hospitalised due to any cardiac reasons will recorded.
Time Frame
2 years
Title
Number of patients hospitalised due to heart failure
Description
The number of subjects who were hospitalised due to a heart failure will recorded.
Time Frame
2 years
Title
Number of patients hospitalised due to all causes
Description
The number of subjects who were hospitalised due to any cause
Time Frame
2 years
Title
Change of kidney function
Description
Change of kidney function measured by eGFR (estimated glomerular filtration rate)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type-2 diabetes 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. Exclusion Criteria: 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. Patients already on maximum dose of RAS-antagonist or beta-blocker. Creatinine > 2.5mg/dl. Symptomatic hypotension and/or systolic blood pressure (SBP) < 100 mmHg at Visit 1. Symptomatic bradycardia and/or heart rate (HR) < 60 bpm at Visit 1 Signs of cardiac disease in the ECG such as atrial fibrillation; ST-T abnormalities or any bundle branch block / higher degree atrioventricular (AV) block. 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. 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 T2DM lowering the patient's life expectancy to less than two years. 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 > 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. 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). 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. Eligibility criteria for eye-substudy: Inclusion criteria: Participation in the PONTIAC 2 Study Written informed consent to participate in the eye-study Exclusion criteria: Media opacities like cataract or vitreous hemorrhage 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 Structural damage to the center of macula in the study eye Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques Ocular disorders in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization, macula dystrophies Intraocular surgery (including cataract surgery, Yttrium-Aluminium-Granat (YAG) laser capsulotomy) in the study eye within 3 months preceding Day 0 Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication) History of glaucoma filtration surgery, corneal transplantation in the study eye Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded History of epilepsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Huelsmann, Doz.Dr.
Phone
+43 1 40400
Ext
46140
Email
martin.huelsmann@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Huelsmann, Doz.Dr.
Organizational Affiliation
Univ.Clinic II, Medical University Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Internistische Ordination
City
Mödling
State/Province
Niederösterreich
ZIP/Postal Code
2340
Country
Austria
Individual Site Status
Active, not recruiting
Facility Name
Klinischen Abteilung für Endokrinologie und Diabetologie MU Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harald Sourij
Phone
+43-316-385-80363
Email
ha.sourij@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Michael Zink
Phone
+43-680-128-5120
Email
m.zink@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Julia Mader, MD Prof
First Name & Middle Initial & Last Name & Degree
Eva Novak, MD
First Name & Middle Initial & Last Name & Degree
Caren Sourij, MD
Facility Name
Konventhospital der Barmherzigen Brüder Abteilung für Innere Medizin
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4021
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Clodi, Prof.Dr.
Email
martin.clodi@bblinz.at
First Name & Middle Initial & Last Name & Degree
Martin Clodi, Prof.Dr.
First Name & Middle Initial & Last Name & Degree
Michael Resl, Dr.
Facility Name
Krankenanstalt Rudolfstiftung, 1. Medizinische Abteilung
City
Vienna
ZIP/Postal Code
1030
Country
Austria
Individual Site Status
Completed
Facility Name
Medical University of Vienna Univ.Clinic for Internal Medicine II Department of Cardiology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Huelsmann, Doz.Dr.
Phone
+43 1 40400
Ext
46140
Email
martin.huelsmann@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Martin Huelsmann, Doz.Dr.
First Name & Middle Initial & Last Name & Degree
Raphael Wurm, Dr.
Facility Name
Univ. Klinik für Innere Medizin III Med. Uni Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Kautzky-Willer, Prof.Dr.
Phone
00 43 1 40400
Ext
43100
Email
alexandra.kautzky-willer@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Alexandra Kautzky-Willer, Prof.Dr.
First Name & Middle Initial & Last Name & Degree
Michael Krebs, Prof.Dr.
Facility Name
Universitätsklinik für Augenheilkunde und Optometrie Medizinische Universität Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonja Karst, Dr.
Phone
+43 1 40400
Ext
79470
Email
sonja.karst@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Sonja Karst (prev. Prager), Dr.
First Name & Middle Initial & Last Name & Degree
Julia Aschauer (prev. Hafner), Dr.
Facility Name
Diabetes & Stoffwechselambulanz Gesundheitszentrum Wien Süd
City
Vienna
ZIP/Postal Code
1100
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helmut Brath, OA Dr.
Phone
+43 1 60122
Ext
4264
Email
helmut.brath@wgkk.at
First Name & Middle Initial & Last Name & Degree
Helmut Brath, OA Dr.
Facility Name
3. Med. Abtlg., KH Hietzing mit Neurologischem Zentrum Rosenhügel
City
Vienna
ZIP/Postal Code
1130
Country
Austria
Individual Site Status
Terminated
Facility Name
iMED19
City
Vienna
ZIP/Postal Code
1190
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Adlbrecht, PD Dr.
Email
c.adlbrecht@imed19.at
Facility Name
Zentrum für Klinische Studien
City
Wien
ZIP/Postal Code
1060
Country
Austria
Individual Site Status
Terminated
Facility Name
Maastricht University Medical Center; Dep. Cardiology
City
Maastricht
ZIP/Postal Code
6202
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Christchurch Heart Institute
City
Christchurch
ZIP/Postal Code
8140
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Troughton, MD Prof
Phone
+64 3 364 1063
Email
Richard.Troughton@cdhb.health.nz
First Name & Middle Initial & Last Name & Degree
Lorraine Skelton
Phone
+64 3 364 1063
Email
lorraine.skelton@cdhb@health.nz
First Name & Middle Initial & Last Name & Degree
Richard Troughton, MD Prof
Facility Name
Hospital de la Santa Creu i Sant Pau, Unitat de Diabetis, Servei d'Endocrinologia i Nutrició, Universitat Autònoma de Barcelona
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Corcoy, MD Prof
Email
RCorcoy@santpau.cat
Facility Name
Hospital Universitari Germans Trias i Pujol, l'Institut del Cor
City
Barcelona
ZIP/Postal Code
8916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoni Bayes-Genis, MD Prof
Email
abayesgenis@gmail.com
Facility Name
Ninewells Hospital, Diabetes Support Unit
City
Dundee
ZIP/Postal Code
DD19SY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rory McCrimmon, MD Prof
Email
r.mccrimmon@dundee.ac.uk
Facility Name
Queen Elisabeth University Hospital, Glasgow Clinical Research Facility
City
Glasgow
ZIP/Postal Code
G514TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierpaolo Pellicori, MD Prof
Email
pierpaolo.pellicori@glasgow.ac.uk
Facility Name
North Manchester General Hospital, Diabetes centre
City
Manchester
ZIP/Postal Code
M85RB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cuong Dang, MD Prof
Email
Cuong.dang@mft.nhs.uk
Facility Name
Nethergreen Surgery
City
Sheffield
ZIP/Postal Code
S117EJ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Ecclesfield Group Practice
City
Sheffield
ZIP/Postal Code
S359XQ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Woodseats Medical Centre
City
Sheffield
ZIP/Postal Code
S8OSH
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients

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