Arterial CalcificationACCEPTNCT04114695
Aortic Calcification and Central Blood Pressure in Patients With Chronic Kidney Disease
An observational study of Arterial Calcification and Kidney Diseases, run by Central Jutland Regional Hospital at 1 site in Denmark.
Trial summary
Aim and background: This study will seek to identify physiological and biochemical factors explaining and predicting a higher than expected central (aortic) blood pressure (BP) in patients with chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Calcification, Kidney Diseases, Coronary Artery Disease
- How many people
- 185 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Oct 2019to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for CAG can be included in the study if they satisfy all inclusion criteria and do not meet any exclusion criteria. The study cohort will consist of: 1. 160 patients with CKD at various stages based on estimated glomerular filtration rate (eGFR): 40 patients in stage 3a (eGFR 45-59 ml/min/1,73 m2), 40 patients in stage 3b (30-44 ml/min/1,73 m2), 40 patients in stage 4 (15-29 ml/min/1,73 m2) and 40 in stage 5 (<15 ml/min/1,73 m2). The stage 5 patients will be distributed between non-dialysis and dialysis patients. 2. 40 patients with renal function considered normal for age (eGFR ≥60 ml/min/1.73 m2) without proteinuria or structural kidney disease.
Who may be able to join
- Age >18 years
- Patient referred for planned CAG at the Department of Cardiology, Aarhus University Hospital (AUH)
- eGFR constantly either >60 ml/min or <60 ml/min in at least 2 separate blood-sample measurements over at least 3 months.
- Signed informed consent-form.
Who cannot join
- Antihypertensive treatment changed within the last two weeks prior to the CAG.
- Severe aortic valve stenosis (<1 cm) as central hemodynamics may be altered
- Maximum number of patients in CKD-group already reached.
- Atrial fibrillation or other cardiac arrhythmia making radial Pulse Wave Analysis (PWA) estimations impossible.
- Known significant stenosis of a. subclavia or a. brachialis
- Bilateral arteriovenous-fistula (even if one or both of these have been surgically removed) as this may significantly affect the pulse-wave form.
Trial locations and contacts
1 site in 1 country.
About this study
Aim and background:
This study will seek to identify physiological and biochemical factors explaining and predicting a higher than expected central (aortic) blood pressure (BP) in patients with chronic kidney disease (CKD). The basic hypothesis of the study is that the degree of aortic calcification is an important component of elevated central BP, which, in turn, is important for the organ-damage and increased risk of cardiovascular disease associated with CKD.
Read more
Methods:
Adult patients with varying degrees of CKD undergoing scheduled coronary angiography (CAG) at Aarhus University Hospital will be included in this study.
During the CAG procedure, systolic and diastolic BP is determined in the ascending part of aorta by a calibrated pressure transducer connected to the fluid-filled CAG catheter.
Simultaneous with the registration of invasive aortic BP, estimation of central BP is performed using radial artery tonometry (SphygmoCor®), while a corresponding brachial BP is also measured.
Prior to the CAG, a non-contrast CT scan of aorta in its entirety will be performed to enable blinded quantification of calcification in the wall of aorta and coronary arteries.
Furthermore, echocardiography, resting BP measurement and a range of blood- and urine samples will be performed.
- Conditions
- Arterial Calcification, Kidney Diseases, Coronary Artery Disease, Aortic Calcification, Stroke, Vascular Diseases
- Medical subject headings
- Kidney Diseases, Coronary Artery Disease, Stroke, Vascular Diseases, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-CKD (eGFR >60 ml/min/1.73 m2) | Patients with renal function considered normal for age (eGFR >60 ml/min/1.73 m2) without proteinuria or structural kidney disease. | |
| CKD stage 3a (eGFR 45-59 ml/min/1,73 m2) | Patients with CKD stage 3a (eGFR 45-59 ml/min/1,73 m2) | |
| CKD stage 3b (eGFR 30-44 ml/min/1,73 m2) | Patients with CKD stage 3b (eGFR 30-44 ml/min/1,73 m2) | |
| CKD stage 4 (eGFR 15-29 ml/min/1,73 m2) | Patients with CKD stage 4 (eGFR 15-29 ml/min/1,73 m2) | |
| CKD stage 5 (eGFR <15 ml/min/1,73 m2) | Patients with CKD stage 5 (eGFR <15 ml/min/1,73 m2). 50% of these patients will be in dialysis, while the other 50% will be pre-dialysis patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between directly measured and estimated aortic (central) systolic blood pressure and the corresponding brachial systolic blood pressure
Systolic arterial pressure will be determined in the ascending part of aorta using a calibrated pressure transducer connected to the CAG catheter. Simultaneous measurement with af Oscillometric BP-device (Microlife A2 Basic) will be conducted. The difference in mmHg will be calculated.
Measured: During the CAG-procedure
The degree of aortic calcification
The degree of calcification in the wall of the ascending, arcus, descending and abdominal aorta will be measured with a non-contrast CT scan. Agatston-scoring will be applied on the CT images 2 cm after the aortic valve to the aortic bifurcation to ensure that aortic valve calcification is not included in the score. All Agatston scoring will be performed by a radiologist blinded to information on patient biochemical characteristics.
Measured: CT-scan will be performed prior to CAG if logistically possible and no later than 3 weeks after CAG. All Agatston scoring will be completed when all patients have been included in the study during the summer of 2021.
The difference between directly measured and estimated aortic (central) diastolic blood pressure and the corresponding brachial diastolic blood pressure.
Diastolic arterial pressure will be determined in the ascending part of aorta using a calibrated pressure transducer connected to the CAG catheter. Simultaneous measurement with af Oscillometric BP-device (Microlife A2 Basic) will be conducted. The difference in mmHg will be calculated.
Measured: During the CAG procedure
Secondary outcomes (27)
Association between Matrix Gla Protein (MGP) and aortic calcification
To establish a deeper understanding of the pathogenesis of central arterial calcification in CKD, MGP, a novel biochemical marker of arterial calcification, will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between Calcification propensity score (T50test) and aortic calcification
To establish a deeper understanding of the pathogenesis of central arterial calcification in CKD Calcification propensity score (T50test) will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between sRANKL (soluble receptor activator of nuclear factor kappa-B ligand) and aortic calcification
To establish a deeper understanding of the pathogenesis of central arterial calcification in CKD sRANKL (soluble receptor activator of nuclear factor kappa-B ligand) will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between 25-OH-Vitamin D(D3+D2) and aortic calcification
To establish a deeper understanding of the pathogenesis of central arterial calcification in CKD 25-OH-Vitamin D(D3+D2) will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between Fetuin-A(alfa-2-Heremans Schmid glycoprotein; AHSG) and aortic calcification
To establish a deeper understanding of the pathogenesis of central arterial calcification in CKD Fetuin-A(alfa-2-Heremans Schmid glycoprotein; AHSG) will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021.
Association between Sclerostin and aortic calcification
To establish a deeper understanding of the pathogenesis of central arterial calcification in CKD, Sclerostin will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between osteoprotegerin and aortic calcification
To establish a deeper understanding of the pathogenesis of central arterial calcification in CKD, osteoprotegerin will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between BsAP (bone-specific alkaline phosphatase) and aortic calcification
To establish a deeper understanding of the pathogenesis of central arterial calcification in CKD, BsAP (bone-specific alkaline phosphatase) will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between TRAP5B (tartrate-resistant acid phosphatase 5b) and aortic calcification
To establish a deeper understanding of the pathogenesis of central arterial calcification in CKD, TRAP5B (tartrate-resistant acid phosphatase 5b) will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between P1NP (procollagen type 1 N propeptide) and aortic calcification
To establish a deeper understanding of the pathogenesis of central arterial calcification in CKD, P1NP (procollagen type 1 N propeptide) will be collected and analysed in all patients.
Measured: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between aortic calcification and Left Ventricular Global Longitudinal Strain (GLS) as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association between aortic calcification and LVDd (Left ventricular diameter in diastole) as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association between aortic calcification and IVS (Interventricular septum thickness) as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association between aortic calcification and Two-dimensional automated evaluation of ejection fraction (2-D auto-EF) as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association between aortic calcification and Aorta (sinus) diameter as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association between aortic calcification and Early mitral inflow velocity (E) as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association between aortic calcification and Duration of Pulmonal Vein Reversal as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association between aortic calcification and Late mitral inflow velocity (A) as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association between aortic calcification and Early diastolic mitral annulus velocity (E') as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association between aortic calcification and PW (Posterior wall thickness) as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association between aortic calcification and Aorta (ascendens) diameter as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association between aortic calcification and RVDd (Right ventricular diameter in diastole) as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association between aortic calcification and LAD (Left atrial diameter) as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association between aortic calcification and LAV (Left atrial volume) as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association between aortic calcification and TEI-Index as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association between aortic calcification and Tricuspid annular plane systolic excursion (TAPSE) as determined during echocardiography.
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. As scans will be supervised and reanalysed by a cardiologist blinded to patient CKD-stage.
Measured: No later than 1 month after central BP measurements
Association of arterial stiffness (defined as Pulse Wave Velocity (PWV)) and aortic calcification
To get a non-invasive estimate of arterial stiffness, measurement of Pulse Wave Velocity (PWV) (carotid-femoral and carotid-radial) will be performed. PWV will be recorded with the Sphygmocor® device according to regular protocol. Calibration of the device will be performed using an oscillometric device after 5 minutes of rest. Only measurements with an estimated standard deviation of +/- 1.0 m/s will be accepted and included in the study. If possible, two acceptable measurements will be conducted for each included patient. Calculation of PWV will be performed automatically by the device using a previously published formula.
Measured: No later than 1 month after Central BP.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start15 Oct 2019
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arterial CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakob Tobias Nyvad, Central Jutland Regional Hospital
- Investigators
- Niels H Buus, MD PhD DMSc, Study chair, Department of Renal diseases, Aarhus University HospitalJakob T Nyvad, M.D., Principal investigator, The Clinic of Hypertension, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114695
- Sponsor's protocol ID
- VEK-nr 66842
- Acronym
- ACCEPT
- Status last verified
- Mar 2022
- First submitted
- 14 Aug 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nyvad J, Christensen KL, Andersen G, Reinhard M, Norgaard BL, Madsen JS, Nielsen S, Thomsen MB, Jensen JM, Peters CD, Buus NH. PIVKA-II but not dp-ucMGP is associated with aortic calcification in chronic kidney disease. BMC Nephrol. 2024 Nov 27;25(1):426. doi: 10.1186/s12882-024-03876-5.
PubMed 39604863Nyvad J, Christensen KL, Andersen G, Reinhard M, Maeng M, Nielsen S, Thomsen MB, Jensen JM, Norgaard BL, Buus NH. Aortic Calcification is Associated With the Difference Between Invasive Central and Cuff-Measured Brachial Blood Pressure in Chronic Kidney Disease. Am J Hypertens. 2024 Jun 14;37(7):455-464. doi: 10.1093/ajh/hpae029.
PubMed 38477704
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Calcification and Central Blood Pressure in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04114695
- Acronym / sponsor ID
- ACCEPT / VEK-nr 66842
- Conditions
- Arterial Calcification, Kidney Diseases, Coronary Artery Disease, Aortic Calcification, Stroke, Vascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim and background:
This study will seek to identify physiological and biochemical factors explaining and predicting a higher than expected central (aortic) blood pressure (BP) in patients with chronic kidney disease (CKD). The basic hypothesis of the study is that the degree of aortic calcification is an important component of elevated central BP, which, in turn, is important for the organ-damage and increased risk of cardiovascular disease associated with CKD.
Methods:
Adult patients with varying degrees of CKD undergoing scheduled coronary angiography (CAG) at Aarhus University Hospital will be included in this study.
During the CAG procedure, systolic and diastolic BP is determined in the ascending part of aorta by a calibrated pressure transducer connected to the fluid-filled CAG catheter.
Simultaneous with the registration of invasive aortic BP, estimation of central BP is performed using radial artery tonometry (SphygmoCor®), while a corresponding brachial BP is also measured.
Prior to the CAG, a non-contrast CT scan of aorta in its entirety will be performed to enable blinded quantification of calcification in the wall of aorta and coronary arteries.
Furthermore, echocardiography, resting BP measurement and a range of blood- and urine samples will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Non-CKD (eGFR >60 ml/min/1.73 m2) | – | –Patients with renal function considered normal for age (eGFR >60 ml/min/1.73 m2) without proteinuria or structural kidney disease. |
| CKD stage 3a (eGFR 45-59 ml/min/1,73 m2) | – | –Patients with CKD stage 3a (eGFR 45-59 ml/min/1,73 m2) |
| CKD stage 3b (eGFR 30-44 ml/min/1,73 m2) | – | –Patients with CKD stage 3b (eGFR 30-44 ml/min/1,73 m2) |
| CKD stage 4 (eGFR 15-29 ml/min/1,73 m2) | – | –Patients with CKD stage 4 (eGFR 15-29 ml/min/1,73 m2) |
| CKD stage 5 (eGFR <15 ml/min/1,73 m2) | – | –Patients with CKD stage 5 (eGFR <15 ml/min/1,73 m2). 50% of these patients will be in dialysis, while the other 50% will be pre-dialysis patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for CAG can be included in the study if they satisfy all inclusion criteria and do not meet any exclusion criteria. The study cohort will consist of: 1. 160 patients with CKD at various stages based on estimated glomerular filtration rate (eGFR): 40 patients in stage 3a (eGFR 45-59 ml/min/1,73 m2), 40 patients in stage 3b (30-44 ml/min/1,73 m2), 40 patients in stage 4 (15-29 ml/min/1,73 m2) and 40 in stage 5 (<15 ml/min/1,73 m2). The stage 5 patients will be distributed between non-dialysis and dialysis patients. 2. 40 patients with renal function considered normal for age (eGFR ≥60 ml/min/1.73 m2) without proteinuria or structural kidney disease.
Key inclusion criteria (4 listed)
- Age >18 years
- Patient referred for planned CAG at the Department of Cardiology, Aarhus University Hospital (AUH)
- eGFR constantly either >60 ml/min or <60 ml/min in at least 2 separate blood-sample measurements over at least 3 months.
- Signed informed consent-form.
Key exclusion criteria (6 listed)
- Antihypertensive treatment changed within the last two weeks prior to the CAG.
- Severe aortic valve stenosis (<1 cm) as central hemodynamics may be altered
- Maximum number of patients in CKD-group already reached.
- Atrial fibrillation or other cardiac arrhythmia making radial Pulse Wave Analysis (PWA) estimations impossible.
- Known significant stenosis of a. subclavia or a. brachialis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The difference between directly measured and estimated aortic (central) systolic blood pressure and the corresponding brachial systolic blood pressure
Time frame: During the CAG-procedure
Systolic arterial pressure will be determined in the ascending part of aorta using a calibrated pressure transducer connected to the CAG catheter. Simultaneous measurement with af Oscillometric BP-device (Microlife A2 Basic) will be conducted. The difference in mmHg will be calculated.
The degree of aortic calcification
Time frame: CT-scan will be performed prior to CAG if logistically possible and no later than 3 weeks after CAG. All Agatston scoring will be completed when all patients have been included in the study during the summer of 2021.
The degree of calcification in the wall of the ascending, arcus, descending and abdominal aorta will be measured with a non-contrast CT scan. Agatston-scoring will be applied on the CT images 2 cm after the aortic valve to the aortic bifurcation to ensure that aortic valve calcification is not included in the score. All Agatston scoring will be performed by a radiologist blinded to information on patient biochemical characteristics.
The difference between directly measured and estimated aortic (central) diastolic blood pressure and the corresponding brachial diastolic blood pressure.
Time frame: During the CAG procedure
Diastolic arterial pressure will be determined in the ascending part of aorta using a calibrated pressure transducer connected to the CAG catheter. Simultaneous measurement with af Oscillometric BP-device (Microlife A2 Basic) will be conducted. The difference in mmHg will be calculated.
27 secondary outcomes
Association between Matrix Gla Protein (MGP) and aortic calcification
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between Calcification propensity score (T50test) and aortic calcification
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between sRANKL (soluble receptor activator of nuclear factor kappa-B ligand) and aortic calcification
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between 25-OH-Vitamin D(D3+D2) and aortic calcification
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between Fetuin-A(alfa-2-Heremans Schmid glycoprotein; AHSG) and aortic calcification
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021.
Association between Sclerostin and aortic calcification
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between osteoprotegerin and aortic calcification
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between BsAP (bone-specific alkaline phosphatase) and aortic calcification
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between TRAP5B (tartrate-resistant acid phosphatase 5b) and aortic calcification
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between P1NP (procollagen type 1 N propeptide) and aortic calcification
Time frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between aortic calcification and Left Ventricular Global Longitudinal Strain (GLS) as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association between aortic calcification and LVDd (Left ventricular diameter in diastole) as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association between aortic calcification and IVS (Interventricular septum thickness) as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association between aortic calcification and Two-dimensional automated evaluation of ejection fraction (2-D auto-EF) as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association between aortic calcification and Aorta (sinus) diameter as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association between aortic calcification and Early mitral inflow velocity (E) as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association between aortic calcification and Duration of Pulmonal Vein Reversal as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association between aortic calcification and Late mitral inflow velocity (A) as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association between aortic calcification and Early diastolic mitral annulus velocity (E') as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association between aortic calcification and PW (Posterior wall thickness) as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association between aortic calcification and Aorta (ascendens) diameter as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association between aortic calcification and RVDd (Right ventricular diameter in diastole) as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association between aortic calcification and LAD (Left atrial diameter) as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association between aortic calcification and LAV (Left atrial volume) as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association between aortic calcification and TEI-Index as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association between aortic calcification and Tricuspid annular plane systolic excursion (TAPSE) as determined during echocardiography.
Time frame: No later than 1 month after central BP measurements
Association of arterial stiffness (defined as Pulse Wave Velocity (PWV)) and aortic calcification
Time frame: No later than 1 month after Central BP.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 39604863Nyvad J, Christensen KL, Andersen G, Reinhard M, Norgaard BL, Madsen JS, Nielsen S, Thomsen MB, Jensen JM, Peters CD, Buus NH. PIVKA-II but not dp-ucMGP is associated with aortic calcification in chronic kidney disease. BMC Nephrol. 2024 Nov 27;25(1):426. doi: 10.1186/s12882-024-03876-5.
- Derived from this study: PubMed 38477704Nyvad J, Christensen KL, Andersen G, Reinhard M, Maeng M, Nielsen S, Thomsen MB, Jensen JM, Norgaard BL, Buus NH. Aortic Calcification is Associated With the Difference Between Invasive Central and Cuff-Measured Brachial Blood Pressure in Chronic Kidney Disease. Am J Hypertens. 2024 Jun 14;37(7):455-464. doi: 10.1093/ajh/hpae029.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels H Buus, MD PhD DMSc study chair
Department of Renal diseases, Aarhus University Hospital
Jakob T Nyvad, M.D. principal investigator
The Clinic of Hypertension, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Calcification and Kidney Diseases, run by Central Jutland Regional Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between directly measured and estimated aortic (central) systolic blood pressure and the corresponding brachial systolic blood pressure (time frame: During the CAG-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04114695, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.