Arterial HypertensionNCT03094702
SPRINT Trial Type Blood Pressure Measurements in Patients After Kidney Transplantation
An observational study of Arterial Hypertension and Kidney Transplant; Complications, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
The SPRINT study used a blood pressure measurement procedure that differs from earlier studies in arterial hypertension. SPRINT type readings are lower than regular office measurements. The extent of the disagreement between SPRINT and office measurements may differ in distinct patient groups. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Arterial Hypertension, Kidney Transplant; Complications
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2017to 1 Apr 2017
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Patients (m/f) with a functional renal transplant who are not dependent on dialysis treatment * Age 18 - 99 years * Riva-Rocchi blood pressure measurement at least at one arm possible * Informed consent
Who may be able to join
- Patients (m/f) with a functional renal transplant who are not dependent on dialysis treatment
- Age 18 - 99 years
- Riva-Rocchi blood pressure measurement at least at one arm possible
- Informed consent
Who cannot join
- No consent with study participation
- Psychiatric disorders preventing from valid informed consent
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Internal Medicine II, Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony-Anhalt, 06120
About this study
Official title: Influence of SPRINT Trial Type Blood Pressure Measurements on Hypertension Diagnosis in Patients After Kidney Transplantation
The SPRINT study used a blood pressure measurement procedure that differs from earlier studies in arterial hypertension. SPRINT type readings are lower than regular office measurements. The extent of the disagreement between SPRINT and office measurements may differ in distinct patient groups. This difference is not yet known for patients after renal transplantation. However, it is important to know the difference in order to apply SPRINT findings to transplant recipients.
Read the detailed description
Most clinical trials on the treatment of arterial hypertension use office blood pressure measurements (Franklin et al. 2001; Hansson et al. 1998) both as inclusion criteria and study end-points. In these trials, blood pressure is taken by manual or automated devices in outpatients coming to a study center, as recommended by the European Society of Cardiology/European Society of Hypertension (ESC/ESH) Guidelines for the management of arterial hypertension (Mancia et al. 2013). The target blood pressure as recommended by European (Mancia et al. 2013) or US (James et al. 2014) guidelines largely depends on the results of the Hypertension Optimal Treatment (HOT) study (Hansson et al. 1998). This large trial with >18.000 participants measured blood pressure with an oscillometric device three times in a row in seated patients after 5min of rest. This and similar trials form the backbone of our knowledge about what is considered normal blood pressure and what blood pressure levels should be aimed at when using antihypertensive treatment (Zanchetti et al. 2009).
Studies using 24h-blood pressure measurement devices indicated that the normal values are lower (average 10/5mmHg) with this technique than with regular office measurements (Head et al. 2010). It is well known that there is a so called "white coat" hypertension, i.e. higher blood pressure values are taken in the doctor's office than at home (Mancia et al. 1987). The amount of this white-coat effect is largely different between individuals. Although white-coat hypertension itself has some prognostic impact on the patient (Verdecchia et al. 2005) it is much less relevant than overt hypertension. It seems reasonable to keep the White coat effect in mind to avoid over-therapy in patients in whom this effect is particularly strong.
While the framework for clinical decision making is mostly based on studies using office blood pressure readings, the SPRINT study (Wright et al. 2015) recently used another way of measuring blood pressure. The SPRINT study included more than 9.300 cardiovascular high-risk individuals without diabetes mellitus. It was a randomized prospective trial with intervention aiming at a low (<120 mmHg) vs. standard (<140 mmHg) systolic blood pressure. The trial was stopped early because of the large benefit of the intervention on the combined cardiovascular end-point. Since publication of this study, there is a vivid scientific discussion whether the low blood pressure goal should be aimed at in different patient populations.
The SPRINT study used a unique way of determining blood pressure. Patients were left alone in a quiet room with a programmed blood-pressure reading device that took readings at intervals after 5 minutes of relaxing. Recent studies showed that the blood pressure readings taken with the SPRINT technique are relevantly lower than the readings with regular office blood pressure measurements (Wohlfahrt et al. 2016).
Patients after renal transplantation very frequently have arterial hypertension (Kasiske et al. 2004; Paoletti et al. 2009). This is in part induced by the kidney disease or effects of the transplant and the immunosuppressive therapy; thus it might be considered a form of secondary hypertension. The KDIGO guideline (KDIGO clinical practice guideline for the care of kidney transplant recipients 2009) recommends to maintain blood pressure <130/80 mmHg in these patients. This recommendation is based on analogy to data from the general population and has not been formally proven in transplant patients. In order to determine if the SPRINT results can be extrapolated to transplant recipients as well, it is important to show the effect size of the different blood pressure measurement techniques (SPRINT vs. regular office BP) in this particular patient group.
The study intends to quantify the difference in blood pressure when read by regular ("real life") measurement or by the SPRINT procedure (primary goal).
In addition the study will describe factors that influence this difference (e.g. renal function, proteinuria, age, time since transplantation...) (secondary goals).
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between Office Blood Pressure and SPRINT type BP
Manual Office blood pressure [mmHg] minus Automated Office blood pressure [mmHg]
Measured: Single Measurement at inclusion (day 1)
Secondary outcomes (3)
Renal Function
Estimated Glomerular Filtration Rate (eGFR) [ml/min]
Measured: Single Measurement at inclusion (day 1)
Proteinuria
Albumin-Creatinine-Ratio [g/g] or Protein concentration in 24h collected Urine [mmol/l]
Measured: Single Measurement at inclusion (day 1)
Immunosuppressant use
Dose of Immunosuppression given as ddd [daily defined doses]
Measured: Data acquisition at inclusion (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 Jan 2017
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Arterial HypertensionStudies 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
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Matthias Girndt, Prof. Dr., Study chair, Department of Internal Medicine II, Martin-Luther-Universität Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094702
- Sponsor's protocol ID
- UKH-KIMII-001-17
- Status last verified
- Oct 2017
- First submitted
- 9 Mar 2017
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Franklin SS, Larson MG, Khan SA, Wong ND, Leip EP, Kannel WB, Levy D. Does the relation of blood pressure to coronary heart disease risk change with aging? The Framingham Heart Study. Circulation. 2001 Mar 6;103(9):1245-9. doi: 10.1161/01.cir.103.9.1245.
PubMed 11238268Hansson L, Zanchetti A, Carruthers SG, Dahlof B, Elmfeldt D, Julius S, Menard J, Rahn KH, Wedel H, Westerling S. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group. Lancet. 1998 Jun 13;351(9118):1755-62. doi: 10.1016/s0140-6736(98)04311-6.
PubMed 9635947Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.
PubMed 23817082James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427.
PubMed 24352797Zanchetti A, Grassi G, Mancia G. When should antihypertensive drug treatment be initiated and to what levels should systolic blood pressure be lowered? A critical reappraisal. J Hypertens. 2009 May;27(5):923-34. doi: 10.1097/HJH.0b013e32832aa6b5.
PubMed 19381107Head GA, Mihailidou AS, Duggan KA, Beilin LJ, Berry N, Brown MA, Bune AJ, Cowley D, Chalmers JP, Howe PR, Hodgson J, Ludbrook J, Mangoni AA, McGrath BP, Nelson MR, Sharman JE, Stowasser M; Ambulatory Blood Pressure Working Group of the High Blood Pressure Research Council of Australia. Definition of ambulatory blood pressure targets for diagnosis and treatment of hypertension in relation to clinic blood pressure: prospective cohort study. BMJ. 2010 Apr 14;340:c1104. doi: 10.1136/bmj.c1104.
PubMed 20392760Mancia G, Parati G, Pomidossi G, Grassi G, Casadei R, Zanchetti A. Alerting reaction and rise in blood pressure during measurement by physician and nurse. Hypertension. 1987 Feb;9(2):209-15. doi: 10.1161/01.hyp.9.2.209.
PubMed 3818018Verdecchia P, Reboldi GP, Angeli F, Schillaci G, Schwartz JE, Pickering TG, Imai Y, Ohkubo T, Kario K. Short- and long-term incidence of stroke in white-coat hypertension. Hypertension. 2005 Feb;45(2):203-8. doi: 10.1161/01.HYP.0000151623.49780.89. Epub 2004 Dec 13.
PubMed 15596572SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9.
PubMed 26551272Wohlfahrt P, Cifkova R, Movsisyan N, Kunzova S, Lesovsky J, Homolka M, Soska V, Bauerova H, Lopez-Jimenez F, Sochor O. Threshold for diagnosing hypertension by automated office blood pressure using random sample population data. J Hypertens. 2016 Nov;34(11):2180-6. doi: 10.1097/HJH.0000000000001076.
PubMed 27512968Kasiske BL, Anjum S, Shah R, Skogen J, Kandaswamy C, Danielson B, O'Shaughnessy EA, Dahl DC, Silkensen JR, Sahadevan M, Snyder JJ. Hypertension after kidney transplantation. Am J Kidney Dis. 2004 Jun;43(6):1071-81. doi: 10.1053/j.ajkd.2004.03.013.
PubMed 15168388Paoletti E, Gherzi M, Amidone M, Massarino F, Cannella G. Association of arterial hypertension with renal target organ damage in kidney transplant recipients: the predictive role of ambulatory blood pressure monitoring. Transplantation. 2009 Jun 27;87(12):1864-9. doi: 10.1097/TP.0b013e3181a76775.
PubMed 19543066Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009 Nov;9 Suppl 3:S1-155. doi: 10.1111/j.1600-6143.2009.02834.x.
PubMed 19845597
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of SPRINT Trial Type Blood Pressure Measurements on Hypertension Diagnosis in Patients After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT03094702
- Acronym / sponsor ID
- UKH-KIMII-001-17
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 29 Mar 2017 (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.
The SPRINT study used a blood pressure measurement procedure that differs from earlier studies in arterial hypertension. SPRINT type readings are lower than regular office measurements. The extent of the disagreement between SPRINT and office measurements may differ in distinct patient groups. This difference is not yet known for patients after renal transplantation. However, it is important to know the difference in order to apply SPRINT findings to transplant recipients.
Detailed description
Most clinical trials on the treatment of arterial hypertension use office blood pressure measurements (Franklin et al. 2001; Hansson et al. 1998) both as inclusion criteria and study end-points. In these trials, blood pressure is taken by manual or automated devices in outpatients coming to a study center, as recommended by the European Society of Cardiology/European Society of Hypertension (ESC/ESH) Guidelines for the management of arterial hypertension (Mancia et al. 2013). The target blood pressure as recommended by European (Mancia et al. 2013) or US (James et al. 2014) guidelines largely depends on the results of the Hypertension Optimal Treatment (HOT) study (Hansson et al. 1998). This large trial with >18.000 participants measured blood pressure with an oscillometric device three times in a row in seated patients after 5min of rest. This and similar trials form the backbone of our knowledge about what is considered normal blood pressure and what blood pressure levels should be aimed at when using antihypertensive treatment (Zanchetti et al. 2009).
Studies using 24h-blood pressure measurement devices indicated that the normal values are lower (average 10/5mmHg) with this technique than with regular office measurements (Head et al. 2010). It is well known that there is a so called "white coat" hypertension, i.e. higher blood pressure values are taken in the doctor's office than at home (Mancia et al. 1987). The amount of this white-coat effect is largely different between individuals. Although white-coat hypertension itself has some prognostic impact on the patient (Verdecchia et al. 2005) it is much less relevant than overt hypertension. It seems reasonable to keep the White coat effect in mind to avoid over-therapy in patients in whom this effect is particularly strong.
While the framework for clinical decision making is mostly based on studies using office blood pressure readings, the SPRINT study (Wright et al. 2015) recently used another way of measuring blood pressure. The SPRINT study included more than 9.300 cardiovascular high-risk individuals without diabetes mellitus. It was a randomized prospective trial with intervention aiming at a low (<120 mmHg) vs. standard (<140 mmHg) systolic blood pressure. The trial was stopped early because of the large benefit of the intervention on the combined cardiovascular end-point. Since publication of this study, there is a vivid scientific discussion whether the low blood pressure goal should be aimed at in different patient populations.
The SPRINT study used a unique way of determining blood pressure. Patients were left alone in a quiet room with a programmed blood-pressure reading device that took readings at intervals after 5 minutes of relaxing. Recent studies showed that the blood pressure readings taken with the SPRINT technique are relevantly lower than the readings with regular office blood pressure measurements (Wohlfahrt et al. 2016).
Patients after renal transplantation very frequently have arterial hypertension (Kasiske et al. 2004; Paoletti et al. 2009). This is in part induced by the kidney disease or effects of the transplant and the immunosuppressive therapy; thus it might be considered a form of secondary hypertension. The KDIGO guideline (KDIGO clinical practice guideline for the care of kidney transplant recipients 2009) recommends to maintain blood pressure <130/80 mmHg in these patients. This recommendation is based on analogy to data from the general population and has not been formally proven in transplant patients. In order to determine if the SPRINT results can be extrapolated to transplant recipients as well, it is important to show the effect size of the different blood pressure measurement techniques (SPRINT vs. regular office BP) in this particular patient group.
The study intends to quantify the difference in blood pressure when read by regular ("real life") measurement or by the SPRINT procedure (primary goal).
In addition the study will describe factors that influence this difference (e.g. renal function, proteinuria, age, time since transplantation...) (secondary goals).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients (m/f) with a functional renal transplant who are not dependent on dialysis treatment * Age 18 - 99 years * Riva-Rocchi blood pressure measurement at least at one arm possible * Informed consent
Key inclusion criteria (4 listed)
- Patients (m/f) with a functional renal transplant who are not dependent on dialysis treatment
- Age 18 - 99 years
- Riva-Rocchi blood pressure measurement at least at one arm possible
- Informed consent
Key exclusion criteria (3 listed)
- No consent with study participation
- Psychiatric disorders preventing from valid informed consent
- Pregnancy or lactation
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
Difference between Office Blood Pressure and SPRINT type BP
Time frame: Single Measurement at inclusion (day 1)
Manual Office blood pressure [mmHg] minus Automated Office blood pressure [mmHg]
3 secondary outcomes
Renal Function
Time frame: Single Measurement at inclusion (day 1)
Proteinuria
Time frame: Single Measurement at inclusion (day 1)
Immunosuppressant use
Time frame: Data acquisition at inclusion (day 1)
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 27 Oct 2017.
- Background: PubMed 11238268Franklin SS, Larson MG, Khan SA, Wong ND, Leip EP, Kannel WB, Levy D. Does the relation of blood pressure to coronary heart disease risk change with aging? The Framingham Heart Study. Circulation. 2001 Mar 6;103(9):1245-9. doi: 10.1161/01.cir.103.9.1245.
- Background: PubMed 9635947Hansson L, Zanchetti A, Carruthers SG, Dahlof B, Elmfeldt D, Julius S, Menard J, Rahn KH, Wedel H, Westerling S. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group. Lancet. 1998 Jun 13;351(9118):1755-62. doi: 10.1016/s0140-6736(98)04311-6.
- Background: PubMed 23817082Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.
- Background: PubMed 24352797James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427.
- Background: PubMed 19381107Zanchetti A, Grassi G, Mancia G. When should antihypertensive drug treatment be initiated and to what levels should systolic blood pressure be lowered? A critical reappraisal. J Hypertens. 2009 May;27(5):923-34. doi: 10.1097/HJH.0b013e32832aa6b5.
- Background: PubMed 20392760Head GA, Mihailidou AS, Duggan KA, Beilin LJ, Berry N, Brown MA, Bune AJ, Cowley D, Chalmers JP, Howe PR, Hodgson J, Ludbrook J, Mangoni AA, McGrath BP, Nelson MR, Sharman JE, Stowasser M; Ambulatory Blood Pressure Working Group of the High Blood Pressure Research Council of Australia. Definition of ambulatory blood pressure targets for diagnosis and treatment of hypertension in relation to clinic blood pressure: prospective cohort study. BMJ. 2010 Apr 14;340:c1104. doi: 10.1136/bmj.c1104.
- Background: PubMed 3818018Mancia G, Parati G, Pomidossi G, Grassi G, Casadei R, Zanchetti A. Alerting reaction and rise in blood pressure during measurement by physician and nurse. Hypertension. 1987 Feb;9(2):209-15. doi: 10.1161/01.hyp.9.2.209.
- Background: PubMed 15596572Verdecchia P, Reboldi GP, Angeli F, Schillaci G, Schwartz JE, Pickering TG, Imai Y, Ohkubo T, Kario K. Short- and long-term incidence of stroke in white-coat hypertension. Hypertension. 2005 Feb;45(2):203-8. doi: 10.1161/01.HYP.0000151623.49780.89. Epub 2004 Dec 13.
- Background: PubMed 26551272SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9.
- Background: PubMed 27512968Wohlfahrt P, Cifkova R, Movsisyan N, Kunzova S, Lesovsky J, Homolka M, Soska V, Bauerova H, Lopez-Jimenez F, Sochor O. Threshold for diagnosing hypertension by automated office blood pressure using random sample population data. J Hypertens. 2016 Nov;34(11):2180-6. doi: 10.1097/HJH.0000000000001076.
- Background: PubMed 15168388Kasiske BL, Anjum S, Shah R, Skogen J, Kandaswamy C, Danielson B, O'Shaughnessy EA, Dahl DC, Silkensen JR, Sahadevan M, Snyder JJ. Hypertension after kidney transplantation. Am J Kidney Dis. 2004 Jun;43(6):1071-81. doi: 10.1053/j.ajkd.2004.03.013.
- Background: PubMed 19543066Paoletti E, Gherzi M, Amidone M, Massarino F, Cannella G. Association of arterial hypertension with renal target organ damage in kidney transplant recipients: the predictive role of ambulatory blood pressure monitoring. Transplantation. 2009 Jun 27;87(12):1864-9. doi: 10.1097/TP.0b013e3181a76775.
- Individual participant dataSharing planned: Undecided
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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.
Matthias Girndt, Prof. Dr. study chair
Department of Internal Medicine II, Martin-Luther-Universität Halle-Wittenberg
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 Hypertension and Kidney Transplant; Complications, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
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 3 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 27 Oct 2017. 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 Germany. 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?
Difference between Office Blood Pressure and SPRINT type BP (time frame: Single Measurement at inclusion (day 1)). 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 NCT03094702, which also lists 13 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 27 Oct 2017.