Blood Pressure ControlNCT01093703

Chronotherapy Versus Conventional BP Control to Correct Abnormal Circadian BP Pattern in Kidney Transplant Recipients

A study testing Medication Adjustment in people with Blood Pressure Control and Kidney Transplant Recipient, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Blood Pressure Control, Kidney Transplant Recipient
What is being tested?: Medication Adjustment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 99 participants
Where: 1 siteUnited States
Study dates: Dec 2008to Nov 2012
Phase: Interventional
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

Who may be able to join

Recipient of a kidney transplant.
Age≥18 years.
Stable allograft function.
Ability to give informed consent.

Who cannot join

Multiorgan transplant recipients.
Kidney transplant recipients with poor allograft function.
Documented history of obstructive sleep apnea.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Jacksonville, Florida, 32224

Other trials in United States

About this study

Official title: Randomized Trial to Explore the Effect of Chronotherapy Versus Conventional BP Control to Correct Abnormal Circadian BP Pattern and Improve Allograft Function in Kidney Transplant Recipients

The purpose of this study is to identify and manage factors related to blood pressure control that impact organ function and survival in kidney transplant recipients. Loss of the circadian (relating to a 24-hour rhythm) blood pressure pattern is common in kidney transplant recipients and is associated with poor allograft kidney function. It is still unclear if restoring the normal day-night blood pressure (BP) pattern will translate into better allograft outcome. Although studies in patients with and without chronic kidney disease indicate that restoration of the normal nocturnal (night) dipping in BP is possible by changing the timing of the BP medications to cover the overnight period (chronotherapy), this has not been tested in kidney transplant patients.

Read the detailed description

The challenge in kidney transplantation is to identify and manage factors that impact allograft function and survival. Loss of the circadian blood pressure pattern is common in kidney transplant recipients and is associated with poor allograft kidney function. Nevertheless, it is unclear if restoring the normal day-night BP pattern will translate into better allograft outcome. Although studies in patients with and without chronic kidney disease indicate that restoration of the normal nocturnal dipping in BP is possible by changing the timing of the BP medications to cover the overnight period (chronotherapy), this has not been tested in kidney transplant patients. This exploratory study is driven by the hypothesis that chronotherapy will restore the normal circadian BP pattern and will translate into better allograft function and into lower LVM 1-year from transplantation.

Conditions: Blood Pressure Control, Kidney Transplant Recipient
Being tested: Medication Adjustment
Keywords: kidney transplantation, hypertension, chronotherapy, graft function, circadian pattern
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medication AdjustmentOther
1. Awake SBP≤135/85mmHg and patient is on once daily medications: Switch BP medications to pm period.
2. Awake SBP SBP≤135/85mmHg and patient is on bid medications (e.g. metoprolol bid): Increase pm dose of the medication. If medication is already is at maximal dose or there is contraindication for increasing the dose (e.g. bradycardia), add another BP medicine in the evening time.
3. Awake SBP≤135/85mmHg and patient is not on anti-hypertensive medications: Add BP medication at the pm period.
4. Awake SBP>135/85mmHg: increase dose of antihypertensive medications or add more medications. All medications to be given in the evening time.

Study groups in NCT01093703
Study group	Role	What they receive
Conventional Therapy	No intervention	In the conventional therapy group, no medication changes other than the ones needed to achieve target awake average SBP will be undertaken. Time at which patients are taking their BP medications will be recorded.
Intensive Therapy	Active comparator	In the intensive therapy group, BP medications will be adjusted to both control awake average systolic BP to target and to cover the overnight period in an attempt to control nocturnal hypertension. Receives: Other: Medication Adjustment

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent drop in mean SBP at night-time compared to mean SBP in day-time
Measured: 1 year
Glomerular filtration rate
Measured: 1 year

Secondary outcomes (6)

Awake mean SBP
Measured: 1 year
Presence of abnormal circadian BP pattern in recipients on steroid free and CIN free IS
Measured: 1 year
Change in LVM
Measured: 1 year
Urinary microalbumin excretion
Measured: 4 months & 1 year
Long term renal function
Measured: 2 years
Cardiovascular events (stroke, heart failure, myocardial infarction)
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Nov 2012

First posted26 Mar 2010 (estimated)
Study startDec 2008
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Blood Pressure ControlStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01093703
Sponsor's protocol ID: 08-005049
Status last verified: May 2013
First submitted: 24 Mar 2010
Last updated: 30 May 2013
Results posted: No
Data monitoring committee: Yes

Publications

Mange KC, Cizman B, Joffe M, Feldman HI. Arterial hypertension and renal allograft survival. JAMA. 2000 Feb 2;283(5):633-8. doi: 10.1001/jama.283.5.633.
PubMed 10665703
Kasiske 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 15168388
Opelz G, Dohler B; Collaborative Transplant Study. Improved long-term outcomes after renal transplantation associated with blood pressure control. Am J Transplant. 2005 Nov;5(11):2725-31. doi: 10.1111/j.1600-6143.2005.01093.x.
PubMed 16212633
Clement DL, De Buyzere ML, De Bacquer DA, de Leeuw PW, Duprez DA, Fagard RH, Gheeraert PJ, Missault LH, Braun JJ, Six RO, Van Der Niepen P, O'Brien E; Office versus Ambulatory Pressure Study Investigators. Prognostic value of ambulatory blood-pressure recordings in patients with treated hypertension. N Engl J Med. 2003 Jun 12;348(24):2407-15. doi: 10.1056/NEJMoa022273.
PubMed 12802026
Shimada K, Kawamoto A, Matsubayashi K, Nishinaga M, Kimura S, Ozawa T. Diurnal blood pressure variations and silent cerebrovascular damage in elderly patients with hypertension. J Hypertens. 1992 Aug;10(8):875-8.
PubMed 1325522
Verdecchia P, Porcellati C, Schillaci G, Borgioni C, Ciucci A, Battistelli M, Guerrieri M, Gatteschi C, Zampi I, Santucci A, Santucci C, Reboldi G, et al. Ambulatory blood pressure. An independent predictor of prognosis in essential hypertension. Hypertension. 1994 Dec;24(6):793-801. doi: 10.1161/01.hyp.24.6.793.
PubMed 7995639
Haydar AA, Covic A, Jayawardene S, Agharazii M, Smith E, Gordon I, O'Sullivan H, Goldsmith DJ. Insights from ambulatory blood pressure monitoring: diagnosis of hypertension and diurnal blood pressure in renal transplant recipients. Transplantation. 2004 Mar 27;77(6):849-53. doi: 10.1097/01.tp.0000115345.16853.51.
PubMed 15077025
Agarwal R, Andersen MJ. Prognostic importance of ambulatory blood pressure recordings in patients with chronic kidney disease. Kidney Int. 2006 Apr;69(7):1175-80. doi: 10.1038/sj.ki.5000247.
PubMed 16467785
Lurbe E, Redon J, Kesani A, Pascual JM, Tacons J, Alvarez V, Batlle D. Increase in nocturnal blood pressure and progression to microalbuminuria in type 1 diabetes. N Engl J Med. 2002 Sep 12;347(11):797-805. doi: 10.1056/NEJMoa013410.
PubMed 12226150
Davidson MB, Hix JK, Vidt DG, Brotman DJ. Association of impaired diurnal blood pressure variation with a subsequent decline in glomerular filtration rate. Arch Intern Med. 2006 Apr 24;166(8):846-52. doi: 10.1001/archinte.166.8.846.
PubMed 16636209
Kapa S, Sert Kuniyoshi FH, Somers VK. Sleep apnea and hypertension: interactions and implications for management. Hypertension. 2008 Mar;51(3):605-8. doi: 10.1161/HYPERTENSIONAHA.106.076190. Epub 2008 Jan 28. No abstract available.
PubMed 18227409
Pennestri MH, Montplaisir J, Colombo R, Lavigne G, Lanfranchi PA. Nocturnal blood pressure changes in patients with restless legs syndrome. Neurology. 2007 Apr 10;68(15):1213-8. doi: 10.1212/01.wnl.0000259036.89411.52.
PubMed 17420405
Khot UN, Binkley PF, Haas GJ, Starling RC. Prospective study of the circadian pattern of blood pressure after heart transplantation. J Heart Lung Transplant. 1996 Apr;15(4):350-9.
PubMed 8732593
Taler SJ, Textor SC, Canzanello VJ, Wilson DJ, Wiesner RH, Krom RA. Loss of nocturnal blood pressure fall after liver transplantation during immunosuppressive therapy. Am J Hypertens. 1995 Jun;8(6):598-605. doi: 10.1016/0895-7061(95)00077-3.
PubMed 7544983
Toprak A, Koc M, Tezcan H, Ozener IC, Oktay A, Akoglu E. Night-time blood pressure load is associated with higher left ventricular mass index in renal transplant recipients. J Hum Hypertens. 2003 Apr;17(4):239-44. doi: 10.1038/sj.jhh.1001536.
PubMed 12692568

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Not yet recruiting
Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy
Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced
Recruiting
Smartwatch-based Intervention for Cardiovascular Health (SWITCH)
Overweight , Obesity, Prediabetes
Recruiting
The Effect of Web-Based Simulation and Flipped Learning on Blood Pressure Education
Education, Education Nursing
Not yet recruiting
Effect of the CALAJECT System on Pain Perception, Heart Rate, and Blood Pressure During Inferior Alveolar Nerve Block: A Randomized Controlled Clinical Trial
Local Anesthesia in Dentistry

All Blood Pressure Control trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial to Explore the Effect of Chronotherapy Versus Conventional BP Control to Correct Abnormal Circadian BP Pattern and Improve Allograft Function in Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT01093703
Acronym / sponsor ID: 08-005049
Conditions: Blood Pressure Control, Kidney Transplant Recipient
Keywords: kidney transplantation, hypertension, chronotherapy, graft function, circadian pattern
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: Dec 2008
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 26 Mar 2010 (estimated)
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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Conventional Therapy	No intervention	–In the conventional therapy group, no medication changes other than the ones needed to achieve target awake average SBP will be undertaken. Time at which patients are taking their BP medications will be recorded.
Intensive Therapy	Active comparator	Other: Medication AdjustmentIn the intensive therapy group, BP medications will be adjusted to both control awake average systolic BP to target and to cover the overnight period in an attempt to control nocturnal hypertension.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Recipient of a kidney transplant.
Age≥18 years.
Stable allograft function.
Ability to give informed consent.

Key exclusion criteria (3 listed)

Multiorgan transplant recipients.
Kidney transplant recipients with poor allograft function.
Documented history of obstructive sleep apnea.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medication Adjustment1. Awake SBP≤135/85mmHg and patient is on once daily medications: Switch BP medications to pm period. 2. Awake SBP SBP≤135/85mmHg and patient is on bid medications (e.g. metoprolol bid): Increase pm dose of the medication. If medication is already is at maximal dose or there is contraindication for increasing the dose (e.g. bradycardia), add another BP medicine in the evening time. 3. Awake SBP≤135/85mmHg and patient is not on anti-hypertensive medications: Add BP medication at the pm period. 4. Awake SBP>135/85mmHg: increase dose of antihypertensive medications or add more medications. All medications to be given in the evening time.	Other	Intensive Therapy

Primary outcome

Percent drop in mean SBP at night-time compared to mean SBP in day-time
Time frame: 1 year
Glomerular filtration rate
Time frame: 1 year

6 secondary outcomes

Awake mean SBP
Time frame: 1 year
Presence of abnormal circadian BP pattern in recipients on steroid free and CIN free IS
Time frame: 1 year
Change in LVM
Time frame: 1 year
Urinary microalbumin excretion
Time frame: 4 months & 1 year
Long term renal function
Time frame: 2 years
Cardiovascular events (stroke, heart failure, myocardial infarction)
Time frame: 2 years

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 30 May 2013.
Background: PubMed 10665703Mange KC, Cizman B, Joffe M, Feldman HI. Arterial hypertension and renal allograft survival. JAMA. 2000 Feb 2;283(5):633-8. doi: 10.1001/jama.283.5.633.
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 16212633Opelz G, Dohler B; Collaborative Transplant Study. Improved long-term outcomes after renal transplantation associated with blood pressure control. Am J Transplant. 2005 Nov;5(11):2725-31. doi: 10.1111/j.1600-6143.2005.01093.x.
Background: PubMed 12802026Clement DL, De Buyzere ML, De Bacquer DA, de Leeuw PW, Duprez DA, Fagard RH, Gheeraert PJ, Missault LH, Braun JJ, Six RO, Van Der Niepen P, O'Brien E; Office versus Ambulatory Pressure Study Investigators. Prognostic value of ambulatory blood-pressure recordings in patients with treated hypertension. N Engl J Med. 2003 Jun 12;348(24):2407-15. doi: 10.1056/NEJMoa022273.
Background: PubMed 1325522Shimada K, Kawamoto A, Matsubayashi K, Nishinaga M, Kimura S, Ozawa T. Diurnal blood pressure variations and silent cerebrovascular damage in elderly patients with hypertension. J Hypertens. 1992 Aug;10(8):875-8.
Background: PubMed 7995639Verdecchia P, Porcellati C, Schillaci G, Borgioni C, Ciucci A, Battistelli M, Guerrieri M, Gatteschi C, Zampi I, Santucci A, Santucci C, Reboldi G, et al. Ambulatory blood pressure. An independent predictor of prognosis in essential hypertension. Hypertension. 1994 Dec;24(6):793-801. doi: 10.1161/01.hyp.24.6.793.
Background: PubMed 15077025Haydar AA, Covic A, Jayawardene S, Agharazii M, Smith E, Gordon I, O'Sullivan H, Goldsmith DJ. Insights from ambulatory blood pressure monitoring: diagnosis of hypertension and diurnal blood pressure in renal transplant recipients. Transplantation. 2004 Mar 27;77(6):849-53. doi: 10.1097/01.tp.0000115345.16853.51.
Background: PubMed 16467785Agarwal R, Andersen MJ. Prognostic importance of ambulatory blood pressure recordings in patients with chronic kidney disease. Kidney Int. 2006 Apr;69(7):1175-80. doi: 10.1038/sj.ki.5000247.
Background: PubMed 12226150Lurbe E, Redon J, Kesani A, Pascual JM, Tacons J, Alvarez V, Batlle D. Increase in nocturnal blood pressure and progression to microalbuminuria in type 1 diabetes. N Engl J Med. 2002 Sep 12;347(11):797-805. doi: 10.1056/NEJMoa013410.
Background: PubMed 16636209Davidson MB, Hix JK, Vidt DG, Brotman DJ. Association of impaired diurnal blood pressure variation with a subsequent decline in glomerular filtration rate. Arch Intern Med. 2006 Apr 24;166(8):846-52. doi: 10.1001/archinte.166.8.846.
Background: PubMed 18227409Kapa S, Sert Kuniyoshi FH, Somers VK. Sleep apnea and hypertension: interactions and implications for management. Hypertension. 2008 Mar;51(3):605-8. doi: 10.1161/HYPERTENSIONAHA.106.076190. Epub 2008 Jan 28. No abstract available.
Background: PubMed 17420405Pennestri MH, Montplaisir J, Colombo R, Lavigne G, Lanfranchi PA. Nocturnal blood pressure changes in patients with restless legs syndrome. Neurology. 2007 Apr 10;68(15):1213-8. doi: 10.1212/01.wnl.0000259036.89411.52.

Related trials for Blood Pressure Control

Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Not yet recruiting
Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy
Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced
Recruiting
Smartwatch-based Intervention for Cardiovascular Health (SWITCH)
Overweight , Obesity, Prediabetes
Recruiting
The Effect of Web-Based Simulation and Flipped Learning on Blood Pressure Education
Education, Education Nursing
Not yet recruiting
Effect of the CALAJECT System on Pain Perception, Heart Rate, and Blood Pressure During Inferior Alveolar Nerve Block: A Randomized Controlled Clinical Trial
Local Anesthesia in Dentistry

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Medication Adjustment in people with Blood Pressure Control and Kidney Transplant Recipient, run by Mayo Clinic at 1 site in United States.

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 30 May 2013. 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 United States. 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?

Percent drop in mean SBP at night-time compared to mean SBP in day-time (time frame: 1 year). The study lists 2 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 NCT01093703, which also lists 24 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 30 May 2013.