Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study
NCT ID: NCT01120613
Last Updated: 2013-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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chronotherapy
Patients identified with Nocturnal Hypertension, will have one of the blood pressure medications switched from daytime dosing to nighttime dosing
Chronotherapy
Patients identified with nocturnal hypertension while treated with blood pressure medications will have one medication switched from daytime to night time dosing in the following preference:
1. ACE or ARB
2. Calcium Channel Blockers
3. Alpha Blocker
4. Beta Blocker
If patient is on only one daytime BP medication, it will be switched to night time dosing. No dose adjustments will be made nor any new medications will be added. Only timing of BP medication will be changed.
Interventions
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Chronotherapy
Patients identified with nocturnal hypertension while treated with blood pressure medications will have one medication switched from daytime to night time dosing in the following preference:
1. ACE or ARB
2. Calcium Channel Blockers
3. Alpha Blocker
4. Beta Blocker
If patient is on only one daytime BP medication, it will be switched to night time dosing. No dose adjustments will be made nor any new medications will be added. Only timing of BP medication will be changed.
Eligibility Criteria
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Inclusion Criteria
2. Age between 18 years to 70 years.
3. Known history of HTN on one or more anti-hypertensive medication.
4. Stable anti-hypertensive regimen for past 2 months
5. One of the anti-hypertensive regimen must include an ACE inhibitor, or an angiotensin receptor blocker, calcium channel blocker, alpha or beta blocker.
6. Stable immunosuppressive regimen with no dose changes in past 3 months.
7. No hospitalizations for previous 2 months
Exclusion Criteria
2. History of falls
3. Presence of AVF or AVG in both the arms
4. Inability to follow up in renal transplant clinic.
5. History of Atrial fibrillation.
6. Pregnant Women
7. Parkinson's Disease
8. Severe orthostatic Hypotension
9. Severe autonomic dysfunction
10. History of other transplanted organs
18 Years
70 Years
ALL
No
Sponsors
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Northwell Health
OTHER
Responsible Party
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North Shore LIJ
Principal Investigators
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Rajiv Vij, MD MPH
Role: PRINCIPAL_INVESTIGATOR
North Shore Long Island Jewish Hospital
Kenar Jhaveri, MD
Role: PRINCIPAL_INVESTIGATOR
North Shore Long Island Jewish Hospital
Locations
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North Shore Long Island Jewish Hospital
Great Neck, New York, United States
Countries
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References
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Paoletti 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.
Paoletti E, Bellino D, Amidone M, Rolla D, Cannella G. Relationship between arterial hypertension and renal damage in chronic kidney disease: insights from ABPM. J Nephrol. 2006 Nov-Dec;19(6):778-82.
McGlothan KR, Wyatt RJ, Ault BH, Hastings MC, Rogers T, DiSessa T, Jones DP. Predominance of nocturnal hypertension in pediatric renal allograft recipients. Pediatr Transplant. 2006 Aug;10(5):558-64. doi: 10.1111/j.1399-3046.2006.00521.x.
Stenehjem AE, Gudmundsdottir H, Os I. Office blood pressure measurements overestimate blood pressure control in renal transplant patients. Blood Press Monit. 2006 Jun;11(3):125-33. doi: 10.1097/01.mbp.0000209080.24870.2d.
Oliveras A, Vazquez S, Hurtado S, Vila J, Puig JM, Lloveras J. Ambulatory blood pressure monitoring in renal transplant patients: modifiable parameters after active antihypertensive treatment. Transplant Proc. 2004 Jun;36(5):1352-4. doi: 10.1016/j.transproceed.2004.04.085.
Covic A, Segall L, Goldsmith DJ. Ambulatory blood pressure monitoring in renal transplantation: should ABPM be routinely performed in renal transplant patients? Transplantation. 2003 Dec 15;76(11):1640-2. doi: 10.1097/01.TP.0000091288.19441.E2.
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.
Hermida RC, Ayala DE. Chronotherapy with the angiotensin-converting enzyme inhibitor ramipril in essential hypertension: improved blood pressure control with bedtime dosing. Hypertension. 2009 Jul;54(1):40-6. doi: 10.1161/HYPERTENSIONAHA.109.130203. Epub 2009 May 11.
Hermida RC, Ayala DE, Fernandez JR, Calvo C. Chronotherapy improves blood pressure control and reverts the nondipper pattern in patients with resistant hypertension. Hypertension. 2008 Jan;51(1):69-76. doi: 10.1161/HYPERTENSIONAHA.107.096933. Epub 2007 Oct 29.
Hermida RC, Ayala DE, Mojon A, Fernandez JR. Chronotherapy with nifedipine GITS in hypertensive patients: improved efficacy and safety with bedtime dosing. Am J Hypertens. 2008 Aug;21(8):948-54. doi: 10.1038/ajh.2008.216. Epub 2008 Jul 3.
Hermida RC, Calvo C, Ayala DE, Lopez JE, Rodriguez M, Chayan L, Mojon A, Fontao MJ, Fernandez JR. Dose- and administration time-dependent effects of nifedipine gits on ambulatory blood pressure in hypertensive subjects. Chronobiol Int. 2007;24(3):471-93. doi: 10.1080/07420520701420683.
Minutolo R, Gabbai FB, Borrelli S, Scigliano R, Trucillo P, Baldanza D, Laurino S, Mascia S, Conte G, De Nicola L. Changing the timing of antihypertensive therapy to reduce nocturnal blood pressure in CKD: an 8-week uncontrolled trial. Am J Kidney Dis. 2007 Dec;50(6):908-17. doi: 10.1053/j.ajkd.2007.07.020.
Vij R, Peixoto AJ. Management of nocturnal hypertension. Expert Rev Cardiovasc Ther. 2009 Jun;7(6):607-18. doi: 10.1586/erc.09.42.
Other Identifiers
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10-015A
Identifier Type: -
Identifier Source: org_study_id
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