Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study

NCT01120613 | Withdrawn

• 1 other identifier: 10-015A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension (HTN) affects up to 75% of kidney transplant recipients and is associated with premature death. Nocturnal HTN is a common complication of ongoing essential HTN or a secondary cause of HTN. Both the non dipping of systolic blood pressure (SBP) at night time and the reverse dipping is associated with increased target organ damage and adverse cardiovascular outcomes and possibly allograft survival. Treatment of Nocturnal HTN is critical. Chronotherapy has been shown to be effective in halting progression in patients with diabetic nephropathy and chronic kidney disease. There is not enough data on prevalence and management of nocturnal HTN in transplant patients, which is the object of this study.

Conditions

Hypertension

Keywords

Nocturnal Hypertension; Nondipping; Renal Transplant; Chronotherapy

Outcome Measures

Primary Outcomes (1)

• Percent drop in mean SBP at night time compared to mean SBP at day time

  2 months

Secondary Outcomes (3)

• Urine Microalbumin to creatinine ratio

  2 months

• Change in Glomerular filtration rate as measured by MDRD equation.

  2 months

• 24 hour mean systolic Blood Pressure (SBP) Control

  2 months

Study Arms (1)

chronotherapy

EXPERIMENTAL

Patients identified with Nocturnal Hypertension, will have one of the blood pressure medications switched from daytime dosing to nighttime dosing

Drug: Chronotherapy

Interventions

Chronotherapy DRUG

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.

chronotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Renal transplant more than 1 year ago and not on dialysis.
• Age between 18 years to 70 years.
• Known history of HTN on one or more anti-hypertensive medication.
• Stable anti-hypertensive regimen for past 2 months
• One of the anti-hypertensive regimen must include an ACE inhibitor, or an angiotensin receptor blocker, calcium channel blocker, alpha or beta blocker.
• Stable immunosuppressive regimen with no dose changes in past 3 months.
• No hospitalizations for previous 2 months

You may not qualify if:

• Inability to consent
• History of falls
• Presence of AVF or AVG in both the arms
• Inability to follow up in renal transplant clinic.
• History of Atrial fibrillation.
• Pregnant Women
• Parkinson's Disease
• Severe orthostatic Hypotension
• Severe autonomic dysfunction
• History of other transplanted organs

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

North Shore Long Island Jewish Hospital

Great Neck, New York, 11020, United States

Location

Related Publications (13)

• 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.

  PMID: 19543066 BACKGROUND

• 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.

  PMID: 17173252 BACKGROUND

• 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.

  PMID: 16856991 BACKGROUND

• 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.

  PMID: 16702821 BACKGROUND

• 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.

  PMID: 15251330 BACKGROUND

• 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.

  PMID: 14702541 BACKGROUND

• 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.

  PMID: 12692568 BACKGROUND

• 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.

  PMID: 19433778 BACKGROUND

• 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.

  PMID: 17968001 BACKGROUND

• 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.

  PMID: 18600215 BACKGROUND

• 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.

  PMID: 17612946 BACKGROUND

• 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.

  PMID: 18037091 BACKGROUND

• Vij R, Peixoto AJ. Management of nocturnal hypertension. Expert Rev Cardiovasc Ther. 2009 Jun;7(6):607-18. doi: 10.1586/erc.09.42.

  PMID: 19505276 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Chronotherapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Rajiv Vij, MD MPH

  North Shore Long Island Jewish Hospital

  PRINCIPAL INVESTIGATOR

• Kenar Jhaveri, MD

  North Shore Long Island Jewish Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 11, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2010
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

US (1)