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WithdrawnNCT01120613Updated May 30, 2013

Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study

An interventional study of Chronotherapy in Hypertension, sponsored by Northwell Health. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-05-30.

Sponsored by Northwell Health · Not applicable, Interventional, and Treatment

Why this study was withdrawn
primary investigator left institution; not enough patients
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Hypertension

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Keywords

  • Nocturnal Hypertension
  • Nondipping
  • Renal Transplant
  • Chronotherapy
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In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

Browse Hypertension studies →

Lead sponsor

Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.

Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Renal transplant more than 1 year ago and not on dialysis.
  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

Exclusion Criteria:

  1. Inability to consent
  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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    chronotherapy

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

    Drug: Chronotherapy

Interventions

  • DrugChronotherapy

    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.

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What researchers measure

Primary outcomes

  1. Percent drop in mean SBP at night time compared to mean SBP at day time

    Time frame: 2 months

Secondary outcomes

  1. Urine Microalbumin to creatinine ratio

    Time frame: 2 months

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

    Serum creatinine as a measure of kidney function will be measured at the begining and end of intervention.

    Time frame: 2 months

  3. 24 hour mean systolic Blood Pressure (SBP) Control

    Ambulatory Blood pressure monitoring at the end of intervention will be used to assess 24 hour ( day and nighttime) blood pressure control We hypothesize that night time dosing of medication ( chronotherapy) will not only improve nocturnal hypertension but also improve awake blood pressure and overall 24 hour average SBP control.

    Time frame: 2 months

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Study locations

1 site
  • North Shore Long Island Jewish Hospital
    Great Neck, New York 11020, United States
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References and documents

Publications

  • 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. PubMed 19543066 ↗
  • 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. PubMed 17173252 ↗
  • 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. PubMed 16856991 ↗
  • 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. PubMed 16702821 ↗
  • 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. PubMed 15251330 ↗
  • 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. PubMed 14702541 ↗
  • 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 ↗
  • 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. PubMed 19433778 ↗
  • 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. PubMed 17968001 ↗
  • 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. PubMed 18600215 ↗
  • 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. PubMed 17612946 ↗
  • 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. PubMed 18037091 ↗
  • Vij R, Peixoto AJ. Management of nocturnal hypertension. Expert Rev Cardiovasc Ther. 2009 Jun;7(6):607-18. doi: 10.1586/erc.09.42. PubMed 19505276 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01120613
Lead sponsor
Northwell Health
First posted
May 11, 2010
Start date
Apr 2010
Primary completion
Aug 2010 (estimated)
Last update
May 30, 2013

Study contacts

Rajiv Vij, MD MPH
principal investigator · North Shore Long Island Jewish Hospital
Kenar Jhaveri, MD
principal investigator · North Shore Long Island Jewish Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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