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HypertensionNCT01120613

Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study

A study testing Chronotherapy in people with Hypertension, run by Northwell Health at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hypertension
What is being tested?
Chronotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2010to Aug 2010
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Parkinson's Disease
  • Severe orthostatic Hypotension
  • Severe autonomic dysfunction
  • History of other transplanted organs

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Shore Long Island Jewish Hospital

    Great Neck, New York, 11020

Other trials in United States

About this study

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
Being tested
Chronotherapy
Keywords
Nocturnal Hypertension, Nondipping, Renal Transplant, Chronotherapy
Medical subject headings
Hypertension

What participants receive

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

  • ChronotherapyDrug

    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.

Study groups in NCT01120613
Study groupRoleWhat they receive
chronotherapyExperimentalPatients identified with Nocturnal Hypertension, will have one of the blood pressure medications switched from daytime dosing to nighttime dosing
Receives: Drug: Chronotherapy

What is being measured

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

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

    Measured: 2 months

Secondary outcomes (3)

  1. Urine Microalbumin to creatinine ratio

    Measured: 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.

    Measured: 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.

    Measured: 2 months

Timeline

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

  1. First posted11 May 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionAug 2010 (estimated)

Why it stopped: primary investigator left institution; not enough patients

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01120613
Sponsor's protocol ID
10-015A
Status last verified
May 2013
First submitted
29 Apr 2010
Last updated
30 May 2013
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Chronotherapy in people with Hypertension, run by Northwell Health 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 7 inclusion and 10 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: withdrawn, 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 was withdrawn before enrolling participants, so there are no results.

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 at day time (time frame: 2 months). 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 NCT01120613, 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 30 May 2013.

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