Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study

May 29, 2013 updated by: Northwell Health
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Great Neck, New York, United States, 11020
        • North Shore Long Island Jewish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chronotherapy
Patients identified with Nocturnal Hypertension, will have one of the blood pressure medications switched from daytime dosing to nighttime dosing
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent drop in mean SBP at night time compared to mean SBP at day time
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine Microalbumin to creatinine ratio
Time Frame: 2 months
2 months
Change in Glomerular filtration rate as measured by MDRD equation.
Time Frame: 2 months
Serum creatinine as a measure of kidney function will be measured at the begining and end of intervention.
2 months
24 hour mean systolic Blood Pressure (SBP) Control
Time Frame: 2 months
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Rajiv Vij, MD MPH, North Shore Long Island Jewish Hospital
  • Principal Investigator: Kenar Jhaveri, MD, North Shore Long Island Jewish Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

April 29, 2010

First Submitted That Met QC Criteria

May 7, 2010

First Posted (Estimate)

May 11, 2010

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-015A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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