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Preventing Outcomes Through Effective Cardiovascular Risk Reduction After Transplant II (PROTECTII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003469
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Silas P. Norman, University of Michigan

Brief Summary:

Background and Rationale Cardiovascular disease is highly prevalent in the kidney transplant population, accounting for approximately 40% of all deaths and significant morbidity. The morbidity and mortality experienced by kidney transplant recipient's results from an excess of pre-transplant risk factors that are exacerbated by kidney transplantation along with the development of novel risk factors. Hypertension (HTN) is the most consistent cardiovascuar disease risk factor in transplant recipients..

A large number of studies have been done in the general population comparing ambulatory blood pressure monitoring (ABPM) to casual, office based and home measures of blood pressure (BP). The results have clearly demonstrated that ABPM gives a more accurate representation of BP and arguably should be used as part of routine patient care. ABPM has been shown to reveal patients both with white-coat and with masked HTN, nocturnal HTN and lack of nocturnal dipping. Ambulatory BP measures afford us a non-invasive, highly accurate way to evaluate and treat kidney transplant recipients.

Live kidney donors (LKD) have significantly expanded the supply of critical organs. Of paramount importance of course has always been donor safety. As a result, candidates are known to be healthy at the time of donation. Ambulatory blood pressure monitoring allows a unique opportunity to examine the effects of live kidney donation on the blood pressure profiles of LKD.

Methods Study Design: Prospective, 5-year, single center study of ABPM, cardiovascular and graft outcomes in incident and prevalent live kidney donors, kidney and kidney-pancreas transplant candidates and recipients.


Condition or disease Intervention/treatment Phase
Hypertension Device: Ambulatory Blood Pressure Monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Outcomes Through Effective Cardiovascular Risk Reduction After Transplant II
Study Start Date : April 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ambulatory Blood Pressure Monitoring
All enrolled patients have an ambulatory blood pressure monitor placed, pre-transplant/donation, again at 3 months and finally at 12 months post-transplant/donation to measure blood pressure and blood pressure patterns
Device: Ambulatory Blood Pressure Monitoring
All enrolled patients have an ambulatory blood pressure monitor placed, pre-transplant/donation, again at 3 months and finally at 12 months post-transplant/donation to measure blood pressure and blood pressure patterns
Other Name: Spacelabs Healthcare ambulatory blood pressure monitors




Primary Outcome Measures :
  1. Change in ABPM pattern following donation/transplantation [ Time Frame: 12 months ]
    We reassessed the ABPM pattern prior to, early after and 12 months after kidney transplant or live kidney donation to look for changes consistent with onset hypertension


Secondary Outcome Measures :
  1. Fatal and Non-Fatal Cardiovascular Events [ Time Frame: 5 years ]
    Fatal and non-fatal cardiovascular events, including myocardial infarction, congestive heart failure, coronary angioplasty, coronary artery bypass grafting, cardiac arrhythmias, sudden cardiac death, transient ischemic attack, stroke, carotid endarterectomy, aortic dissection, new peripheral vascular disease diagnosis or intervention.

  2. Death [ Time Frame: 5 years ]
    Death from any cause

  3. Allograft Failure [ Time Frame: 5 years ]
    Allograft failure, regardless of cause

  4. kidney function [ Time Frame: 12 months ]
    kidney function calculated at 12 months post-donation or post-transplant



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult (age > 18 years) live donor candidates being evaluated by the U of M transplant center
  • All adult (age > 18 years)kidney/kidney-pancreas candidates being evaluated by the U of M transplant center
  • All adult (age >18 years) live donors or successful kidney/kidney-pancreas recipients.

Exclusion Criteria:

  • Inability to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003469


Locations
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United States, Michigan
UMichigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Silas P Norman, MD, MPH University of Michigan
Publications:
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Responsible Party: Silas P. Norman, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02003469    
Other Study ID Numbers: HUM00028634
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silas P. Norman, University of Michigan:
hypertension
kidney disease
cardiovascular disease
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases