Preventing Outcomes Through Effective Cardiovascular Risk Reduction After Transplant II

NCT02003469 | Completed DMC

• 1 other identifier: HUM00028634
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

hypertension; kidney disease; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Change in ABPM pattern following donation/transplantation

  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

  12 months

Secondary Outcomes (4)

• Fatal and Non-Fatal Cardiovascular Events

  5 years

• Death

  5 years

• Allograft Failure

  5 years

• kidney function

  12 months

Study Arms (1)

Ambulatory Blood Pressure Monitoring

EXPERIMENTAL

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

Interventions

Ambulatory Blood Pressure Monitoring DEVICE

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

Also known as: Spacelabs Healthcare ambulatory blood pressure monitors

Ambulatory Blood Pressure Monitoring

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Inability to provide informed consent

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

UMichigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• Marcen R. Cardiovascular risk factors in renal transplantation--current controversies. Nephrol Dial Transplant. 2006 Jul;21 Suppl 3:iii3-8. doi: 10.1093/ndt/gfl298.

  PMID: 16815854 BACKGROUND

• Jardine AG, Fellstrom B, Logan JO, Cole E, Nyberg G, Gronhagen-Riska C, Madsen S, Neumayer HH, Maes B, Ambuhl P, Olsson AG, Pedersen T, Holdaas H. Cardiovascular risk and renal transplantation: post hoc analyses of the Assessment of Lescol in Renal Transplantation (ALERT) Study. Am J Kidney Dis. 2005 Sep;46(3):529-36. doi: 10.1053/j.ajkd.2005.05.014.

  PMID: 16129216 BACKGROUND

MeSH Terms

Conditions

Hypertension; Kidney Diseases; Cardiovascular Diseases

Interventions

Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Vascular Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Silas P Norman, MD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: April 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)