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Mechanisms and Treatment of Intradialytic Hypertension (MATCH)

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ClinicalTrials.gov Identifier: NCT00827775
Recruitment Status : Completed
First Posted : January 23, 2009
Results First Posted : November 3, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Peter Van Buren, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE January 21, 2009
First Posted Date  ICMJE January 23, 2009
Results First Submitted Date  ICMJE October 12, 2020
Results First Posted Date  ICMJE November 3, 2020
Last Update Posted Date November 3, 2020
Study Start Date  ICMJE June 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2020)
Endothelial Progenitor Cells [ Time Frame: 12 weeks ]
  1. ALDH bright cells reported as percentage of mononuclear cells. These were assayed using flow cytometry
  2. CD34/CD133 endothelial progenitor cells reported as percentage of mononuclear cells. These were assayed using flow cytometry
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2009)
Endothelial Progenitor Cells [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2020)
Flow Mediated Vasodilation [ Time Frame: 12 weeks ]
Measured as percent change in brachial artery diameter from baseline to post shear stress for an individual measurement. Follow up measurements were obtained in intervention subjects 12 weeks later
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2009)
Flow Mediated Vasodilation [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mechanisms and Treatment of Intradialytic Hypertension
Official Title  ICMJE Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients
Brief Summary
  1. To determine in a cross sectional case-controlled cohort study of 50 hemodialysis patients if blood pressure elevations with hemodialysis are associated with decreased endothelial cell function (measured by brachial artery flow mediated dilation and endothelial progenitor cell number), both of which are novel mechanistic markers in the causal pathway for detrimental cardiovascular outcomes; and
  2. To determine if lowering blood pressure with carvedilol in 25 ESRD subjects with blood pressure elevations with hemodialysis can improve endothelial cell dysfunction as a surrogate mechanistic marker for improving cardiovascular outcomes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intradialytic Hypertension
Intervention  ICMJE Drug: Carvedilol
Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
Study Arms  ICMJE
  • No Intervention: Control
    Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling >10 mmhg for more than 4/6 of the last dialysis treatment sessions
  • Active Comparator: Intervention
    Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of >10 mmhg for more than 4/6 of the last dialysis treatment sessions
    Intervention: Drug: Carvedilol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2020)
55
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2009)
50
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • on hemodialysis > 30 days
  • aged 18 to 80 years old
  • ability to provide informed consent
  • Primary nephrologist deems patient is at target dry weight
  • Predialysis SBP >140 or postdialysis SBP>130

Exclusion Criteria:

  • Patients with active wounds
  • Blood pressure unable to be measured by routine mechanisms in the upper extremity
  • Change in blood pressure medications in the previous 2 weeks
  • Intolerance of beta or alpha-blockers
  • pregnancy
  • Resting heart rate <50
  • Life expectancy < 6 months
  • Current therapy with carvedilol or contraindication to carvedilol (ONLY in the intervention arm)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00827775
Other Study ID Numbers  ICMJE STU 102008-042
NIH K23 HL092297
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Van Buren, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Jula K Inrig, MD, MHS UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP