Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Mechanisms and Treatment of Intradialytic Hypertension (MATCH)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jula K Inrig, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00827775
First received: January 21, 2009
Last updated: January 27, 2014
Last verified: January 2014

January 21, 2009
January 27, 2014
June 2009
September 2010   (final data collection date for primary outcome measure)
Endothelial progenitor cells [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00827775 on ClinicalTrials.gov Archive Site
flow mediated vasodilation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Mechanisms and Treatment of Intradialytic Hypertension
Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients
  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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Intradialytic Hypertension
Drug: Carvedilol
Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
September 2010
September 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00827775
102008-042, NIH K23 HL092297
Yes
Jula K Inrig, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Jula K Inrig, MD, MHS UT Southwestern Medical Center
University of Texas Southwestern Medical Center
January 2014

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