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Mechanisms and Treatment of Intradialytic Hypertension (MATCH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00827775
First Posted: January 23, 2009
Last Update Posted: January 29, 2014
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jula K Inrig, University of Texas Southwestern Medical Center
  Purpose
  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.

Condition Intervention Phase
Intradialytic Hypertension Drug: Carvedilol Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients

Resource links provided by NLM:


Further study details as provided by Jula K Inrig, University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Endothelial progenitor cells [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • flow mediated vasodilation [ Time Frame: 8 weeks ]

Enrollment: 59
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Carvedilol
Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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): NCT00827775


Locations
United States, Texas
UTSW Oakcliff Davita Dialysis
Dallas, Texas, United States, 75224
UTSW Dallas East Davita Dialysis (Buckner unit)
Dallas, Texas, United States, 75228
UTS Dallas Dialysis (Elmbrook)
Dallas, Texas, United States, 75247
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jula K Inrig, MD, MHS UT Southwestern Medical Center
  More Information

Publications:
Responsible Party: Jula K Inrig, Assistant Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00827775     History of Changes
Other Study ID Numbers: 102008-042
NIH K23 HL092297
First Submitted: January 21, 2009
First Posted: January 23, 2009
Last Update Posted: January 29, 2014
Last Verified: January 2014

Keywords provided by Jula K Inrig, University of Texas Southwestern Medical Center:
Hypertension
Hemodialysis

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists