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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

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.

Condition or disease Intervention/treatment Phase
Intradialytic Hypertension Drug: Carvedilol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
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
Study Start Date : June 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Carvedilol

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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)

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
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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
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Principal Investigator: Jula K Inrig, MD, MHS UT Southwestern Medical Center
Publications of Results:
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Responsible Party: Peter Van Buren, Associate Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00827775    
Other Study ID Numbers: STU 102008-042
NIH K23 HL092297
First Posted: January 23, 2009    Key Record Dates
Results First Posted: November 3, 2020
Last Update Posted: November 3, 2020
Last Verified: October 2020
Keywords provided by Peter Van Buren, University of Texas Southwestern Medical Center:
Hypertension
Hemodialysis
Additional relevant MeSH terms:
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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
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists