Mechanisms and Treatment of Intradialytic Hypertension (MATCH)

October 12, 2020 updated by: Peter Van Buren, University of Texas Southwestern Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75224
        • UTSW Oakcliff Davita Dialysis
      • Dallas, Texas, United States, 75228
        • UTSW Dallas East Davita Dialysis (Buckner unit)
      • Dallas, Texas, United States, 75247
        • UTS Dallas Dialysis (Elmbrook)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 21, 2009

First Submitted That Met QC Criteria

January 22, 2009

First Posted (Estimate)

January 23, 2009

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

October 12, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 102008-042
  • NIH K23 HL092297

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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