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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Intradialytic Hypertension
Intervention Drug: Carvedilol
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Intervention
Hide Arm/Group Description 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

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

Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid

Period Title: Overall Study
Started 25 30
Completed 25 25
Not Completed 0 5
Reason Not Completed
Withdrawal by Subject             0             5
Arm/Group Title Control Intervention Total
Hide Arm/Group Description 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

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

Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid

Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
55.1  (7.9) 53.9  (11.1) 54.5  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
5
  20.0%
5
  20.0%
10
  20.0%
Male
20
  80.0%
20
  80.0%
40
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Hispanic or Latino
15
  60.0%
16
  64.0%
31
  62.0%
Not Hispanic or Latino
10
  40.0%
9
  36.0%
19
  38.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  40.0%
9
  36.0%
19
  38.0%
White
15
  60.0%
16
  64.0%
31
  62.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25
 100.0%
25
 100.0%
50
 100.0%
1.Primary Outcome
Title Endothelial Progenitor Cells
Hide Description
  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
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Follow up measurements were only obtained in the intervention subjects receiving carvedilol
Arm/Group Title Control Intervention
Hide Arm/Group Description:
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

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

Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid

Overall Number of Participants Analyzed 25 25
Median (Inter-Quartile Range)
Unit of Measure: % of mononuclear cells
Baseline ALDH bright Number Analyzed 25 participants 25 participants
0.052
(0.042 to 0.076)
0.034
(0.017 to 0.08)
Follow up ALDH bright Number Analyzed 0 participants 25 participants
0.027
(0.013 to 0.048)
Baseline CD34/CD133 endothelial progenitor cells Number Analyzed 25 participants 25 participants
0.059
(0.036 to 0.070)
0.033
(0.016 to 0.051)
Follow up CD34/CD133 Number Analyzed 0 participants 25 participants
0.029
(0.019 to 0.049)
2.Secondary Outcome
Title Flow Mediated Vasodilation
Hide Description 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
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Follow up measurements were only obtained in intervention subjects receiving carvedilol
Arm/Group Title Control Intervention
Hide Arm/Group Description:
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

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

Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: % dilation from baseline
Baseline FMD Number Analyzed 25 participants 25 participants
1.67  (1.24) 1.03  (0.7)
Follow Up FMD Number Analyzed 0 participants 25 participants
1.4  (0.84)
Time Frame First day of enrollment to end of study, an average 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Intervention
Hide Arm/Group Description 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

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

Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid

All-Cause Mortality
Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/25 (0.00%)    
Hide Serious Adverse Events
Control Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      5/25 (20.00%)    
Cardiac disorders     
Fluid Overload   0/25 (0.00%)  0 2/25 (8.00%)  2
Gastrointestinal disorders     
Gastroparesis   0/25 (0.00%)  0 1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumonia   0/25 (0.00%)  0 1/25 (4.00%)  1
Vascular disorders     
Hemodialysis Access Revision   0/25 (0.00%)  0 1/25 (4.00%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      22/25 (88.00%)    
Cardiac disorders     
Symptomatic Intradialytic Hypotension  [1]  0/25 (0.00%)  0 22/25 (88.00%)  22
Indicates events were collected by systematic assessment
[1]
There were 22 episodes total out of 920 dialysis treatments among the 25 patients
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter Van Buren
Organization: University of Texas Southwestern Medical Center
Phone: 214-645-8293
EMail: peter.vanburen@utsouthwestern.edu
Layout table for additonal information
Responsible Party: Peter Van Buren, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00827775    
Other Study ID Numbers: STU 102008-042
NIH K23 HL092297
First Submitted: January 21, 2009
First Posted: January 23, 2009
Results First Submitted: October 12, 2020
Results First Posted: November 3, 2020
Last Update Posted: November 3, 2020