Mechanisms and Treatment of Intradialytic Hypertension
MATCH
Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients
2 other identifiers
interventional
55
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2009
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2009
CompletedFirst Posted
Study publicly available on registry
January 23, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
November 3, 2020
CompletedNovember 3, 2020
October 1, 2020
1.3 years
January 21, 2009
October 12, 2020
October 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endothelial Progenitor Cells
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 Outcomes (1)
Flow Mediated Vasodilation
12 weeks
Study Arms (2)
Control
NO INTERVENTIONPatients 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
Intervention
ACTIVE COMPARATORPatients 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
UTSW Oakcliff Davita Dialysis
Dallas, Texas, 75224, United States
UTSW Dallas East Davita Dialysis (Buckner unit)
Dallas, Texas, 75228, United States
UTS Dallas Dialysis (Elmbrook)
Dallas, Texas, 75247, United States
Related Publications (3)
Inrig JK, Van Buren P, Kim C, Vongpatanasin W, Povsic TJ, Toto R. Probing the mechanisms of intradialytic hypertension: a pilot study targeting endothelial cell dysfunction. Clin J Am Soc Nephrol. 2012 Aug;7(8):1300-9. doi: 10.2215/CJN.10010911. Epub 2012 Jun 14.
PMID: 22700888RESULTInrig JK, Van Buren P, Kim C, Vongpatanasin W, Povsic TJ, Toto RD. Intradialytic hypertension and its association with endothelial cell dysfunction. Clin J Am Soc Nephrol. 2011 Aug;6(8):2016-24. doi: 10.2215/CJN.11351210. Epub 2011 Jul 14.
PMID: 21757643RESULTVan Buren PN, Kim C, Toto R, Inrig JK. Intradialytic hypertension and the association with interdialytic ambulatory blood pressure. Clin J Am Soc Nephrol. 2011 Jul;6(7):1684-91. doi: 10.2215/CJN.11041210.
PMID: 21734087RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Van Buren
- Organization
- University of Texas Southwestern Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jula K Inrig, MD, MHS
University of Texas Southwestern Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
January 21, 2009
First Posted
January 23, 2009
Study Start
June 1, 2009
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
November 3, 2020
Results First Posted
November 3, 2020
Record last verified: 2020-10