Mechanisms and Treatment of Intradialytic Hypertension

Intradialytic Hypertension Clinical Trial

— MATCH  

Official title:

Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827775
• Other study ID #: STU 102008-042
• Secondary ID: NIH K23 HL092297
• Status: Completed
• Phase: Phase 4
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: October 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Intradialytic Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	UTS Dallas Dialysis (Elmbrook)	Dallas	Texas
United States	UTSW Dallas East Davita Dialysis (Buckner unit)	Dallas	Texas
United States	UTSW Oakcliff Davita Dialysis	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Inrig 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. — View Citation

Van 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Progenitor Cells	ALDH bright cells reported as percentage of mononuclear cells. These were assayed using flow cytometry; CD34/CD133 endothelial progenitor cells reported as percentage of mononuclear cells. These were assayed using flow cytometry	12 weeks
Secondary	Flow Mediated Vasodilation	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