Completed

NCT Number: NCT00827775

Mechanisms and Treatment of Intradialytic Hypertension

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.

Completed

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Key information

Conditions

Intradialytic Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UTS Dallas Dialysis (Elmbrook), Dallas, Texas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Carvedilol

Drug

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

Primary outcomes

Endothelial Progenitor Cells

Time frame: 12 weeks
- 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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: MATCH

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jan 23, 2009
Registry last updated: Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed