Mechanisms and Treatment of Intradialytic Hypertension (MATCH)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jula K Inrig, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00827775
First received: January 21, 2009
Last updated: January 27, 2014
Last verified: January 2014
  Purpose
  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.

Condition Intervention Phase
Intradialytic Hypertension
Drug: Carvedilol
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Endothelial progenitor cells [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • flow mediated vasodilation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827775

Locations
United States, Texas
UTS Dallas Dialysis (Elmbrook)
Dallas, Texas, United States, 75247
UTSW Oakcliff Davita Dialysis
Dallas, Texas, United States, 75224
UTSW Dallas East Davita Dialysis (Buckner unit)
Dallas, Texas, United States, 75228
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Jula K Inrig, MD, MHS UT Southwestern Medical Center
  More Information

Publications:
Responsible Party: Jula K Inrig, Assistant Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00827775     History of Changes
Other Study ID Numbers: 102008-042, NIH K23 HL092297
Study First Received: January 21, 2009
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Hypertension
Hemodialysis

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on July 29, 2014