Mechanisms and Treatment of Intradialytic Hypertension (MATCH)

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Intradialytic Hypertension

Treatments: Drug: Carvedilol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00827775

STU 102008-042

NIH K23 HL092297

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Control

No Intervention 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

Intervention

Active Comparator group

Description:

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

Treatment:

Drug: Carvedilol