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Mechanisms and Treatment of Intradialytic Hypertension

NCT ID: NCT00827775

Last Updated: 2020-11-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Intradialytic Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type ACTIVE_COMPARATOR

Carvedilol

Intervention Type DRUG

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

Interventions

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Carvedilol

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Peter Van Buren

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jula K Inrig, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

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UTSW Oakcliff Davita Dialysis

Dallas, Texas, United States

Site Status

UTSW Dallas East Davita Dialysis (Buckner unit)

Dallas, Texas, United States

Site Status

UTS Dallas Dialysis (Elmbrook)

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22700888 (View on PubMed)

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.

Reference Type RESULT
PMID: 21757643 (View on PubMed)

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.

Reference Type RESULT
PMID: 21734087 (View on PubMed)

Other Identifiers

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NIH K23 HL092297

Identifier Type: -

Identifier Source: secondary_id

STU 102008-042

Identifier Type: -

Identifier Source: org_study_id