Mechanism and Treatment of Intradialytic Hypertension

This study is not yet open for participant recruitment.

Verified by University of Texas Southwestern Medical Center, January 2009

First Received: January 21, 2009 Last Updated: January 22, 2009 History of Changes

Sponsors and Collaborators:	University of Texas Southwestern Medical Center National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00827775

Purpose

To determine in a cross sectional case-controlled cohort study of 50 hemodialysis patients if blood pressure elevations with hemodialysis are associated with increased vascular stiffness (measured by pulse wave velocity) and/or 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
To determine if lowering blood pressure with carvedilol in 25 ESRD subjects with blood pressure elevations with hemodialysis can improve vascular stiffness and/or endothelial cell dysfunction as surrogate mechanistic markers for improving cardiovascular outcomes.

Condition	Intervention	Phase
Intradialytic Hypertension	Drug: Carvedilol	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients

Resource links provided by NLM:

MedlinePlus related topics: Dialysis High Blood Pressure Kidney Failure

Drug Information available for: Carvedilol

U.S. FDA Resources

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 ]

Estimated Enrollment:	50
Study Start Date:	March 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control: No Intervention 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 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 maximun of 25 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 > 60 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 neovascularization present, such as neoplasm, active wounds, or significant retinopathy
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

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

Contacts

Contact: Jula K Inrig, MD, MHS	214-645-8263	jula.inrig@utsouthwestern.edu
Contact: Tammy Lightfoot, RN	214-645-8265	tammy.lightfoot@utsouthwestern.edu

Sponsors and Collaborators

University of Texas Southwestern Medical Center

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Jula K Inrig, MD, MHS

UT Southwestern Medical Center

More Information

No publications provided

Responsible Party:	UT Southwestern ( Jula K Inrig, MD, MHS )
Study ID Numbers:	102008-042, NIH K23 HL092297
Study First Received:	January 21, 2009
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00827775 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:

Hypertension
Hemodialysis

Study placed in the following topic categories:

Vasodilator Agents
Neurotransmitter Agents
Adrenergic Agents
Vascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists

Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents
Carvedilol
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vascular Diseases
Adrenergic alpha-Antagonists
Cardiovascular Agents

Antihypertensive Agents
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Hypertension
Carvedilol

ClinicalTrials.gov processed this record on September 11, 2009