Mechanisms and Treatment of Intradialytic Hypertension - Full Text View

Sponsor:	University of Texas Southwestern Medical Center
Collaborator:	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 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 endothelial cell dysfunction as a surrogate mechanistic marker for improving cardiovascular outcomes.

Condition	Intervention	Phase
Intradialytic Hypertension	Drug: Carvedilol	Phase IV

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:

MedlinePlus related topics: Dialysis High Blood Pressure

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:	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

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

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Jula K Inrig, MD, MHS

UT Southwestern Medical Center

More Information

No publications provided by University of Texas Southwestern Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Jul 14.

Responsible Party:	Jula K Inrig, MD, MHS, UT Southwestern
ClinicalTrials.gov Identifier:	NCT00827775 History of Changes
Other Study ID Numbers:	102008-042, NIH K23 HL092297
Study First Received:	January 21, 2009
Last Updated:	August 2, 2011
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 February 09, 2012