Mechanisms of Increased Ambulatory Blood Pressure in Patients With Intradialytic Hypertension

Completed

• Conditions: Intradialytic Hypertension
• Interventions: Drug: Carvedilol vs. Prazosin

• Registration Number: NCT01862497
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

The purpose of this study is 1) to determine what physiologic factors (extracellular fluid overload or vasoconstriction) contribute more to increased blood pressure levels between dialysis treatments in hemodialysis patients whose blood pressure increases and decreases during hemodialysis and 2) to determine whether carvedilol provides better control of blood pressure between dialysis treatments than prazosin in patients whose blood pressure increases during dialysis.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-05-18
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-24
• Status Verified: 2018-04
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

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Exclusion Criteria

For Aims 1 and 2:

• Hemodialysis vintage less than 1 month
• Amputated arm or leg
• Presence of cardiac defibrillator or pacemaker
• Presence of large metal prosthesis
• Failure to achieve dry weight

For Case subjects participating in Aim 3:

• Patients with a specific indication for beta blocker therapy including systolic heart failure, history of myocardial infarction, history of tachyarrhythmia or angina being managed with beta blocker therapy.
• Patients with contraindications to beta blockade including bradycardia (heart rate less than 60 beats per minute) while not on a pulse lowering drug, severe reactive airway disease, prior intolerance to beta blocker therapy
• Prior intolerance to alpha blocker therapy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carvedilol (for Aim 3 only)	Carvedilol vs. Prazosin	Eligible case subjects from aims 1-2 will participate in a randomized crossover study where each subject will receive carvedilol and prazosin for 8 weeks each(under randomized treatment sequence) with a 1 week washout period included in between treatments. The first arm will include subjects that are assigned to the randomization sequence: Carvedilol x 8 weeks (titrated up to 50 mg po bid), washout x 1 week, Prazosin x 8 weeks (titrated up to 16 mg daily)
Prazosin (for Aim 3 only)	Carvedilol vs. Prazosin	Eligible case subjects from aims 1-2 will participate in a randomized crossover study where each subject will receive carvedilol and prazosin for 8 weeks each(under randomized treatment sequence) with a 1 week washout period included in between treatments. The first arm will include subjects that are assigned to the randomization sequence: Prazosin x 8 weeks, washout x 1 week, Carvedilol x 8 weeks

Primary Outcome Measures

Name	Time	Method
Ratio of Extracellular Body Water to Total Body Water	Expected recruitment is 4-5 years

Secondary Outcome Measures

Name	Time	Method
Change in Endothelin-1 from pre to post dialysis	Expected recruitment is 4-5 years

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States