Mechanism of Increased Ambulatory Blood Pressure in Patients With Intradialytic Hypertension and Hemodialysis Controls: A Case Control Study and Crossover Trial Comparing Carvedilol and Prazosin Hydrochloride
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Ratio of Extracellular Body Water to Total Body Water
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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
Arms & Interventions
Carvedilol (for Aim 3 only)
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)
Intervention: Carvedilol vs. Prazosin (Drug)
Prazosin (for Aim 3 only)
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
Intervention: Carvedilol vs. Prazosin (Drug)
Outcomes
Primary Outcomes
Ratio of Extracellular Body Water to Total Body Water
Time Frame: Expected recruitment is 4-5 years
Secondary Outcomes
- Change in Endothelin-1 from pre to post dialysis(Expected recruitment is 4-5 years)
Investigators
Peter Van Buren
Assistant Professor
University of Texas Southwestern Medical Center