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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Ratio of Extracellular Body Water to Total Body Water
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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
研究组 & 干预措施
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)
干预措施: 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
干预措施: Carvedilol vs. Prazosin (Drug)
结局指标
主要结局
Ratio of Extracellular Body Water to Total Body Water
时间窗: Expected recruitment is 4-5 years
次要结局
- Change in Endothelin-1 from pre to post dialysis(Expected recruitment is 4-5 years)
研究者
Peter Van Buren
Assistant Professor
University of Texas Southwestern Medical Center