A Prospective Randomized Study to Investigate the Effect of Extracorporeal Shockwave Lithotripsy on Blood Pressure Control in Patients With Hypertension - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The changes in mean 24hr systolic and diastolic blood pressure measurement
研究概览
简要总结
Having the advantages of being minimally invasive and simple, extracorporeal shock wave lithotripsy (SWL) remains one of the treatment options for renal stones less than 2cm. Although SWL is the most minimally invasive surgical approach for stone, there are still some concern about its short and long term side effect. While, there are some evidences that SWL might lead to increase in new onset hypertension, investigator's recent study suggested it might also cause worsening of blood pressure control in patient with known hypertension. Therefore, further studies are needed to confirm the initial finding. This study recruits patients who have hypertension and are currently diagnosed to have renal stone and planned for SWL, in order to to investigate the effect of SWL on blood pressure control.
After informed consent and background information have been obtained, patients will be randomized to either have routine SWL (treatment arm) or 6 months later (control arm). Group 1 patients will have blood pressure monitored for one day at home by an handy automated blood pressure measuring machine before SWL and 6 months after SWL. Group 2 patients will have blood pressure monitoring immediately and then 6 months later, just prior to the SWL.
详细描述
BACKGROUND
Extracorporeal shock wave lithotripsy (SWL) was first introduced in early 1980's for the management of urolithiasis. The advantage of being minimally invasive, when compared to other procedures for stone treatment, made SWL remain one of the treatment options for renal stones less than 2 cm in the latest guidelines.
Despite considered as the most non-invasive treatment for urinary calculi, there are still many concerns about the long-term consequence of SWL. In particular, the effect of SWL on blood pressure is still a controversy topic. In the recent study, investigator has observed approximately 20% of subjects experienced worsened blood pressure control during the 2-year follow-up period, including 20/202 (9.95%) previously non-hypertensive subjects who developed new onset hypertension. The observed incidence of new-onset hypertension was quite similar those in some reported series. In the literature, there were multiple reports, including case series and hospital data analyses, 7-9 of development of new-onset hypertension after SWL. Unfortunately, most of those studies were retrospective and used different definitions of hypertension.
But the high incidence of worsening blood pressure control, including 43 (36.4%) of 118 hypertensive subjects who required add-on antihypertensive therapies, observed in our study was alarming. Because most studies in the literature were just focused on development of new-onset hypertension, investigator's observation provides supplementary information about potential effects of SWL on pre-existing hypertension. In general, the average annual incidence of add-on pharmacotherapy among local hypertensive patients was 4.71-6.41%. 10 Therefore, the add-on therapy rate of 36.4% during the 2-year follow-up was much higher than that in the general population. Unfortunately, investigator did not include a non-interventional arm for comparison in the previous study and could not conclude that this outcome was solely attributable to SWL.
Therefore, investigator would like to propose a prospective study to assess the effect SWL on the blood pressure control in patients with known hypertension. Investigator hope the study results will provide additional information on the long-term effect of SWL on patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal calculi of size 5-15 mm in maximal diameter and considered as suitable for SWL
- •Patient with known hypertension and on regular medical treatment with regular follow-up.
- •Patient with stable hypertension for at least 3 months
排除标准
- •Patients had previous SWL, kidney surgery, percutaneous nephrolithotomy, etc.
- •Patients with stones obviously required more than one section of SWL
研究组 & 干预措施
Treatment Arm
immediate extracorporeal shock wave lithotripsy - subject will have SWL arranged in the next available list
干预措施: Extracorporeal shock wave lithotripsy (Procedure)
Control Arm
delayed extracorporeal shock wave lithotripsy - subject will have SWL done 6 months later
结局指标
主要结局
The changes in mean 24hr systolic and diastolic blood pressure measurement
时间窗: Baseline, 6 months
For treatment arm, the changes in mean 24hr systolic and diastolic blood pressure measurement before SWL and 6 monthes after SWL For control arm, the changes in mean 24hr systolic and diastolic blood pressure measurement right after randomization and in 6 months.
次要结局
- The need of add-on therapy for hypertension(6 months)
- Change in mean night time heart rate(Baseline, 6 months)
- Change in mean night time diastolic and systolic blood pressure(Baseline, 6 months)
- Change in mean afternoon/evening diastolic and systolic blood pressure(Baseline, 6 months)
- Change in mean afternoon/evening heart rate(Baseline, 6 months)
- Change in mean 24hr heart rate(Baseline, 6 months)
- Change in mean morning-time diastolic and systolic blood pressure(Baseline, 6 months)
- Change in mean morning-time heart rate(Baseline, 6 months)
- Any adverse effects after SWL(6 months)
研究者
Chi Fai NG
Clinical Professor
Chinese University of Hong Kong