HypertensionNCT03714477
A Study to Investigate the Effect of Extracorporeal Shockwave Lithotripsy on Hypertension
A study testing Extracorporeal shock wave lithotripsy in people with Hypertension and Renal Stone, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Renal Stone
- What is being tested?
- Extracorporeal shock wave lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2021to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients had previous SWL, kidney surgery, percutaneous nephrolithotomy, etc.
- Patients with stones obviously required more than one section of SWL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Study to Investigate the Effect of Extracorporeal Shockwave Lithotripsy on Blood Pressure Control in Patients With Hypertension - a Pilot Study
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.
Read the detailed description
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.
OJECTIVES
To investigate the effect of extracorporeal shockwave lithotripsy on the effect of change in blood pressure in patients with known hypertension.
STUDY PROTOCOL:
Patients fulfilled the inclusion and exclusion criteria specific to this study will be prospectively recruited. After obtaining informed consent, patients will be randomized to either treatment group or control group.
Baseline information, including age, years of diagnosed to have hypertension, current medical usage, other comorbidities, BMI etc. will be collected from patients. All SWL would be performed in the Lithotripsy and Uro-investigation Centre of the Prince of Wales Hospital, and treated by Modulith SLX-F2 Connect (Storz Medical, Switzerland), an electromagnetic lithotriptor. The treatment would be performed as standard care in our hospital. After SWL, the patient would be follow-up in clinic as usual. During the 6 months study period, patients are strongly advised to avoid change in hypertensive medication.
Blood pressure assessment:
During each blood pressure assessment, the following procedure will be performed:
- 24-hour blood pressure monitoring - 24-h non-invasive ambulatory BP and HR monitoring was performed using a validated device and followed the recommended approached. 11 The blood pressure measurement would be programmed to measure BP every 15 min. Each recording will be started in the morning and performed throughout a full 24-h period, during which subjects are allowed to follow their normal daily routine. The analysis of 24-h BP recordings are preceded by removal of artifacts, according to previously described editing criteria. 12 Recordings are excluded from the analysis when > 10% of all readings or more than one reading per hour is missed. Computed analysis of the individual recordings provided 24-h, night-time (23.00-07.00 h), morning-time (0.7.00-12.00 h), and afternoon/evening-time (12.00- 23.00 h) mean values of SBP, DBP, and HR.
- Clinic blood pressure measurement At each visit, blood pressure will be measured after patient rested for more than 10 minutes, with repeated measurement 5 minutes apart. The mean blood pressure will be recorded.
- Any changes in antihypertensive drugs and reasons
- Any adverse events.
The result collected will be used for further analysis
- Conditions
- Hypertension, Renal Stone
- Being tested
- Extracorporeal shock wave lithotripsy
- Keywords
- Worsening hypertension, Renal stone
- Medical subject headings
- Hypertension, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave lithotripsyProcedure or surgery
A minimally invasive treatment for renal stone which was first introduced in early 1980's. It tries to fragment the renal stones by high-energy shockwave at the kidney from the outside.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Active comparator | immediate extracorporeal shock wave lithotripsy - subject will have SWL arranged in the next available list Receives: Procedure: Extracorporeal shock wave lithotripsy |
| Control Arm | No intervention | delayed extracorporeal shock wave lithotripsy - subject will have SWL done 6 months later |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in mean 24hr systolic and diastolic blood pressure measurement
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.
Measured: Baseline, 6 months
Secondary outcomes (9)
Change in mean night time diastolic and systolic blood pressure
For treatment arm, the changes in mean night time systolic and diastolic blood pressure measurement before SWL and 6 monthes after SWL For control arm, the changes in mean night time systolic and diastolic blood pressure measurement right after randomization and in 6 months.
Measured: Baseline, 6 months
Change in mean night time heart rate
For treatment arm, the changes in mean heart rate before SWL and 6 monthes after SWL For control arm, the changes in mean night time heart rate right after randomization and in 6 months.
Measured: Baseline, 6 months
Change in mean morning-time diastolic and systolic blood pressure
For treatment arm, the changes in mean morning-time systolic and diastolic blood pressure measurement before SWL and 6 monthes after SWL For control arm, the changes in mean morning-time systolic and diastolic blood pressure measurement right after randomization and in 6 months.
Measured: Baseline, 6 months
Change in mean morning-time heart rate
For treatment arm, the changes in mean morning-time heart rate before SWL and 6 monthes after SWL For control arm, the changes in mean morning-time heart rate right after randomization and in 6 months.
Measured: Baseline, 6 months
Change in mean afternoon/evening diastolic and systolic blood pressure
For treatment arm, the changes in mean afternoon/evening systolic and diastolic blood pressure measurement before SWL and 6 monthes after SWL For control arm, the changes in mean afternoon/evening systolic and diastolic blood pressure measurement right after randomization and in 6 months.
Measured: Baseline, 6 months
Change in mean afternoon/evening heart rate
For treatment arm, the changes in mean afternoon/evening heart rate before SWL and 6 monthes after SWL For control arm, the changes in mean afternoon/evening heart rate right after randomization and in 6 months.
Measured: Baseline, 6 months
Change in mean 24hr heart rate
For treatment arm, the changes in mean 24hr heart rate measurement before SWL and 6 monthes after SWL For control arm, the changes in mean 24hr heart rate measurement right after randomization and in 6 months.
Measured: Baseline, 6 months
The need of add-on therapy for hypertension
Any add-on anti-hypertensive drugs in 6 months time
Measured: 6 months
Any adverse effects after SWL
Any adverse effects comparing the treatment arm and control arm during study period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 Jan 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Why it stopped: Due to funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi Fai NG, Chinese University of Hong Kong
- Investigators
- Chi Fai NG, Md, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714477
- Sponsor's protocol ID
- CRE 2018.276
- Status last verified
- Feb 2021
- First submitted
- 15 Oct 2018
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No individual participant data will be shared to other researchers outside CUHK Urology unit
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study to Investigate the Effect of Extracorporeal Shockwave Lithotripsy on Blood Pressure Control in Patients With Hypertension - a Pilot Study
- ClinicalTrials.gov ID
- NCT03714477
- Acronym / sponsor ID
- CRE 2018.276
- Conditions
- Hypertension, Renal Stone
- Keywords
- Worsening hypertension, Renal stone
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 22 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
OJECTIVES
To investigate the effect of extracorporeal shockwave lithotripsy on the effect of change in blood pressure in patients with known hypertension.
STUDY PROTOCOL:
Patients fulfilled the inclusion and exclusion criteria specific to this study will be prospectively recruited. After obtaining informed consent, patients will be randomized to either treatment group or control group.
Baseline information, including age, years of diagnosed to have hypertension, current medical usage, other comorbidities, BMI etc. will be collected from patients. All SWL would be performed in the Lithotripsy and Uro-investigation Centre of the Prince of Wales Hospital, and treated by Modulith SLX-F2 Connect (Storz Medical, Switzerland), an electromagnetic lithotriptor. The treatment would be performed as standard care in our hospital. After SWL, the patient would be follow-up in clinic as usual. During the 6 months study period, patients are strongly advised to avoid change in hypertensive medication.
Blood pressure assessment:
During each blood pressure assessment, the following procedure will be performed:
- 24-hour blood pressure monitoring - 24-h non-invasive ambulatory BP and HR monitoring was performed using a validated device and followed the recommended approached. 11 The blood pressure measurement would be programmed to measure BP every 15 min. Each recording will be started in the morning and performed throughout a full 24-h period, during which subjects are allowed to follow their normal daily routine. The analysis of 24-h BP recordings are preceded by removal of artifacts, according to previously described editing criteria. 12 Recordings are excluded from the analysis when > 10% of all readings or more than one reading per hour is missed. Computed analysis of the individual recordings provided 24-h, night-time (23.00-07.00 h), morning-time (0.7.00-12.00 h), and afternoon/evening-time (12.00- 23.00 h) mean values of SBP, DBP, and HR.
- Clinic blood pressure measurement At each visit, blood pressure will be measured after patient rested for more than 10 minutes, with repeated measurement 5 minutes apart. The mean blood pressure will be recorded.
- Any changes in antihypertensive drugs and reasons
- Any adverse events.
The result collected will be used for further analysis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Active comparator | Procedure: Extracorporeal shock wave lithotripsyimmediate extracorporeal shock wave lithotripsy - subject will have SWL arranged in the next available list |
| Control Arm | No intervention | –delayed extracorporeal shock wave lithotripsy - subject will have SWL done 6 months later |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients had previous SWL, kidney surgery, percutaneous nephrolithotomy, etc.
- Patients with stones obviously required more than one section of SWL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shock wave lithotripsyA minimally invasive treatment for renal stone which was first introduced in early 1980's. It tries to fragment the renal stones by high-energy shockwave at the kidney from the outside. | Procedure or surgery | Treatment Arm |
Primary outcome
The changes in mean 24hr systolic and diastolic blood pressure measurement
Time frame: 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.
9 secondary outcomes
Change in mean night time diastolic and systolic blood pressure
Time frame: Baseline, 6 months
Change in mean night time heart rate
Time frame: Baseline, 6 months
Change in mean morning-time diastolic and systolic blood pressure
Time frame: Baseline, 6 months
Change in mean morning-time heart rate
Time frame: Baseline, 6 months
Change in mean afternoon/evening diastolic and systolic blood pressure
Time frame: Baseline, 6 months
Change in mean afternoon/evening heart rate
Time frame: Baseline, 6 months
Change in mean 24hr heart rate
Time frame: Baseline, 6 months
The need of add-on therapy for hypertension
Time frame: 6 months
Any adverse effects after SWL
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: Undecided. No individual participant data will be shared to other researchers outside CUHK Urology unit
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Fai NG, Md principal investigator
CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave lithotripsy in people with Hypertension and Renal Stone, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in mean 24hr systolic and diastolic blood pressure measurement (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.