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A Study to Investigate the Effect of Extracorporeal Shockwave Lithotripsy on Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03714477
Recruitment Status : Not yet recruiting
First Posted : October 22, 2018
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Chi Fai NG, Chinese University of Hong Kong

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Hypertension Renal Stone Procedure: Extracorporeal shock wave lithotripsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones Shock

Arm Intervention/treatment
Active Comparator: Treatment Arm
immediate extracorporeal shock wave lithotripsy - subject will have SWL arranged in the next available list
Procedure: Extracorporeal shock wave lithotripsy
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.

No Intervention: Control Arm
delayed extracorporeal shock wave lithotripsy - subject will have SWL done 6 months later



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in mean night time diastolic and systolic blood pressure [ Time Frame: Baseline, 6 months ]
    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.

  2. Change in mean night time heart rate [ Time Frame: Baseline, 6 months ]
    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.

  3. Change in mean morning-time diastolic and systolic blood pressure [ Time Frame: Baseline, 6 months ]
    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.

  4. Change in mean morning-time heart rate [ Time Frame: Baseline, 6 months ]
    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.

  5. Change in mean afternoon/evening diastolic and systolic blood pressure [ Time Frame: Baseline, 6 months ]
    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.

  6. Change in mean afternoon/evening heart rate [ Time Frame: Baseline, 6 months ]
    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.

  7. Change in mean 24hr heart rate [ Time Frame: Baseline, 6 months ]
    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.

  8. The need of add-on therapy for hypertension [ Time Frame: 6 months ]
    Any add-on anti-hypertensive drugs in 6 months time

  9. Any adverse effects after SWL [ Time Frame: 6 months ]
    Any adverse effects comparing the treatment arm and control arm during study period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients had previous SWL, kidney surgery, percutaneous nephrolithotomy, etc.
  • Patients with stones obviously required more than one section of SWL

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714477


Contacts
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Contact: Chi Fai NG, MD 3505 2625 ngcf@surgery.cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Chi Fai NG, Md CUHK
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Responsible Party: Chi Fai NG, Clinical Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03714477    
Other Study ID Numbers: CRE 2018.276
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No individual participant data will be shared to other researchers outside CUHK Urology unit

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chi Fai NG, Chinese University of Hong Kong:
Worsening hypertension
Renal stone
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Hypertension
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical