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

NCT03714477 | Withdrawn DMC

• 1 other identifier: CRE 2018.276
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Renal Stone

Keywords

Worsening hypertension; Renal stone

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 months

Secondary Outcomes (9)

• Change in mean night time diastolic and systolic blood pressure

  Baseline, 6 months

• Change in mean night time 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

• Change in mean afternoon/evening diastolic and systolic blood pressure

  Baseline, 6 months

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

immediate extracorporeal shock wave lithotripsy - subject will have SWL arranged in the next available list

Procedure: Extracorporeal shock wave lithotripsy

Control Arm

NO INTERVENTION

delayed extracorporeal shock wave lithotripsy - subject will have SWL done 6 months later

Interventions

Extracorporeal shock wave lithotripsy PROCEDURE

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.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Hypertension; Nephrolithiasis

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Chi Fai NG, Md

  CUHK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 22, 2018
• Study Start: January 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: October 30, 2022
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

HK (1)