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A prospective, multicenter, randomized, controlled, double-blind clinical study of wearable low-intensity pulsed ultrasound in the treatment of mild essential hypertension

A prospective, multicenter, randomized, controlled, double-blind clinical study of wearable low-intensity pulsed ultrasound in the treatment of mild essential hypertension

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062427
Enrollment
Unknown
Registered
2022-08-05
Start date
2023-10-18
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

control group :Use a therapeutic device that is identical in appearance and usage to the treatment group, for a total of 14 days.
treatment group:Use a therapeutic device that can emit low-intensity pulsed ultrasound for ultrasound intervention at the marked location on the body surface of the renal hilum, for a total of 14 days

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged 18-65, newly diagnosed by a cardiologist with mild primary systolic-diastolic hypertension (i.e., not currently using antihypertensive drugs), defined as one of the following situations:? Clinic blood pressure measurement results show systolic blood pressure =140mmHg and diastolic blood pressure =90mmHg, and systolic blood pressure <160mmHg and diastolic pressure <100mmHg, with all three measurements on different days reaching the above thresholds;? Dynamic blood pressure monitoring results show 24-hour average systolic/diastolic pressure =130/80mmHg, daytime =135/85mmHg or night-time =120/70mmHg.(2) Body Mass Index (BMI) is between 18.5-23.9;(3) The patient agrees and signs an informed consent form, and can complete follow-ups and examinations during the entire clinical research period.

Exclusion criteria

Exclusion criteria: (1) Secondary hypertension;(2) Existence of uncontrolled comorbidities (comorbidities refer to accompanying uncontrolled active coronary heart disease, heart failure, stroke, peripheral arterial atherosclerosis, kidney disease, diabetes) or other active systemic diseases (including liver, kidney failure disease; malignant tumor; moderate or above anemia; Parkinson's syndrome etc.);(3) Pregnant and lactating women;(4) History of cardio/cerebral pacemaker implantation;(5) Those who need to take anticoagulants long-term for various reasons (including warfarin or new oral anticoagulants such as rivaroxaban, apixaban, edoxaban, dabigatran, etc.);(6) Patients who have undergone renal artery RF ablation for hypertension;(7) Having active poorly controlled mental illness, including delusions, hallucinations or suicidal intentions, etc.;(8) History of alcohol or drug addiction;(9) Those who are simultaneously participating in other clinical research.

Design outcomes

Primary

MeasureTime frame
24-hour ambulatory systolic blood pressure;

Secondary

MeasureTime frame
Routine blood test;routine urine test;

Countries

China

Contacts

Public ContactDong Huang

The Sixth People's Hospital Affiliated to Shanghai Jiaotong University,School of Medicine

huangdong1004@126.com+86 189 3017 3998

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026