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First-in-Human Study of Laparoscopic Renal Denervation in Refractory Hypertension

Laparoscopic Adventitial Renal Denervation (RDN) for Refractory and Drug-Intolerant Hypertension: A First-in-Human Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110131
Enrollment
Unknown
Registered
2025-09-30
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Refractory Hypertension, Drug-Intolerant Hypertension

Interventions

Intervention Group:Laparoscopic Renal Artery Radiofrequency Denervation combined with standardized antihypertensive medication

Sponsors

Fuwai Central China Cardiovascular Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age >=18 and =140 mmHg and =180 mmHg, and office diastolic blood pressure (DBP) >=90 mmHg; 5.Blood pressure remains uncontrolled after at least 28 days of standardized treatment with at least three antihypertensive drugs (including a diuretic) with >=80% compliance; 6.Patient has good compliance, is willing to complete clinical follow-ups, and has signed the informed consent form. 7.24-hour ambulatory SBP >=130 mmHg or daytime average SBP >=135 mmHg.

Exclusion criteria

Exclusion criteria: 1.Secondary hypertension; 2.Unsuitable renal artery anatomy (e.g., diameter >9mm or 50%); 3.Unsuitable for laparoscopic surgery via retroperitoneal approach (e.g., morbid obesity with BMI > 40 kg/m²); 4.Severe renal impairment (eGFR < 45mL/min/1.73m²); 5.Hospitalization for hypertensive crisis within the past year; 6.History of cardiovascular or cerebrovascular events (e.g., myocardial infarction, stroke) within the 6 months prior to screening; 7.Pregnant or planning to become pregnant; 8.Subjects deemed unsuitable for the study by the investigator.

Design outcomes

Primary

MeasureTime frame
Rate of achieving target office systolic blood pressure at 180 days;

Countries

China

Contacts

Public ContactChuanyu Gao

Fuwai Central China Cardiovascular Hospital

gaocy6802@163.com+86 371 58681130

Outcome results

None listed

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