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Cryofocus Cryoablation System on Renal sympathetic Nerve (Cryo-RDN) for uncontrollable hypertension: a prospective, multicenter, randomized controlled trial

Cryofocus Cryoablation System on Renal sympathetic Nerve (Cryo-RDN intervention) for uncontrollable hypertension: a prospective, multicenter, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017707
Enrollment
Unknown
Registered
2018-08-10
Start date
2018-10-15
Completion date
Unknown
Last updated
2018-08-20

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

Conditions

Hypertension

Interventions

Trail team:Hypertension medicion+Cryo-RDN intervention
Control team:Hypertension medicion+Renal

Sponsors

Zhongshan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years male or female; 2. Individual has the history of taking antihypertensive medicine =3 months; after at least 28 days(at least two types) of antihypertensive medicine according to the protocal, the office systolic blood pressue=140 mmHg and the office distolic blood pressure =90 mmHg; then the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP =135 mmHg; 3. Individual does agree to cooperate with the research process and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Individual has secondary hypertension; 2. Individual has the history of renal intervention therapy(such as stents); 3.Individual has renal artery disease or morphological variation, including: aneurysm, stenosis, severe renal artery calcification, dissection, multiple renal artery, etc.; 4. Individual has experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident, or has widespread atherosclerosiswith documented intravascular thrombosis within 6 months of the screening period; 5. Individual has cardiac valvular disease with significant hemodynamic changes; 6. Individual has uncontrolled pulmonary hypertension; 7. Individual has eGFR of 1.5); 9. Individual has ICD history; 10. Individual has acute or severe systemic infections; 11. Individual has type 1 diabetes mellitus; 12. Individual has require long-term oxygen intake or mechanical ventilation other than nocturnal sleep apnea; 13. Individual has contrast sensitivity; 14. Individual has pregnant, lactating, and preparing for pregnancy; 15.Individual has alcohol and other drug addicts, mental patients; 16. Individual has disease which may adversely affect the safety of the subject or clinical study; 17. Individual has participated in clinical studies of other drugs or instruments; 18. The researchers considered it inappropriate to participate in this clinical study of patients.

Design outcomes

Primary

MeasureTime frame
24-hour ambulatory systolic blood pressure;

Secondary

MeasureTime frame
24-hour ambulatory diastolic blood pressure;24-hour mean blood pressure;Office systolic blood pressure;The change of medicine types;The change of medicine dose;Quantifying medication compliance;Evaluation of instrument performance;Major adverse events occur;

Countries

China

Contacts

Public ContactJunbo Ge

Zhongshan Hospital Fudan University

ge.junbo@zs-hospital.sh.cn+86 021-54231990-608501

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 1, 2026