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Renal Denervation Database Research Informed Consent Form

Renal Denervation Database Research Informed Consent Form

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116144
Enrollment
Unknown
Registered
2026-01-06
Start date
2026-01-06
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Resistant hypertension

Interventions

RDN Treatment Group:None

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The individual is>=18 years old and =140 mmHg. 4. Hypertension has been clearly diagnosed. 5. The individual agrees to undergo all study procedures and is capable of and willing to provide written informed consent to participate in this clinical study.

Exclusion criteria

Exclusion criteria: 1. Renal artery anatomy that is not suitable for treatment includes: Major renal artery 50%) or renal aneurysm. Previous history of renal artery intervention, including balloon angioplasty or stenting. Unilateral kidney. 2. The patient has been hospitalized for hypertensive crisis >= 1 time in the past year. Hypertensive crisis: Severely elevated blood pressure (BP), usually above 180/110 mmHg, with progressive or imminent target organ damage, requiring hospitalization, usually admitted to the intensive care unit (ICU) (e.g., with non-digestive (IV) antihypertensives), independent of confirmed medication non-adherence. 3. Patients with ambulatory blood pressure monitoring (ABPM) 24-hour mean systolic blood pressure = 1 episode of orthostatic hypotension (decrease in systolic blood pressure >=20 mmHg or decrease in diastolic blood pressure =10 mmHg within 3 minutes of standing) unrelated to medication changes within the past 1 year or during the screening process, accompanied by symptoms. 7. In addition to nocturnal respiratory support, patients with sleep apnea require long-term oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP). 8. Patients with primary pulmonary hypertension. 9. Patients are known to have secondary hypertension factors such as pheochromocytoma, Cushing's disease, coarctation of the aorta, untreated hyperthyroidism, or primary hyperparathyroidism. 10. Myocardial infarction, unstable angina, syncope or cerebrovascular accident within 3 months of the screening period, or extensive atherosclerosis with intravascular thrombosis or unstable plaque. 11. Patient has scheduled or planned surgery or cardiovascular intervention in the next 6 months. 12. The patient has a situation that prohibits or interferes with the use of the automatic blood pressure monitor specified in the protocol for accurate blood pressure measurement (such as the arm diameter is too large and the cuff cannot be measured; arrhythmia interferes with the pulse sensing of the automatic monitor and does not allow accurate measurement). 13. The patient has severe heart valve stenosis, which the investigator considers contraindicated to significantly lower blood pressure. 14. Individual has any serious disease that, in the opinion of the investigator, may adversely affect the safety and/or efficacy of the participant or the study (e.g., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia). 15. Personal pregnancy, breastfeeding. Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to angiography. Patient has a known, unresolved history of drug use or alcohol dependence, lacks ability to understand or follow instructions, or is unlikely or unable to comply with study follow-up requirements. 16. Have participated in other clinical studies. 17. Patients with a history of organ transplantation.

Design outcomes

Primary

MeasureTime frame
Office Systolic Blood Pressure (SBP);24-hour Ambulatory Systolic Blood Pressure;

Secondary

MeasureTime frame
Plasma Renin Activity;Angiotensin II;Adverse Event Rate;Serum Creatinine;Number of Antihypertensive Drugs;24-hour Ambulatory Diastolic Blood Pressure;Office Diastolic Blood Pressure;

Countries

China

Contacts

Public ContactYong Peng

West China Hospital of Sichuan University

pengyongcd@126.com+86 189 8060 6696

Outcome results

None listed

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