Renal Nerve Denervation(RDN) and Renal Function

NCT05612906 | Recruiting

• 1 other identifier: 2022-Renal nerve denervation
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Current studies have found the efficacy of RDN in the treatment of hypertension, however, the safety of RDN in renal function is still lacking. Therefore, the investigators are aimed to study the effect of RDN on renal function.

Conditions

Effects of RDN on Renal Function

Outcome Measures

Primary Outcomes (2)

• Changes of serum creatinine and urea nitrogen before and after RDN operation

  Serum creatinine(umol/L, ammonia iminohydrolase assay)and urea nitrogen(umol/L, urease methods) were obtained by blood test.

  Baseline,1week/1 month/6months after RDN operation

• Changes of glomerular filtration rate before and after RDN operation

  Glomerular filtration rate(ml/min) were obtained by ECT

  Baseline, 6months after RDN operation

Secondary Outcomes (2)

• Effect of RDN operation on renal artery

  Baseline, 6months after RDN operation

• Urinary protein/serum creatinine ratio change before and after RDN operation

  Baseline,1week/1 month/6months after RDN operation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with refractory hypertension

You may qualify if:

• \<age≤75 years; 2.clinic blood pressure ≥ 140/90 mmHg or 24-hour ambulatory blood pressure monitoring average blood pressure ≥ 135/85 mmHg after taking 3 or more antihypertensive drugs for more than 4 weeks; 3.essential hypertension, renal parenchymal hypertension, or hypertension patients who are willing to receive RDN ; 4.who signed informed consent and were approved by the Ethics Committee of the First Affiliated Hospital of Xiamen University.

You may not qualify if:

• pregnant women or lactating patients;
• identified secondary hypertension or Pseudo hypertension;
• whose renal arteries were unsuitable for ablation
• obvious bleeding tendency and blood system diseases;
• malignant tumors or end-stage diseases; ⑥Severe peripheral vascular disease, abdominal aortic aneurysm; ⑦A history of the acute coronary syndrome within two weeks; ⑧acute or severe systemic infection; ⑨drug or alcohol dependence or refusal to sign informed consent.

Sponsors & Collaborators

• Zhengrong Huang: lead

Study Sites (1)

zhengrong Huang

Xiamen, Fujian, 361000, China

RECRUITING

Central Study Contacts

Zhengrong Huang, M.D.

CONTACT

+8613606028353; huangzhengrong@xmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: November 10, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2025

Record last verified: 2024-07

Locations

CN (1)