Renal Nerve Denervation(RDN) and Renal Function

Recruiting

• Conditions: Effects of RDN on Renal Function

• Registration Number: NCT05612906
• Lead Sponsor: Zhengrong Huang

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-11-08
• Study First Posted: 2022-11-10
• Primary Completion: 2023-12-31
• Status Verified: 2024-07
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.18<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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of serum creatinine and urea nitrogen before and after RDN operation	Baseline,1week/1 month/6months after RDN operation	Serum creatinine(umol/L, ammonia iminohydrolase assay)and urea nitrogen(umol/L, urease methods) were obtained by blood test.
Changes of glomerular filtration rate before and after RDN operation	Baseline, 6months after RDN operation	Glomerular filtration rate(ml/min) were obtained by ECT

Secondary Outcome Measures

Name	Time	Method
Effect of RDN operation on renal artery	Baseline, 6months after RDN operation	Renal arteries were observed by CT angiography.
Urinary protein/serum creatinine ratio change before and after RDN operation	Baseline,1week/1 month/6months after RDN operation	Urinary protein (mg/L, PRM assay) were tested by urine test.Serum creatinine(umol/L, ammonia iminohydrolase assay) were obtained by blood test.

Trial Locations

Locations (1)

zhengrong Huang; 🇨🇳 Xiamen, Fujian, China