Renal Nerve Denervation(RDN) and Renal Function

Effect of RDN on Renal Function

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.

Study Overview

• Status: Recruiting
• Conditions: Effects of RDN on Renal Function

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Zhengrong Huang, M.D.; Phone Number: +8613606028353; Email: huangzhengrong@xmu.edu.cn

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Recruiting
      • zhengrong Huang
      • Contact: Zhengrong Huang, M.D.; Phone Number: +8613606028353; Email: huangzhengrong@xmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with refractory hypertension

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of RDN operation on renal artery	Renal arteries were observed by CT angiography.	Baseline, 6months after RDN operation
Urinary protein/serum creatinine ratio change before and 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.	Baseline,1week/1 month/6months after RDN operation

Collaborators and Investigators

• Sponsor: Zhengrong Huang

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022-Renal nerve denervation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No