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NCT Number: NCT05612906

Renal Nerve Denervation(RDN) and 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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Changes of serum creatinine and urea nitrogen before and after RDN operation

    Time frame: 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.

  2. Changes of glomerular filtration rate before and after RDN operation

    Time frame: Baseline, 6months after RDN operation

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

Secondary outcomes

  1. Effect of RDN operation on renal artery

    Time frame: Baseline, 6months after RDN operation

    Renal arteries were observed by CT angiography.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhengrong Huang, M.D.

CONTACT

[email protected]

+8613606028353

Sponsors and collaborators

Lead sponsor

Zhengrong Huang

Other

Registry information

Official study title

Effect of RDN on Renal Function

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Nov 10, 2022
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.