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Recruiting NCT05612906

Renal Nerve Denervation(RDN) and Renal Function

Observational Effects of RDN on Renal Function

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Effects of RDN on Renal Function. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of RDN on Renal Function

Overview

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.

Primary outcome measures

  • Changes of serum creatinine and urea nitrogen before and after RDN operation [Time frame: Baseline,1week/1 month/6months after RDN operation]
  • Changes of glomerular filtration rate before and after RDN operation [Time frame: Baseline, 6months after RDN operation]
Secondary outcome measures (2)
  • Effect of RDN operation on renal artery [Time frame: Baseline, 6months after RDN operation]
  • Urinary protein/serum creatinine ratio change before and after RDN operation [Time frame: Baseline,1week/1 month/6months after RDN operation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • zhengrong Huang — Xiamen

Identifiers

NCT: NCT05612906 · 2022-Renal nerve denervation

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗