Ultrasound renal denervation for uncontrolled high blood pressure after kidney transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm study enrolling 40 kidney transplant recipients with uncontrolled hypertension despite medication (or documented medication intolerance) to receive bilateral ultrasound renal denervation of their native kidneys using the Paradise® system. Participants must be at least 12 months post-transplant, have stable immunosuppression and an eGFR ≥40 ml/min/1.73m2. The study will track office and 24-hour ambulatory blood pressure, antihypertensive medication use and adherence, and procedure safety over short-term and long-term follow-up. Results will address a gap because prior randomized RDN trials excluded patients with prior renal failure or transplantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* Kidney transplantation ≥ 12 months ago with stable immunosuppressive drug treatment
* Estimated Glomerular Filtration Rate (eGFR) ≥ 40 ml/min/1.73m2
* Office systolic BP ≥ 140 mmHg and a mean 24-hour ambulatory systolic BP ≥ 130 mmHg at screening
* Antihypertensive medication regimen:

  * Stable regimen of at least two antihypertensive drugs of different classes, including a diuretic (defined a thiazide diuretic, loop diuretic or mineralocorticoid receptor antagonist), for at least three months, or
  * Documented intolerance to three classes of antihypertensive drugs, and
  * A change in antihypertensive drug regimen is not anticipated within the oncoming three months.
* Patient is willing and able to provide written informed consent

Exclusion Criteria:

* Native renal artery anatomy not eligible for RDN, defined as at least one of the following conditions:

  * History of renal artery stenting or angioplasty
  * History of renal denervation
  * History of kidney tumors
  * Renal artery diameter \< 3 mm or \> 8 mm
  * Renal artery length \< 20 mm
  * Fibromuscular disease (FMD) of the native renal arteries
  * Renal artery aneurysm
  * Renal artery stenosis \> 30%
* Presence of a remnant transplant kidney after re-transplantation or absence of native kidneys
* Solitary native kidney
* History of intravenous contrast dye allergy or nephropathy
* Iliac/femoral artery stenosis precluding insertion of the Paradise catheter
* Uncorrected, treatable secondary cause of hypertension
* Pregnancy
* Life expectancy \< one year at the discretion of the investigator

Where it's running

• Erasmus University Medical Center
  Rotterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Joost Daemen, MD PhD
• Email: j.daemen@erasmusmc.nl
• Phone: +31107040704

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.