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SYMPATHY-NTX study Catheter-based Renal Sympathectomy for Hypertension after Kidney Transplantation - a feasibility study.

SYMPATHY-NTX study Catheter-based Renal Sympathectomy for Hypertension after Kidney Transplantation - a feasibility study. - SYMPATHY-NTX study

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42071
Enrollment
20
Registered
2015-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

therapy resistant hypertension in renal transplant recipients

Interventions

Intervention: All patients will continue to receive usual antihypertensive treatment according to prevailing guidelines. Percutaneous renal denervation of the native kidneys will be performed at the
hypertension
kidney transplantation
renal denervation

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age 18-75 years - First kidney transplant in situ >6 months prior to randomization - Urine measured creatinine clearance * 30 ml/min - Radiological evidence for residual flow in the renal arteries indicating that they are accessible for the intervention - Mean day-time systolic blood pressure of at least 135 mmHg (using ambulatory blood pressure monitoring) despite the use of at least 3 antihypertensive drugs, or with documented intolerance or contraindication for to 2 or more of the 4 major classes of antihypertensive drugs (ACEi/ARB, calcium channel blockers, betablockers and diuretics) thus being unable to be treated with 3 antihypertensives. - Hemodynamically significant stenosis of the renal artery of the graft as a cause of therapy resistant hypertension has to be (have been) excluded (using MRI).

Exclusion criteria

Exclusion criteria: - (Planned) pregnancy, lactation - Life expectancy

Design outcomes

Primary

MeasureTime frame
Main study parameters/endpoints: Primary endpoint is the change in blood pressure after 6 months (mean day time systolic blood pressure assessed by 24-hour ambulatory measurement).

Secondary

MeasureTime frame
Secondary outcomes include changes in office blood pressure, changes in antihypertensive treatment, plasma catecholamines, renin and aldosterone, eGFR and 24h proteinuria, Moreover, compliance with antihypertensive treatment compliance will be measured using a questionnaire and by detection of antihypertensives in a blood sample.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)