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Renal Sympathetic Denervation after Renal Transplantation Study - I

Renal Sympathetic Denervation after Renal Transplantation Study - I - RESTART - I

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37506
Enrollment
10
Registered
2012-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Hypertension

Interventions

Bilateral renal sympathetic denervation with the Symplicity Catheter System*, (Medtronic Ardian).

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Hypertension despite 2 or more anti-hypertensive drugs Functioning transplant kidney in situ

Exclusion criteria

Exclusion criteria: Renal artery stenosis of native of transplant reanl arteries Primary hyperaldosteronisme

Design outcomes

Primary

MeasureTime frame
Procedural success (4-8 ablation per renal artery) without adverse events during hospitalization (death, renal artery dissection, renal or peripheral embolisation, major bleeding). Blood pressure reduction at 6 months, by 24-h RR measurement.—

Secondary

MeasureTime frame
Efficacy endpoints: clinical cardiovascular events, systemic and imaging parameters of left ventricular remodelling, laboratory parameters of sympathetic and RAAS activation, laboratory assessment of parameters of cardiovascular fibrosis and gene expression of cardiovascular fibrosis—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)