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Renal Denervation in Hypertension

NCT01570777 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2018-10-02

No results posted yet for this study

Summary

The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the effectiveness and costs of renal denervation in addition to standardized medical treatment compared to medical treatment alone in subjects with resistant hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.

Conditions

  • Hypertension, Resistant to Conventional Therapy
  • Renal Denervation

Interventions

PROCEDURE

renal denervation and optimized medication regimen

Patients are treated with the renal denervation plus a standardized optimal antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.

PROCEDURE

optimized medication regimen

Patients are treated with a standardized optimal antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Marc SAPOVAL, PD, PhD · departement of interventional radiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-05-31
Completion
2018-05-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01570777 on ClinicalTrials.gov