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Study of Catheter Based Renal Denervation Therapy in Hypertension

NCT01522430 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-01-31

No results posted yet for this study

Summary

The DEPART study end points are to provide conclusive evidence, using a randomized, double blinded, sham procedure controlled study design, that radiofrequency renal denervation:

1. reduces daytime ambulatory blood pressure,
2. improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.

Conditions

  • Resistant Hypertension
  • Renal Denervation
  • Ambulatory Blood Pressure
  • Renal Function

Interventions

PROCEDURE

Renal angiography followed by renal sympathetic denervation

Radiofrequency catheter based therapy for renal denervation: Symplicity catheter will be advanced into the renal artery and connected to a radiofrequency generator. As previously described, four-to-six discrete, low-power radio frequency treatments will be applied along the length of both main renal arteries. At least four radiofrequency applications will be delivered in each renal artery, unless this is not feasible for anatomical reasons.

PROCEDURE

Renal angiography alone

Procedure will start with a local anesthesia of the femoral site to allow the placement of a 4-Fr sheath in the femoral artery, which allows a minimal risk of bleeding to the patient. Using JR-4 or similar diagnostic catheter, a selective renal angiography will be realized.

Sponsors & Collaborators

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Jean-François ARGACHA, MD · Erasme hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-12-31
Completion
2016-12-31

Countries

  • Belgium

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 NCT01522430 on ClinicalTrials.gov