NCT01522430

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

2.9 years

First QC Date

January 25, 2012

Last Update Submit

January 27, 2012

Conditions

Resistant HypertensionRenal DenervationAmbulatory Blood PressureRenal Function

Keywords

Resistant hypertensionRenal denervationAmbulatory blood pressureRenal functionSimplicity catheterSham procedure

Outcome Measures

Primary Outcomes (2)

  • glomerular filtration rate

    Isotopic and 24h urine sample measure of glomerular filtration rate.

    6 month

  • Ambulatory systolic and diastolic blood pressure

    Ambulatory systolic and diastolic blood pressure measured on 24h ABPM device

    6 month

Secondary Outcomes (2)

  • Baroreflex sensitivity

    6 month

  • Biological markers of acute kidney injury

    baseline, H2, H6, 1, 3 and 6 months

Study Arms (2)

Renal angiography followed by renal sympathetic denervation

EXPERIMENTAL

Catheter based therapy for renal denervation using the Simplicity (TM) catheter (Ardian/Medtronic)

Procedure: Renal angiography followed by renal sympathetic denervation

Renal angiography alone

SHAM COMPARATOR

Renal selective angiography using standardized method: Local anesthesia of the femoral site to allow the placement of a 4-Fr sheath in the femoral artery. Using JR-4 or similar diagnostic catheter, a selective renal angiography will be realized.

Procedure: Renal angiography alone

Interventions

Renal angiography followed by renal sympathetic denervationPROCEDURE

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.

Renal angiography followed by renal sympathetic denervation
Renal angiography alonePROCEDURE

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.

Renal angiography alone

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A mandatory check list of secondary cause of hypertension has been excluded
  • They succeed the pill count test.

You may not qualify if:

  • Patients with an eGFR \<30ml/min/m² are excluded,
  • patients with known renal atherosclerotic lesions,
  • previous procedures in the renal arteries,
  • known unsuitable anatomy for the procedure,
  • previous nephrectomy,
  • contrast agent allergy,
  • hyperthyroidia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

RECRUITING

Study Officials

  • Jean-François ARGACHA, MD

    Erasme University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ARGACHA Jean francois, MD

CONTACT

33225555214Jean.Francois.Argacha@erasme.ulb.ac.be

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2012

First Posted

January 31, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2016

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

BE(1)