Study of Catheter Based Renal Denervation Therapy in Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01522430
• Date of registration: 25/01/2012
• Prospective Registration: No
• Primary sponsor: Erasme University Hospital
• Public title: Study of Catheter Based Renal Denervation Therapy in Hypertension DEPART
• Scientific title: DENERVATION OF RENAL SYMPATHETIC ACTIVITY AND HYPERTENSION STUDY
• Date of first enrolment: January 2012
• Target sample size: 120
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01522430
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Belgium

Contacts

• Name: Jean-François ARGACHA, MD
• Affiliation: Erasme Hospital

• Name: ARGACHA Jean francois, MD

• Name: Jean Francois ARGACHA, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- They have a mandatory > 3 antihypertensive medication therapy, including a thiazide
or a loop diuretic (according to the patient's renal function, unless documented
side-effects) and at least one attempt to treat with spironolactone, given at usual
recommended dose since at least 8 weeks, before inclusion,

- A mandatory check list of secondary cause of hypertension has been excluded

- They succeed the pill count test.

- They have a mandatory ambulatory blood pressure monitoring before inclusion with at
least 70% of valid readings during daytime (08:00 am 08:00 pm, using a sampling
frequency of 20 minutes, only devices validated according to
http://www.dableducational.org are permitted), where daytime ambulatory blood
pressure of systolic and/or diastolic blood pressure exceeds 135 mmHg and/or 85 mmHg,
respectively. Daytime ambulatory blood pressure of systolic and/or diastolic blood
pressure below 135 mmHg and/or 85 mmHg, respectively, is acceptable for inclusion in
the study if the patient takes four or more antihypertensive medication (3).

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Renal Function

Ambulatory Blood Pressure

Renal Denervation

Resistant Hypertension

Intervention(s)

Procedure: Renal angiography followed by renal sympathetic denervation

Procedure: Renal angiography alone

Primary Outcome(s)

glomerular filtration rate [Time Frame: 6 month]

Ambulatory systolic and diastolic blood pressure [Time Frame: 6 month]

Secondary Outcome(s)

Biological markers of acute kidney injury [Time Frame: baseline, H2, H6, 1, 3 and 6 months]

Baroreflex sensitivity [Time Frame: 6 month]

Secondary ID(s)

140576

Source(s) of Monetary Support

Please refer to primary and secondary sponsors