Renal Denervation in Hypertension

Phase 4

Completed

• Conditions: Hypertension, Resistant to Conventional Therapy; Renal Denervation
• Interventions: Procedure: renal denervation and optimized medication regimen; Procedure: optimized medication regimen

• Registration Number: NCT01570777
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed Description

The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the efficacy and cost-effectiveness of renal denervation plus standardized optimal antihypertensive treatment compared to standardized optimal antihypertensive treatment alone in patients with proven resistant hypertension. Patients with essential resistant hypertension will first enter a 4-week run-in period during which they will receive a standardized triple combination therapy (diuretic+ ACE inhibitor+ CCB at maximal dose). After 4 weeks of standardized triple therapy patients will be randomized to renal denervation + optimal antihypertensive treatment compared to standardized optimal antihypertensive treatment if daytime ambulatory BP remains ≥ 135 and/or 85 mmHg. Bilateral renal denervation will be performed using the Symplicity Catheter (Medtronic ®) - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery. Study amendment: Extended follow-up of 48 months for all randomized patients.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-04
• Primary Completion: 2014-05
• Study Completion: 2018-05-15
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-28
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• Individual is more than 18 and less than 75 years old at time of randomization
• Essential hypertension diagnosed during a complete work-up within the past 2 years
• Office blood pressure ≥140 and/or 90 mmHg despite a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, including a diuretic
• 2 functional kidneys sizing ≥ 90 mm; eGFR ≥ 40 mL/min/1.73m² (MDRD formula)
• Suitable renal anatomy compatible with the endovascular denervation procedure
• Signed Informed consent
• Confirmed resistant hypertension defined by diurnal ambulatory blood pressure measurement ≥ 135 and/or 85 mmHg after 4 week standardized triple antihypertensive treatment

Exclusion Criteria

• Patients with an estimated glomerular filtration rate (eGFR) of less than 40 mL/min/1.73 m2
• Patients with secondary hypertension
• Kaliemia ≥ 6mmol/L
• Patient with single functioning kidney
• Patient with contrast media allergy
• Patient with any implantable device incompatible with radiofrequency energy delivery
• Patient with contra-indication to the anti-hypertensive standardized medication regimen
• Patient with transient or fixed cerebral ischemia within 3 months before inclusion
• Patient with myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion
• Patient with type 1 diabetes mellitus
• Patient with malignancy within the 5 past years
• Patient with atrial fibrillation and/or a brachial circumference of ≥ 42cm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal denervation	renal denervation and optimized medication regimen	-
optimized medication regimen	optimized medication regimen	optimized medication regimen

Primary Outcome Measures

Name	Time	Method
Mean diurnal systolic blood pressure assessed by ABPM	Baseline to 6 months
Cost-effectiveness evaluation	1 year

Secondary Outcome Measures

Name	Time	Method
Antihypertensive medication score	baseline to 15 months
Adverse events of renal denervation	baseline to 48 months
Detailed analysis of blood pressure	baseline to 15 months
Change in average 24-hour and nighttime Systolic Blood Pressure by ambulatory blood pressure monitoring	baseline to 15 months
Change in average 24-hour, daytime and nighttime diastolic Blood Pressure, pulse pressure and heart rate by ambulatory blood pressure monitoring	baseline to 15 months
Change in Systolic/diastolic Blood Pressure by home blood pressure monitoring	baseline to 15 months
Change in office Systolic/diastolic Blood Pressure	baseline to 15 months
Adherence to antihypertensive Medication	baseline to 15 months

Trial Locations

Locations (1)

CIC Hopital europeen george pompidou; 🇫🇷 Paris, France