Renal Denervation in Hypertension (DENER-HTN)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 4

Conditions

Hypertension, Resistant to Conventional Therapy

Renal Denervation

Treatments

Procedure: optimized medication regimen

Procedure: renal denervation and optimized medication regimen

Study type

Interventional

Funder types

Other

Identifiers

NCT01570777

P110127

Details and patient eligibility

About

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.

Full 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.

Enrollment

121 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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