Overview

This trial is active, not recruiting.

Conditions hypertension, resistant to conventional therapy, renal denervation
Treatments renal denervation and optimized medication regimen, optimized medication regimen
Phase phase 4
Sponsor Assistance Publique - Hôpitaux de Paris
Start date April 2012
End date May 2014
Trial size 121 participants
Trial identifier NCT01570777, P110127

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
renal denervation and optimized medication regimen TMAOS + DR
Patients are treated with the renal denervation plus a standardized optimal antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.
(Other)
optimized medication regimen
optimized medication regimen TMAOS
Patients are treated with a standardized optimal antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.

Primary Outcomes

Measure
Mean diurnal systolic blood pressure assessed by ABPM
time frame: Baseline to 6 months
Cost-effectiveness evaluation
time frame: 1 year

Secondary Outcomes

Measure
Antihypertensive medication score
time frame: baseline to 15 months
Adverse events of renal denervation
time frame: baseline to 48 months
Detailed analysis of blood pressure
time frame: baseline to 15 months
Change in average 24-hour and nighttime Systolic Blood Pressure by ambulatory blood pressure monitoring
time frame: 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
time frame: baseline to 15 months
Change in Systolic/diastolic Blood Pressure by home blood pressure monitoring
time frame: baseline to 15 months
Change in office Systolic/diastolic Blood Pressure
time frame: baseline to 15 months
Adherence to antihypertensive Medication
time frame: baseline to 15 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Renal Denervation in Patients With Resistant Hypertension
Principal investigator Marc SAPOVAL, PD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.