Renal Denervation in Hypertension (DENER-HTN)

September 28, 2018 updated by: Assistance Publique - Hôpitaux de Paris

Renal Denervation in Patients With Resistant Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • CIC Hopital europeen george pompidou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal denervation
Procedure: renal denervation and optimized medication regimen
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 Names:
  • TMAOS + DR
Other: optimized medication regimen
Procedure: optimized medication regimen
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.
Other Names:
  • TMAOS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Antihypertensive medication score
Time Frame: baseline to 15 months
baseline to 15 months
Adverse events of renal denervation
Time Frame: baseline to 48 months
baseline to 48 months
Detailed analysis of blood pressure
Time Frame: baseline to 15 months
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
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
baseline to 15 months
Change in Systolic/diastolic Blood Pressure by home blood pressure monitoring
Time Frame: baseline to 15 months
baseline to 15 months
Change in office Systolic/diastolic Blood Pressure
Time Frame: baseline to 15 months
baseline to 15 months
Adherence to antihypertensive Medication
Time Frame: baseline to 15 months
baseline to 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Marc SAPOVAL, PD, PhD, departement of interventional radiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 15, 2018

Study Registration Dates

First Submitted

April 2, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Actual)

October 2, 2018

Last Update Submitted That Met QC Criteria

September 28, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P110127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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