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Trial record 1 of 1 for:    NCT01570777
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Renal Denervation in Hypertension (DENER-HTN)

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ClinicalTrials.gov Identifier: NCT01570777
Recruitment Status : Active, not recruiting
First Posted : April 4, 2012
Last Update Posted : November 4, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hypertension, Resistant to Conventional Therapy Renal Denervation Procedure: renal denervation and optimized medication regimen Procedure: optimized medication regimen Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Resistant Hypertension
Study Start Date : April 2012
Primary Completion Date : May 2014
Estimated Study Completion Date : April 2018
Arms and Interventions

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 Name: TMAOS + DR
optimized medication regimen
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 Name: TMAOS


Outcome Measures

Primary Outcome Measures :
  1. Mean diurnal systolic blood pressure assessed by ABPM [ Time Frame: Baseline to 6 months ]
  2. Cost-effectiveness evaluation [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Antihypertensive medication score [ Time Frame: baseline to 15 months ]
  2. Adverse events of renal denervation [ Time Frame: baseline to 48 months ]
  3. Detailed analysis of blood pressure [ Time Frame: baseline to 15 months ]
  4. Change in average 24-hour and nighttime Systolic Blood Pressure by ambulatory blood pressure monitoring [ Time Frame: baseline to 15 months ]
  5. 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 ]
  6. Change in Systolic/diastolic Blood Pressure by home blood pressure monitoring [ Time Frame: baseline to 15 months ]
  7. Change in office Systolic/diastolic Blood Pressure [ Time Frame: baseline to 15 months ]
  8. Adherence to antihypertensive Medication [ Time Frame: baseline to 15 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570777


Locations
France
CIC Hopital europeen george pompidou
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Marc SAPOVAL, PD, PhD departement of interventional radiology
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01570777     History of Changes
Other Study ID Numbers: P110127
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: October 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Resistant hypertension
Renal denervation
Standardized medication regimen
Endovascular
Primary hypertension
Cardiovascular diseases
Vascular diseases

Additional relevant MeSH terms:
Hypertension
Coronary Vasospasm
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases